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Bernadette Mannaerts - One of the best experts on this subject based on the ideXlab platform.
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Open Access
2013Co-Authors: John L Frattarelli, Han Witjes, Torbjörn Hillensjö, Frank J.m. Broekmans, Keith Gordon, A Elbers, Bernadette MannaertsAbstract:Clinical impact of LH rises prior to and during Ganirelix treatment started on day 5 or on day 6 of ovarian stimulatio
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Clinical impact of LH rises prior to and during Ganirelix treatment started on day 5 or on day 6 of ovarian stimulation
Reproductive biology and endocrinology : RB&E, 2013Co-Authors: John L Frattarelli, Han Witjes, Torbjörn Hillensjö, Frank J.m. Broekmans, Jolanda Elbers, Keith Gordon, Bernadette MannaertsAbstract:Background: We sought to evaluate the incidence and clinical impact of luteinizing hormone (LH) rises prior to and during gonadotropin-releasing hormone (GnRH) antagonist treatment started on day 5 or 6 of ovarian stimulation with recombinant follicle-stimulating hormone (rFSH). Methods: Pooled data from three trials with the GnRH antagonist Ganirelix started on day 5 (n = 961) and from five trials with Ganirelix started on day 6 (n = 1135) of ovarian stimulation with rFSH were retrospectively analyzed. Results: The incidence of LH rises (LH ≥ 10.0 IU/L) prior to Ganirelix treatment was 2.3% and 6.6% on Ganirelix start days 5 and 6, respectively (P < 0.01). During Ganirelix treatment this incidence was 1.2% and 2.3%, respectively (P = 0.06). Women with LH rise on day 5o r 6h ad ah igher ovarian response with more oocytes recovered, mean ±S D, 12.9 ±8 .5 versus no LH rise, 10.2 ± 6.4 (P < 0.01). In women with and without LH rise prior to Ganirelix treatment the ongoing pregnancy rates were similar (26.0% vs 29.9%; odds ratio [OR], 0.89; 95% confidence interval [CI], 0.55-1.44). Women with LH rise during Ganirelix treatment had a lower ovarian response with 7.5 ± 6.7 oocytes recovered versus no LH rise, 10.2 ± 6.4 (P = 0.02) and a tendancy for a lower chance of ongoing pregnancy (16.7% vs 29.9%; OR, 0.52; 95% CI, 0.21-1.26). Conclusions: The incidence of early and late LH rises was low but may be further reduced by initiating Ganirelix on stimulation day 5 rather than on day 6. In contrast to women with an early LH rise, women with a late LH rise may have a reduced chance of ongoing pregnancy.
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A randomized controlled trial of the GnRH antagonist Ganirelix in Chinese normal responders: high efficacy and pregnancy rates
Gynecological endocrinology : the official journal of the International Society of Gynecological Endocrinology, 2012Co-Authors: Jie Qiao, Hanwang Zhang, Hua Chen, Jan I. Olofsson, Han Witjes, Esther Heijnen, Bernadette MannaertsAbstract:Gonadotropin-releasing hormone (GnRH) antagonists for controlled ovarian stimulation (COS) were only recently introduced into China. The efficacy and safety of the GnRH antagonist Ganirelix was assessed in a multicenter, controlled, open-label study, in which Chinese women were randomized to either Ganirelix (n = 113) or a long GnRH agonist protocol of triptorelin (n = 120). The primary end point was the amount of recombinant follicle-stimulating hormone (rFSH) required to meet the human chorionic gonadotropin criterion (three follicles ≥17 mm). The amount of rFSH needed was significantly lower for Ganirelix (1272 IU) vs. triptorelin (1416 IU; P< 0.001). Ongoing pregnancy rates per started cycle were 39.8% (Ganirelix) and 39.2% (triptorelin). Although both treatments were well tolerated, cancellation due to risk of ovarian hyperstimulation syndrome (OHSS) was less frequent with Ganirelix (1.8%) than triptorelin (7.5%) (P = 0.06). Less rFSH was needed in the Ganirelix protocol than the long GnRH agonist protocol, with fewer reported cases of OHSS and similar pregnancy rates.
