Luteal Support

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Mostafa Abuzeid - One of the best experts on this subject based on the ideXlab platform.

  • vaginal micronized progesterone versus intramuscular progesterone for Luteal Support in women undergoing in vitro fertilization embryo transfer
    Fertility and Sterility, 2010
    Co-Authors: Mohamed F. M. Mitwally, Michael P. Diamond, Mostafa Abuzeid
    Abstract:

    Objective To study the outcome of IVF-ET in women who used vaginal P (vaginal P 4 ) versus those who used P in oil via IM injection (IM-P 4 ) for Luteal Support. Design Retrospective cohort. Setting Tertiary referral infertility center. Patient(s) A cohort of 544 women. Intervention(s) In 145 women, vaginal P 4 was used, while in 399 women, IM-P 4 was used for Luteal Support. Main Outcome Measure(s) The primary outcome was ongoing pregnancy rate. Secondary outcomes included other IVF-ET outcomes: rates of clinical pregnancy and pregnancy loss (chemical and miscarriage) and serum P levels during the Luteal phase and early pregnancy. Result(s) Women who used vaginal P 4 for Luteal Support had ongoing pregnancy rates (odds ratio [OR], 1.0675; 95% confidence interval [CI], 0.7587–1.5020) and rates of total pregnancy loss (OR, 1.0775; 95% CI, 0.7383–1.5727) that were not statistically different from those who used IM-P 4 . During the Luteal phase, women who used vaginal P 4 had mean serum P levels that were not statistically different from those who used IM-P 4 . However, during early pregnancy, mean P levels in pregnant women who used vaginal P 4 were statistically significantly higher. Conclusion(s) In women undergoing IVF-ET according to the GnRH agonist long protocol, Luteal Support with vaginal P 4 was associated with treatment outcomes that were no different from those associated with IM-P 4 Luteal Support.

  • Vaginal micronized progesterone versus intramuscular progesterone for Luteal Support in women undergoing in vitro fertilization–embryo transfer
    Fertility and sterility, 2009
    Co-Authors: Mohamed F. M. Mitwally, Michael P. Diamond, Mostafa Abuzeid
    Abstract:

    Objective To study the outcome of IVF-ET in women who used vaginal P (vaginal P 4 ) versus those who used P in oil via IM injection (IM-P 4 ) for Luteal Support. Design Retrospective cohort. Setting Tertiary referral infertility center. Patient(s) A cohort of 544 women. Intervention(s) In 145 women, vaginal P 4 was used, while in 399 women, IM-P 4 was used for Luteal Support. Main Outcome Measure(s) The primary outcome was ongoing pregnancy rate. Secondary outcomes included other IVF-ET outcomes: rates of clinical pregnancy and pregnancy loss (chemical and miscarriage) and serum P levels during the Luteal phase and early pregnancy. Result(s) Women who used vaginal P 4 for Luteal Support had ongoing pregnancy rates (odds ratio [OR], 1.0675; 95% confidence interval [CI], 0.7587–1.5020) and rates of total pregnancy loss (OR, 1.0775; 95% CI, 0.7383–1.5727) that were not statistically different from those who used IM-P 4 . During the Luteal phase, women who used vaginal P 4 had mean serum P levels that were not statistically different from those who used IM-P 4 . However, during early pregnancy, mean P levels in pregnant women who used vaginal P 4 were statistically significantly higher. Conclusion(s) In women undergoing IVF-ET according to the GnRH agonist long protocol, Luteal Support with vaginal P 4 was associated with treatment outcomes that were no different from those associated with IM-P 4 Luteal Support.

Mohamed F. M. Mitwally - One of the best experts on this subject based on the ideXlab platform.

  • vaginal micronized progesterone versus intramuscular progesterone for Luteal Support in women undergoing in vitro fertilization embryo transfer
    Fertility and Sterility, 2010
    Co-Authors: Mohamed F. M. Mitwally, Michael P. Diamond, Mostafa Abuzeid
    Abstract:

    Objective To study the outcome of IVF-ET in women who used vaginal P (vaginal P 4 ) versus those who used P in oil via IM injection (IM-P 4 ) for Luteal Support. Design Retrospective cohort. Setting Tertiary referral infertility center. Patient(s) A cohort of 544 women. Intervention(s) In 145 women, vaginal P 4 was used, while in 399 women, IM-P 4 was used for Luteal Support. Main Outcome Measure(s) The primary outcome was ongoing pregnancy rate. Secondary outcomes included other IVF-ET outcomes: rates of clinical pregnancy and pregnancy loss (chemical and miscarriage) and serum P levels during the Luteal phase and early pregnancy. Result(s) Women who used vaginal P 4 for Luteal Support had ongoing pregnancy rates (odds ratio [OR], 1.0675; 95% confidence interval [CI], 0.7587–1.5020) and rates of total pregnancy loss (OR, 1.0775; 95% CI, 0.7383–1.5727) that were not statistically different from those who used IM-P 4 . During the Luteal phase, women who used vaginal P 4 had mean serum P levels that were not statistically different from those who used IM-P 4 . However, during early pregnancy, mean P levels in pregnant women who used vaginal P 4 were statistically significantly higher. Conclusion(s) In women undergoing IVF-ET according to the GnRH agonist long protocol, Luteal Support with vaginal P 4 was associated with treatment outcomes that were no different from those associated with IM-P 4 Luteal Support.

  • Vaginal micronized progesterone versus intramuscular progesterone for Luteal Support in women undergoing in vitro fertilization–embryo transfer
    Fertility and sterility, 2009
    Co-Authors: Mohamed F. M. Mitwally, Michael P. Diamond, Mostafa Abuzeid
    Abstract:

    Objective To study the outcome of IVF-ET in women who used vaginal P (vaginal P 4 ) versus those who used P in oil via IM injection (IM-P 4 ) for Luteal Support. Design Retrospective cohort. Setting Tertiary referral infertility center. Patient(s) A cohort of 544 women. Intervention(s) In 145 women, vaginal P 4 was used, while in 399 women, IM-P 4 was used for Luteal Support. Main Outcome Measure(s) The primary outcome was ongoing pregnancy rate. Secondary outcomes included other IVF-ET outcomes: rates of clinical pregnancy and pregnancy loss (chemical and miscarriage) and serum P levels during the Luteal phase and early pregnancy. Result(s) Women who used vaginal P 4 for Luteal Support had ongoing pregnancy rates (odds ratio [OR], 1.0675; 95% confidence interval [CI], 0.7587–1.5020) and rates of total pregnancy loss (OR, 1.0775; 95% CI, 0.7383–1.5727) that were not statistically different from those who used IM-P 4 . During the Luteal phase, women who used vaginal P 4 had mean serum P levels that were not statistically different from those who used IM-P 4 . However, during early pregnancy, mean P levels in pregnant women who used vaginal P 4 were statistically significantly higher. Conclusion(s) In women undergoing IVF-ET according to the GnRH agonist long protocol, Luteal Support with vaginal P 4 was associated with treatment outcomes that were no different from those associated with IM-P 4 Luteal Support.

Michael P. Diamond - One of the best experts on this subject based on the ideXlab platform.

  • vaginal micronized progesterone versus intramuscular progesterone for Luteal Support in women undergoing in vitro fertilization embryo transfer
    Fertility and Sterility, 2010
    Co-Authors: Mohamed F. M. Mitwally, Michael P. Diamond, Mostafa Abuzeid
    Abstract:

    Objective To study the outcome of IVF-ET in women who used vaginal P (vaginal P 4 ) versus those who used P in oil via IM injection (IM-P 4 ) for Luteal Support. Design Retrospective cohort. Setting Tertiary referral infertility center. Patient(s) A cohort of 544 women. Intervention(s) In 145 women, vaginal P 4 was used, while in 399 women, IM-P 4 was used for Luteal Support. Main Outcome Measure(s) The primary outcome was ongoing pregnancy rate. Secondary outcomes included other IVF-ET outcomes: rates of clinical pregnancy and pregnancy loss (chemical and miscarriage) and serum P levels during the Luteal phase and early pregnancy. Result(s) Women who used vaginal P 4 for Luteal Support had ongoing pregnancy rates (odds ratio [OR], 1.0675; 95% confidence interval [CI], 0.7587–1.5020) and rates of total pregnancy loss (OR, 1.0775; 95% CI, 0.7383–1.5727) that were not statistically different from those who used IM-P 4 . During the Luteal phase, women who used vaginal P 4 had mean serum P levels that were not statistically different from those who used IM-P 4 . However, during early pregnancy, mean P levels in pregnant women who used vaginal P 4 were statistically significantly higher. Conclusion(s) In women undergoing IVF-ET according to the GnRH agonist long protocol, Luteal Support with vaginal P 4 was associated with treatment outcomes that were no different from those associated with IM-P 4 Luteal Support.