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Large prospective, pregnancy and infant follow-up trial assures the health of 1000 fetuses conceived after treatment with the GnRH antagonist Ganirelix during controlled ovarian stimulation
Human reproduction (Oxford England), 2010Co-Authors: Maryse Bonduelle, Bernadette Mannaerts, J. Oberyé, Paul DevroeyAbstract:background: A concern for new compounds in fertility treatment is the possible risk of perinatal complications or birth defects. To demonstrate long-term safety of Ganirelix (GnRH antagonist) treatment in controlled ovarian stimulation (COS), follow-up data on pregnancy and neonatal outcome were analysed for 1000 fetuses (≥16 gestational weeks). methods: Obstetrical and neonatal data on 839 pregnancies, resulting in 969 live born infants after Ganirelix treatment were compared with a historical cohort of 753 pregnancies after long GnRH agonist (buserelin) treatment, resulting in 963 live born infants. All treatment cycles were performed in a single fertility centre. The infants were examined at the Universitair Ziekenhuis Brussel using an identical follow-up protocol. Incidence of major malformations (i.e. causing functional impairment or requiring surgical correction) was the primary end-point and was analysed by logistic regression including treatment, age of mother, IVF method and pregnancy type (singleton/multiple) as independent variables. results: There were no relevant differences in maternal characteristics, fertilization method and pregnancy and delivery complications between the Ganirelix and historical GnRH agonist groups. There were relatively more multiple pregnancies in the historical GnRH agonist group (31.9%) than the Ganirelix group (18.7%; P , 0.0001). The groups were comparable with respect to pregnancy loss after 16 weeks gestation. The incidence of major congenital malformations in fetuses with gestational age ≥26 weeks was 5.0% in the Ganirelix cohort versus 5.4% in the historical GnRH agonist group (odds ratio 0.94, 95% confidence interval, 0.62–1.42).
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similar endometrial development in oocyte donors treated with either high or standard dose gnrh antagonist compared to treatment with a gnrh agonist or in natural cycles
Human Reproduction, 2005Co-Authors: Carlos Simón, J. Oberyé, Jose Bellver, C Vidal, Ernesto Bosch, J A Horcajadas, Christopher R Murphy, Susan M Adams, Anne Riesewijk, Bernadette MannaertsAbstract:BACKGROUND: This descriptive study evaluates the impact on endometrial development of standard and high doses of a GnRH antagonist in stimulated cycles compared with GnRH agonist and natural cycles. METHODS: Thirty-one oocyte donors were treated with a combination of rFSH and 0.25 mg/day Ganirelix (standard dose), 2 mg/day Ganirelix (high dose) or 0.6 mg/day buserelin (long protocol). Vaginal progesterone (200 mg/day) was administered in the luteal phase. Endometrial biopsies were performed 2 and 7 days after HCG administration. Additional biopsies were carried out in a subset of 12 subjects, 2 and 7 days following the LH peak of their previous natural cycle. Biopsies were evaluated histologically and by scanning electron microscopy. Gene expression profiles were also studied. RESULTS: At HCG +2, all the parameters studied were similar in all the groups and comparable to those observed in the natural cycle. At HCG +7, endometrial dating, steroid receptors and the presence of pinopodes were comparable in both GnRH antagonist groups and in the natural cycle. In buserelin group, endometrial dating and pinopode expression suggested an arrested endometrial development. For window of implantation genes, expression patterns were closer to those in the natural cycle following standard- or high-dose Ganirelix than after buserelin administration. CONCLUSION: No relevant alteration was observed in the endometrial development in the early and mid-luteal phases in women undergoing controlled ovarian stimulation for oocyte donation following daily treatment with a standard- or high-dose GnRH antagonist. In addition, the endometrial development after GnRH antagonist mimics the natural endometrium more closely than after GnRH agonist.
Klaus Diedrich - One of the best experts on this subject based on the ideXlab platform.
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Gonadotropin-Releasing Hormone Antagonists for Assisted Reproductive Techniques
Drugs, 2004Co-Authors: Georg Griesinger, Ricardo E. Felberbaum, A. Schultze-mosgau, Klaus DiedrichAbstract:Gonadotropin-releasing hormone (GnRH) antagonists have been tested extensively in ovarian stimulation protocols for assisted reproductive techniques (ART). GnRH antagonists immediately and rapidly inhibit gonadotropin release by the anterior pituitary gland by competitive blockage of the GnRH receptor, preventing and interrupting luteinising hormone surges in controlled ovarian hyperstimulation for infertility treatment. A review of the available literature on GnRH antagonists for ART is presented, focusing on the pharmacological and clinical properties of the two compounds available on the market, cetrorelix and Ganirelix. Both cetrorelix and Ganirelix are well tolerated and effective drugs for controlled ovarian hyperstimulation and are of comparable value for infertility treatment. Cetrorelix is available as a 0.25mg preparation for daily injections and as a 3mg intermediate depot preparation. Ganirelix is available as a 0.25mg preparation for daily injections. Currently, two treatment protocols are used in clinical practice: the GnRH antagonist multiple-dose protocol and the GnRH antagonist single-dose protocol. Both protocols are effective and well tolerated. Cetrorelix and Ganirelix have not yet been directly compared in a clinical trial; nor have the single-dose and the multiple-dose approaches been compared in a randomised, controlled trial. Data to compare these compounds in clinical terms can be extrapolated only from results of phase II dose-finding studies and phase III studies comparing GnRH agonist cycles with GnRH antagonists in single- and multiple-dose protocols. Therefore, all conclusions on clinical differences between cetrorelix and Ganirelix should remain tentative, as they are based on a limited amount of available data. Randomised, controlled trials comparing cetrorelix and Ganirelix are warranted to further evaluate benefits and drawbacks of individual GnRH antagonists. Furthermore, more data are needed to determine the efficacy and safety of cetrorelix and Ganirelix in established treatment protocols in patients other than those included in clinical trials investigating new drugs, such as ‘poor responders’, patients with polycystic ovaries, patients with a history of allergy or overweight patients.
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Gonadotropin-releasing hormone antagonists for assisted reproductive techniques: are there clinical differences between agents?
Drugs, 2004Co-Authors: Georg Griesinger, Ricardo E. Felberbaum, A. Schultze-mosgau, Klaus DiedrichAbstract:Gonadotropin-releasing hormone (GnRH) antagonists have been tested extensively in ovarian stimulation protocols for assisted reproductive techniques (ART). GnRH antagonists immediately and rapidly inhibit gonadotropin release by the anterior pituitary gland by competitive blockage of the GnRH receptor, preventing and interrupting luteinising hormone surges in controlled ovarian hyperstimulation for infertility treatment. A review of the available literature on GnRH antagonists for ART is presented, focusing on the pharmacological and clinical properties of the two compounds available on the market, cetrorelix and Ganirelix. Both cetrorelix and Ganirelix are well tolerated and effective drugs for controlled ovarian hyperstimulation and are of comparable value for infertility treatment. Cetrorelix is available as a 0.25mg preparation for daily injections and as a 3mg intermediate depot preparation. Ganirelix is available as a 0.25mg preparation for daily injections.
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Gonadotrophin-releasing hormone antagonists: will they replace the agonists?