  • Vaginal micronized progesterone versus intramuscular progesterone for Luteal Support in women undergoing in vitro fertilization–embryo transfer
    Fertility and sterility, 2009
    Co-Authors: Mohamed F. M. Mitwally, Michael P. Diamond, Mostafa Abuzeid
    Abstract:

    Objective To study the outcome of IVF-ET in women who used vaginal P (vaginal P 4 ) versus those who used P in oil via IM injection (IM-P 4 ) for Luteal Support. Design Retrospective cohort. Setting Tertiary referral infertility center. Patient(s) A cohort of 544 women. Intervention(s) In 145 women, vaginal P 4 was used, while in 399 women, IM-P 4 was used for Luteal Support. Main Outcome Measure(s) The primary outcome was ongoing pregnancy rate. Secondary outcomes included other IVF-ET outcomes: rates of clinical pregnancy and pregnancy loss (chemical and miscarriage) and serum P levels during the Luteal phase and early pregnancy. Result(s) Women who used vaginal P 4 for Luteal Support had ongoing pregnancy rates (odds ratio [OR], 1.0675; 95% confidence interval [CI], 0.7587–1.5020) and rates of total pregnancy loss (OR, 1.0775; 95% CI, 0.7383–1.5727) that were not statistically different from those who used IM-P 4 . During the Luteal phase, women who used vaginal P 4 had mean serum P levels that were not statistically different from those who used IM-P 4 . However, during early pregnancy, mean P levels in pregnant women who used vaginal P 4 were statistically significantly higher. Conclusion(s) In women undergoing IVF-ET according to the GnRH agonist long protocol, Luteal Support with vaginal P 4 was associated with treatment outcomes that were no different from those associated with IM-P 4 Luteal Support.

Micah J. Hill - One of the best experts on this subject based on the ideXlab platform.

  • Progesterone Luteal Support after ovulation induction and intrauterine insemination: an updated systematic review and meta-analysis.
    Fertility and sterility, 2017
    Co-Authors: Katherine A Green, Nancy Terry, Alan H. Decherney, Terrence D Lewis, Jessica R Zolton, Sophia M V Schermerhorn, Mae W Healy, Micah J. Hill
    Abstract:

    To evaluate the effect of progesterone (P) for Luteal phase Support after ovulation induction (OI) and intrauterine insemination (IUI). An updated systematic review and meta-analysis. Not applicable. Patients undergoing OI-IUI for infertility. Exogenous P Luteal Support after OI-IUI. Live birth. Eleven trials were identified that met inclusion criteria and constituted 2,842 patients undergoing 4,065 cycles, more than doubling the sample size from the previous meta-analysis. In patients receiving gonadotropins for OI, clinical pregnancy (relative risk [RR] 1.56, 95% confidence interval [CI] 1.21-2.02) and live birth (RR 1.77, 95% CI 1.30-2.42) were more likely in P supplemented patients. These findings persisted in analysis of live birth per IUI cycle (RR 1.59, 95% CI 1.24-2.04). There were no data on live birth in clomiphene citrate or clomiphene plus gonadotropin cycles. There was no benefit on clinical pregnancy with P Support for patients who underwent OI with clomiphene (RR 0.85, 95% CI 0.52-1.41) or clomiphene plus gonadotropins (RR 1.26, 95% CI 0.90-1.76). Progesterone Luteal phase Support is beneficial to patients undergoing ovulation induction with gonadotropins in IUI cycles. The number needed to treat is 11 patients to have one additional live birth. Progesterone Support did not benefit patients undergoing ovulation induction with clomiphene citrate or clomiphene plus gonadotropins. Published by Elsevier Inc.

  • Timing Luteal Support in assisted reproductive technology: a systematic review
    Fertility and sterility, 2015
    Co-Authors: Matthew T. Connell, Jennifer M. Szatkowski, Nancy Terry, Alan H. Decherney, Anthony M. Propst, Micah J. Hill
    Abstract:

    Objective To summarize the available published randomized controlled trial data regarding timing of P supplementation during the Luteal phase of patients undergoing assisted reproductive technology (ART). Design A systematic review. Setting Not applicable. Patient(s) Undergoing IVF. Intervention(s) Different starting times of P for Luteal Support. Main Outcome Measure(s) Clinical pregnancy (PR) and live birth rates. Result(s) Five randomized controlled trials were identified that met inclusion criteria with a total of 872 patients. A planned meta-analysis was not performed because of a high degree of clinical heterogeneity with regard to the timing, dose, and route of P. Two studies compared P initiated before oocyte retrieval versus the day of oocyte retrieval and PRs were 5%–12% higher when starting P on the day of oocyte retrieval. One study compared starting P on day 6 after retrieval versus day 3, reporting a 16% decrease in pregnancy in the day 6 group. Trials comparing P start times on the day of oocyte retrieval versus 2 or 3 days after retrieval showed no significant differences in pregnancy. Conclusion(s) There appears to be a window for P start time between the evening of oocyte retrieval and day 3 after oocyte retrieval. Although some studies have suggested a potential benefit in delaying vaginal P start time to 2 days after oocyte retrieval, this review could not find randomized controlled trials to adequately assess this. Further randomized clinical trials are needed to better define P start time for Luteal Support after ART.