Reproductive biomedicine online, 2003Co-Authors: Ricardo Felberbaum, Klaus DiedrichAbstract:Modern gonadotrophin-releasing hormone (GnRH) antagonists such as cetrorelix and Ganirelix reliably prevent premature LH surges in controlled ovarian hyperstimulation for assisted reproductive technologies. Cetrorelix and Ganirelix are safe and effective compounds. Because of their distinct pharmacological mode of action, it has been possible to achieve a significant reduction of treatment time. Fertilization and pregnancy rates are comparable to those obtained in agonist protocols for ovarian stimulation. No allergic or hyperergic reactions have been reported, and patient compliance is excellent. The fact that GnRH antagonists allow an immediate suppression of gonadotrophin concentrations while preserving pituitary responsiveness to endogenous GnRH provides enormous flexibility in treatment. GnRH antagonists have helped to overcome some major disadvantages of GnRH agonists, especially of the long protocol, which is currently the standard protocol for ovarian stimulation. The mistaken administration of antagonists during early pregnancy is not possible, since they are only administered during ovarian stimulation when a premature LH surge may be imminent. They are used in the spontaneous cycle or after pretreatment with oral contraceptives. Pregnancy can easily be ruled out by testing for human gonadotrophic hormone before onset of gonadotrophin stimulation on the second or third day of the cycle. Since flare-up effects are absent, there is no risk of cyst formation. Hormonal withdrawal symptoms are eliminated, since no period of pituitary suppression occurs, and therefore exogenous gonadotrophins are not required. Overall, the duration of the stimulation cycle is as short as a normal menstrual cycle. The procedure seems to be safer than the long protocol, since the most serious complication, the occurrence of severe cases of OHSS, is reduced. It is also safe with respect to the course of pregnancies and the health of offspring. Both protocols developed so far, the single dose and multiple dose antagonist protocol, are comparable, utilizing data from the large prospective phase IIIb studies. Although several studies have indicated a slight reduction in pregnancy rate with GnRH antagonists as compared with agonists, this problem may be rectified by developing flexible antagonist regimens designed for individual patients. Introducing flexible GnRH antagonist regimens should be the area of research in the near future.
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Safety aspects of gonadotrophin-releasing hormone antagonists in ovarian stimulation procedures: ovarian hyperstimulation syndrome and health of children born.
Reproductive BioMedicine Online, 2002Co-Authors: Michael Ludwig, Alexander Katalinic, Ricardo Felberbaum, Klaus DiedrichAbstract:The safety of ovarian stimulation procedures or the procedure of assisted reproduction in general can be estimated by various parameters. Two of the most important are the health of children born after the procedure and the incidence of ovarian hyperstimulation syndrome (OHSS). The latter is important because it is the most severe, potentially life-threatening complication of any stimulation procedure. The use of gonadotrophin-releasing hormone (GnRH) antagonists in ovarian stimulation protocols has had no impact on the health of children born. This was proven in 227 children born after the use of cetrorelix and in 73 children born after the use of Ganirelix. To analyse the incidence of OHSS and the impact of GnRH antagonists on clinical pregnancy rates compared with the long protocol, a meta-analysis was done. This showed a reduction of OHSS with the use of cetrorelix. Furthermore, when compared with the long protocol, clinical and ongoing pregnancy rates were not significantly reduced with the use of cetrorelix. Taken together, the use of GnRH antagonists are safe with regard to children's health. The incidence of OHSS does not increase with Ganirelix, and a reduction can be expected with cetrorelix.
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Use of GnRH antagonists in ovarian stimulation for assisted reproductive technologies compared to the long protocol. Meta-analysis.
Archives of gynecology and obstetrics, 2001Co-Authors: Michael Ludwig, Alexander Katalinic, Klaus DiedrichAbstract:The use of GnRH antagonists has revolutionized ovarian stimulation for assisted reproduction. Two GnRH antagonists are clinically available, namely, cetrorelix and Ganirelix. Several studies have directly compared these new stimulation protocols against the long GnRH agonist protocol. To evaluate whether there is a reduction in cases of ovarian hyperstimulation syndrome (OHSS) and/or a reduction in pregnancy rates, a meta-analysis was performed. There was a significant reduction of OHSS cases in the cetrorelix studies (odds ratio, OR, 0.23; 95% confidence interval, CI, 0.10–0.54), but no reduction for Ganirelix (OR 1.13; 95% CI 0.24–5.31). The incidence of OHSS °III cases was reduced in the cetrorelix protocols as compared to the long protocol to a nearly significant degree (OR 0.26; 95% CI 0.07–1.01). Ganirelix did not reduce the incidence of OHSS °III at all (OR 1.08; 95% CI 0.27–4.38). The pregnancy rate per cycle was significantly lower in the Ganirelix protocols than in the long protocol (OR 0.76; 95% CI 0.59–0.98). The studies using cetrorelix showed quite similar, not significantly different results for the antagonist and the long protocol groups for the pregnancy rate per cycle (OR 0.91; 95% CI 0.68–1.22). From the data one can conclude that cetrorelix but not Ganirelix will reduce the incidence of cases of OHSS and that cetrorelix but not Ganirelix will result in the same pregnancy rates as the long protocol. Several possibilities to explain this phenomenon are discussed.
B Mannaerts - One of the best experts on this subject based on the ideXlab platform.
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perinatal outcome of pregnancy after gnrh antagonist Ganirelix treatment during ovarian stimulation for conventional ivf or icsi a preliminary report
Human Reproduction, 2001Co-Authors: F. Olivennes, B Mannaerts, Maryse Bonduelle, Martin J Struijs, P DevroeyAbstract:BACKGROUND: Gonadotrophin-releasing hormone (GnRH) antagonists have been proven safe and effective, with no adverse effects on offspring in animal studies. Careful study of pregnancy outcome in humans is mandatory. METHODS AND RESULTS: This preliminary report includes follow-up data of patients treated with the GnRH antagonist, Ganirelix, during ovarian stimulation for IVF or ICSI. In total, 333 patients were randomized in a multicentre, double-blind, dose-finding study of Ganirelix, at six different doses ranging from 0.0625 to 2 mg. In total, 68 vital intrauterine pregnancies were established that resulted in the birth of 46 singletons, 12 twins and one triplet. Follow-up of the 67 pregnant patients (one subject was lost to follow-up) revealed six miscarriages (9%). Of the 61 subjects with an ongoing pregnancy, two with a singleton pregnancy did not give birth to a live-born infant (one spontaneous abortion in week 19, and one intrauterine death in week 27). The mean gestational age was 39.4 weeks for singleton pregnancies, and 36.6 weeks for multiple pregnancies. In total, 73 infants (33 boys, 40 girls) were born. A birth weight <2500 g was reported for 8.7% and 54.2% of the infants resulting from singleton and twins delivery respectively. One major congenital malformation was diagnosed; a boy with Beckwith– Wiedemann syndrome (exomphalos and macroglossia). Seven minor malformations were reported among five infants. CONCLUSIONS: In this first follow-up study, the incidence of adverse obstetrical and neonatal outcome was comparable with reported incidences for IVF–embryo transfer pregnancies.