  • progesterone Luteal Support after ovulation induction and intrauterine insemination a systematic review and meta analysis
    Fertility and Sterility, 2013
    Co-Authors: Micah J. Hill, Nancy Terry, Alan H. Decherney, Brian W Whitcomb, Terrence D Lewis, Mae Wu, Eric D Levens, A M Propst
    Abstract:

    Objective To evaluate the effect of progesterone (P) for Luteal phase Support after ovulation induction (OI) and intrauterine insemination (IUI). Design An updated systematic review and meta-analysis. Setting Not applicable. Patient(s) Patients undergoing OI-IUI for infertility. Intervention(s) Exogenous P Luteal Support after OI-IUI. Main Outcome Measure(s) Live birth. Result(s) Eleven trials were identified that met inclusion criteria and constituted 2,842 patients undergoing 4,065 cycles, more than doubling the sample size from the previous meta-analysis. In patients receiving gonadotropins for OI, clinical pregnancy (relative risk [RR] 1.56, 95% confidence interval [CI] 1.21–2.02) and live birth (RR 1.77, 95% CI 1.30–2.42) were more likely in P supplemented patients. These findings persisted in analysis of live birth per IUI cycle (RR 1.59, 95% CI 1.24–2.04). There were no data on live birth in clomiphene citrate or clomiphene plus gonadotropin cycles. There was no benefit on clinical pregnancy with P Support for patients who underwent OI with clomiphene (RR 0.85, 95% CI 0.52–1.41) or clomiphene plus gonadotropins (RR 1.26, 95% CI 0.90–1.76). Conclusion(s) Progesterone Luteal phase Support is beneficial to patients undergoing ovulation induction with gonadotropins in IUI cycles. The number needed to treat is 11 patients to have one additional live birth. Progesterone Support did not benefit patients undergoing ovulation induction with clomiphene citrate or clomiphene plus gonadotropins.

Georg Griesinger - One of the best experts on this subject based on the ideXlab platform.

  • A Phase III randomized controlled trial of oral dydrogesterone versus intravaginal progesterone gel for Luteal phase Support in in vitro fertilization (Lotus II): results from the Chinese mainland subpopulation
    Gynecological endocrinology : the official journal of the International Society of Gynecological Endocrinology, 2019
    Co-Authors: Dongzi Yang, Fei Gong, Elke Kahler, Georg Griesinger, Wei Wang, Xiaoyan Liang, Hanwang Zhang, Yingpu Sun, Claire Pexman-fieth, Jan I. Olofsson
    Abstract:

    Lotus II, a randomized, open-label, multicenter, international study compared the efficacy and safety of oral dydrogesterone versus micronized vaginal progesterone (MVP) gel for Luteal Support in I...

  • a phase iii randomized controlled trial comparing the efficacy safety and tolerability of oral dydrogesterone versus micronized vaginal progesterone for Luteal Support in in vitro fertilization
    Human Reproduction, 2017
    Co-Authors: Herman Tournaye, Gennady T. Sukhikh, Elke Kahler, Georg Griesinger
    Abstract:

    STUDY QUESTION Is oral dydrogesterone 30 mg daily (10 mg three times daily [TID]) non-inferior to micronized vaginal progesterone (MVP) 600 mg daily (200 mg TID) for Luteal Support in in vitro fertilization (IVF), assessed by the presence of fetal heartbeats determined by transvaginal ultrasound at 12 weeks of gestation? SUMMARY ANSWER Non-inferiority of oral dydrogesterone versus MVP was demonstrated at 12 weeks of gestation, with a difference in pregnancy rate and an associated confidence interval (CI) that were both within the non-inferiority margin. WHAT IS KNOWN ALREADY MVP is routinely used in most clinics for Luteal Support in IVF, but it is associated with side effects, such as vaginal irritation and discharge, as well as poor patient acceptance. Dydrogesterone may be an alternative treatment due to its patient-friendly oral administration. STUDY DESIGN, SIZE, DURATION Lotus I was an international Phase III randomized controlled trial, performed across 38 sites, from August 2013 to March 2016. Subjects were premenopausal women (>18 to <42 years of age; body mass index (BMI) ≥18 to ≤30 kg/m2) with a documented history of infertility who were planning to undergo IVF. A centralized electronic system was used for randomization, and the study investigators, sponsor's study team, and subjects remained blinded throughout the study. PARTICIPANTS/MATERIALS, SETTING, METHODS In total, 1031 subjects were randomized to receive either oral dydrogesterone (n = 520) or MVP (n = 511). Luteal Support was started on the day of oocyte retrieval and continued until 12 weeks of gestation (Week 10), if a positive pregnancy test was obtained at 2 weeks after embryo transfer. MAIN RESULTS AND THE ROLE OF CHANCE In the full analysis set (FAS), 497 and 477 subjects in the oral dydrogesterone and MVP groups, respectively, had an embryo transfer. Non-inferiority of oral dydrogesterone was demonstrated, with pregnancy rates at 12 weeks of gestation of 37.6% and 33.1% in the oral dydrogesterone and MVP treatment groups, respectively (difference 4.7%; 95% CI: -1.2-10.6%). Live birth rates of 34.6% (172 mothers with 213 newborns) and 29.8% (142 mothers with 158 newborns) were obtained in the dydrogesterone and MVP groups, respectively (difference 4.9%; 95% CI: -0.8-10.7%). Oral dydrogesterone was well tolerated and had a similar safety profile to MVP. LIMITATIONS, REASONS FOR CAUTION The analysis of the results was powered to consider the clinical pregnancy rate, but the live birth rate may be of greater clinical interest. Conclusions relating to the differences between treatments in live birth rate, observed in this study, should therefore be made with caution. WIDER IMPLICATIONS OF THE FINDINGS Oral dydrogesterone may replace MVP as the standard of care for Luteal phase Support in IVF, owing to the oral route being more patient-friendly than intravaginal administration, as well as it being a well tolerated and efficacious treatment. STUDY FUNDING/COMPETING INTEREST(S) Sponsored and Supported by Abbott Established Pharmaceuticals Division. H.T.'s institution has received grants from Merck, MSD, Goodlife, Cook, Roche, Besins, Ferring and Mithra (now Allergan) and H.T. has received consultancy fees from Finox, Ferring, Abbott, ObsEva and Ovascience. G.S. has nothing to disclose. E.K. is an employee of Abbott GmbH. G.G. has received investigator fees from Abbott during the conduct of the study; outside of this submitted work, G.G. has received personal fees and non-financial Support from MSD, Ferring, Merck-Serono, Finox, TEVA, Glycotope, as well as personal fees from VitroLife, NMC Healthcare LLC, ReprodWissen LLC and ZIVA LLC. TRIAL REGISTRATION NUMBER NCT01850030 (clinicaltrials.gov). TRIAL REGISTRATION DATE 19 April 2013. DATE OF FIRST PATIENT'S ENROLLMENT 23 August 2013.

  • A Phase III randomized controlled trial comparing the efficacy, safety and tolerability of oral dydrogesterone versus micronized vaginal progesterone for Luteal Support in in vitro fertilization.
    Human reproduction (Oxford England), 2017
    Co-Authors: Herman Tournaye, Gennady T. Sukhikh, Elke Kahler, Georg Griesinger
    Abstract:

    STUDY QUESTION Is oral dydrogesterone 30 mg daily (10 mg three times daily [TID]) non-inferior to micronized vaginal progesterone (MVP) 600 mg daily (200 mg TID) for Luteal Support in in vitro fertilization (IVF), assessed by the presence of fetal heartbeats determined by transvaginal ultrasound at 12 weeks of gestation? SUMMARY ANSWER Non-inferiority of oral dydrogesterone versus MVP was demonstrated at 12 weeks of gestation, with a difference in pregnancy rate and an associated confidence interval (CI) that were both within the non-inferiority margin. WHAT IS KNOWN ALREADY MVP is routinely used in most clinics for Luteal Support in IVF, but it is associated with side effects, such as vaginal irritation and discharge, as well as poor patient acceptance. Dydrogesterone may be an alternative treatment due to its patient-friendly oral administration. STUDY DESIGN, SIZE, DURATION Lotus I was an international Phase III randomized controlled trial, performed across 38 sites, from August 2013 to March 2016. Subjects were premenopausal women (>18 to