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Perinatal outcome of pregnancy after GnRH antagonist (Ganirelix) treatment during ovarian stimulation for conventional IVF or ICSI: a preliminary report
Human reproduction (Oxford England), 2001Co-Authors: F. Olivennes, B Mannaerts, Maryse Bonduelle, Martin J Struijs, Paul DevroeyAbstract:BACKGROUND: Gonadotrophin-releasing hormone (GnRH) antagonists have been proven safe and effective, with no adverse effects on offspring in animal studies. Careful study of pregnancy outcome in humans is mandatory. METHODS AND RESULTS: This preliminary report includes follow-up data of patients treated with the GnRH antagonist, Ganirelix, during ovarian stimulation for IVF or ICSI. In total, 333 patients were randomized in a multicentre, double-blind, dose-finding study of Ganirelix, at six different doses ranging from 0.0625 to 2 mg. In total, 68 vital intrauterine pregnancies were established that resulted in the birth of 46 singletons, 12 twins and one triplet. Follow-up of the 67 pregnant patients (one subject was lost to follow-up) revealed six miscarriages (9%). Of the 61 subjects with an ongoing pregnancy, two with a singleton pregnancy did not give birth to a live-born infant (one spontaneous abortion in week 19, and one intrauterine death in week 27). The mean gestational age was 39.4 weeks for singleton pregnancies, and 36.6 weeks for multiple pregnancies. In total, 73 infants (33 boys, 40 girls) were born. A birth weight
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use of a single bolus of gnrh agonist triptorelin to trigger ovulation after gnrh antagonist Ganirelix treatment in women undergoing ovarian stimulation for assisted reproduction with special reference to the prevention of ovarian hyperstimulation sy
Human Reproduction, 2000Co-Authors: Joseph Itskovitzeldor, B MannaertsAbstract:A new treatment option for patients undergoing ovarian stimulation is the gonadotrophin-releasing hormone (GnRH) antagonist protocol, with the possibility to trigger a mid-cycle LH surge using a single bolus of GnRH agonist, reducing the risk of developing ovarian hyperstimulation syndrome (OHSS) in high responders and the chance of cycle cancellation. This report describes the use of 0.2 mg triptorelin (Decapeptyl®) to trigger ovulation in eight patients who underwent controlled ovarian hyperstimulation with recombinant FSH (rFSH, Puregon®) and concomitant treatment with the GnRH antagonist Ganirelix (Orgalutran®) for the prevention of premature LH surges. All patients were considered to have an increased risk for developing OHSS (at least 20 follicles ≥11 mm and/or serum oestradiol at least 3000 pg/ml). On the day of triggering the LH surge, the mean number of follicles ≥11 mm was 25.1 ± 4.5 and the median serum oestradiol concentration was 3675 (range 2980-7670) pg/ml. After GnRH agonist injection, endogenous serum LH and FSH surges were observed with median peak values of 219 and 19 IU/l respectively, measured 4 h after injection. The mean number of oocytes obtained was 23.4 ± 15.4, of which 83% were mature (metaphase II). None of the patients developed any signs or symptoms of OHSS. So far, four clinical pregnancies have been achieved from the embryos obtained during these cycles, including the first birth following this approach. It is concluded that GnRH agonist effectively triggers an endogenous LH surge for final oocyte maturation after Ganirelix treatment in stimulated cycles. Our preliminary results suggest that this regimen may prove effective in triggering ovulation and could be said to prevent OHSS in high responders. The efficacy and safety of such new treatment regimen needs to be established in comparative randomized studies.
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treatment with the gonadotrophin releasing hormone antagonist Ganirelix in women undergoing ovarian stimulation with recombinant follicle stimulating hormone is effective safe and convenient results of a controlled randomized multicentre trial
Human Reproduction, 2000Co-Authors: G Borm, B MannaertsAbstract:A multicentre, open-label, randomized study of the gonadotrophin-releasing hormone (GnRH) antagonist Ganirelix (Orgalutran®/Antagon(TM)) was performed in women undergoing ovarian stimulation with recombinant FSH (rFSH:Puregon®). The study was designed as a non-inferiority study using a long protocol of buserelin (intranasal) and rFSH as a reference treatment. A total of 730 subjects was randomized in a treatment ratio of 2:1 (Ganirelix:buserelin) using an interactive voice response system which stratified for age, type of infertility and planned fertilization procedure [IVF or intracytoplasmic sperm injection (ICSI)]. The median duration of GnRH analogue treatment was 5 days in the Ganirelix group and 26 days in the buserelin group, whereas the median total rFSH dose was 1500 IU and 1800 IU respectively. In addition, in the Ganirelix group the mean duration of stimulation was 1 day shorter. During Ganirelix treatment the incidence of LH rises (LH ≥10 IU/l) was 2.8% versus 1.3% during rFSH stimulation in the buserelin group. On the day of triggering ovulation by human chorionic gonadotrophin (HCG), the mean number of follicles ≥11 mm diameter was 10.7 and 11.8, and the median serum oestradiol concentrations were 1190 pg/ml and 1700 pg/ml in the Ganirelix and buserelin groups respectively. The mean number of oocytes per retrieval was 9.1 and 10.4 respectively, whereas the mean number of good quality embryos was 3.3 and 3.5 respectively. The fertilization rate was equal in both groups (62.1%), and the same mean number of embryos (2.2) was replaced. The mean implantation rates were 15.7% and 21.8%, and the ongoing pregnancy rates per attempt were 20.3% and 25.7% in the Ganirelix and buserelin groups respectively. Evaluation of all safety data indicated that the Ganirelix regimen was safe and well tolerated. The overall incidence of ovarian hyperstimulation syndrome was 2.4% in the Ganirelix group and 5.9% in the reference group. The results of this study support a safe, short and convenient treatment regimen of Ganirelix, resulting in a good clinical outcome for patients undergoing ovarian stimulation for IVF or ICSI.
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Local tolerance, pharmacokinetics, and dynamics of Ganirelix (Orgalutran®) administration by Medi-Jector® compared to conventional needle injections
Human reproduction (Oxford England), 2000Co-Authors: J. Oberyé, B Mannaerts, Jan A.m Huisman, Cees J. TimmerAbstract:The feasibility of administering a relatively high dose of the gonadotrophin-releasing hormone (GnRH) antagonist Ganirelix by means of a needle-free injection device, which could be useful in the long-term treatment of sex-steroid-dependent disorders, was evaluated in a randomized, crossover study in 16 healthy females. Local tolerance and pharmacokinetics of Ganirelix administered by MediJector® versus conventional needle injections were compared. Additionally, the pharmacodynamic effect was evaluated. Two milligrams of Ganirelix was administered s.c. once daily for 7 days by Medi-Jector® or conventional needle in a randomized sequence, without a washout period. No apparent differences in local tolerance were observed. Most injections (87.5%) gave either no or only a mild reaction. Of the moderate reactions, swelling and redness were reported most frequently (overall 4.9 and 8.5% per injection, respectively). Administration by Medi-Jector® was bioequivalent to conventional needle injection with respect to the peak concentration and area under the curve. A profound suppression of luteinizing hormone and follicle stimulating hormone was observed. Serum oestradiol and progesterone concentrations were relatively low prior to treatment and remained low during the entire study period. In conclusion, administration of a relatively high dose of Ganirelix by Medi-Jector® might be useful for long-term treatment of sex-steroid dependent disorders.
Chris L. Sistrom - One of the best experts on this subject based on the ideXlab platform.
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a randomized multicenter study comparing the efficacy of recombinant fsh vs recombinant fsh with Ganirelix during superovulation iui therapy
American Journal of Obstetrics and Gynecology, 2004Co-Authors: Stan R Williams, Jessica B. Hillard, Gary De Vane, Tim Yeko, Simon Kipersztok, Alice Rhotonvlasak, Chris L. SistromAbstract:Objective The purpose of this study was to determine if use of a Gonadotropin releasing hormone (GnRH) antagonist, Ganirelix (Antagon), can improve pregnancy rates during superovulation with recombinant follicle-stimulating hormone (rFSH) followed by intrauterine insemination (IUI). Study design This was a multicenter, prospective, randomized, open-label, assessor-blind, controlled trial of females (n = 54), ages 18 to 39 undergoing superovulation/IUI with up to 4 cycles of superovulation/IUI without Ganirelix (n = 66), or up to 4 cycles of superovulation/IUI with the addition of Ganirelix (n = 52). Results No statistically significant difference in clinical pregnancy rates per cycle initiated was found for patients in the treatment or control group (12% vs 7%, P = .29). Other variables assessed, including endometrial thickness, size of follicles, peak serum estradiol levels, mid-lutea progesterone levels, and total vials of rFSH used also showed no statistically significant difference. Conclusion Superovulation/IUI cycles using Ganirelix produce similar pregnancy rates when compared with cycles not using a GnRH antagonist, although there is a trend towards better pregnancy rates in cycles with Ganirelix.
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A randomized, multicenter study comparing the efficacy of recombinant FSH vs recombinant FSH with Ganirelix during superovulation/IUI therapy.
American journal of obstetrics and gynecology, 2004Co-Authors: R. Stan Williams, Jessica B. Hillard, Gary De Vane, Tim Yeko, Simon Kipersztok, Alice Rhoton-vlasak, Chris L. SistromAbstract:Objective The purpose of this study was to determine if use of a Gonadotropin releasing hormone (GnRH) antagonist, Ganirelix (Antagon), can improve pregnancy rates during superovulation with recombinant follicle-stimulating hormone (rFSH) followed by intrauterine insemination (IUI). Study design This was a multicenter, prospective, randomized, open-label, assessor-blind, controlled trial of females (n = 54), ages 18 to 39 undergoing superovulation/IUI with up to 4 cycles of superovulation/IUI without Ganirelix (n = 66), or up to 4 cycles of superovulation/IUI with the addition of Ganirelix (n = 52). Results No statistically significant difference in clinical pregnancy rates per cycle initiated was found for patients in the treatment or control group (12% vs 7%, P = .29). Other variables assessed, including endometrial thickness, size of follicles, peak serum estradiol levels, mid-lutea progesterone levels, and total vials of rFSH used also showed no statistically significant difference. Conclusion Superovulation/IUI cycles using Ganirelix produce similar pregnancy rates when compared with cycles not using a GnRH antagonist, although there is a trend towards better pregnancy rates in cycles with Ganirelix.
William B. Schoolcraft - One of the best experts on this subject based on the ideXlab platform.
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Efficacy and safety of Ganirelix acetate versus leuprolide acetate in women undergoing controlled ovarian hyperstimulation.
Fertility and sterility, 2001Co-Authors: Margo R. Fluker, Arthur Leader, James A. Grifo, Michael J. Levy, David R. Meldrum, Suheil J. Muasher, John S. Rinehart, Zev Rosenwaks, Richard T. Scott, William B. SchoolcraftAbstract:Abstract Objective: To assess the efficacy, safety, and local tolerance of Ganirelix acetate for the inhibition of premature luteinizing hormone (LH) surges in women undergoing controlled ovarian hyperstimulation (COH). Design: Phase III, multicenter, open-label randomized trial. Setting: In vitro fertilization (IVF) centers in North America. Patient(s): Healthy female partners (n = 313) in subfertile couples for whom COH and IVF or intracytoplasmic sperm injection were indicated. Intervention(s): Patients were randomized to receive one COH cycle with Ganirelix or the reference treatment, a long protocol of leuprolide acetate in conjunction with follitropin-β for injection. Outcome Measure(s): Number of oocytes retrieved, pregnancy rates, endocrine variables, and safety variables. Result(s): The mean number of oocytes retrieved per attempt was 11.6 in the Ganirelix group and 14.1 in the leuprolide group. Fertilization rates were 62.4% and 61.9% in the Ganirelix and leuprolide groups, respectively, and implantation rates were 21.1% and 26.1%. Clinical and ongoing pregnancy rates per attempt were 35.4% and 30.8% in the Ganirelix group and 38.4% and 36.4% in the leuprolide acetate group. Fewer moderate and severe injection site reactions were reported with Ganirelix (11.9% and 0.6%) than with leuprolide (24.4% and 1.1%). Conclusion(s): Ganirelix is effective, safe, and well tolerated. Compared with leuprolide acetate, Ganirelix therapy has a shorter duration and fewer injections but produces a similar pregnancy rate.
