Endometrin for luteal phase support in a randomized, controlled, open-label, prospective in-vitro fertilization trial using a combination of Menopur and Bravelle for controlled ovarian hyperstimulation.

  title={Endometrin for luteal phase support in a randomized, controlled, open-label, prospective in-vitro fertilization trial using a combination of Menopur and Bravelle for controlled ovarian hyperstimulation.},
  author={K. Doody and V. Schnell and R. Foulk and Charles E. Miller and B. Kolb and E. J. Blake and V. Yankov},
  journal={Fertility and sterility},
  volume={91 4},
OBJECTIVE To assess the efficacy and safety of a vaginal progesterone (P(4)) insert (Endometrin) for luteal support for assisted reproductive technology (ART). DESIGN Multicenter, randomized, open-label (assessor-blinded) phase III clinical trial. SETTING Twenty-five U.S. ART centers. PATIENT(S) A total of 1,211 ART patients randomized to three groups: Endometrin 100 mg twice daily (n = 404), Endometrin 100 mg three times daily (n = 404), and P(4) 90 mg 8% gel daily (n = 403… Expand
Progesterone vaginal ring versus vaginal gel for luteal support with in vitro fertilization: a randomized comparative study.
A randomized, single-blind, multicenter, phase III clinical trial to compare the efficacy and safety of luteal phase support in IVF with a progesterone vaginal ring or gel with no major differences in safety. Expand
A randomized, controlled trial comparing the efficacy and safety of aqueous subcutaneous progesterone with vaginal progesterone for luteal phase support of in vitro fertilization
In the per-protocol (PP) population, the ongoing pregnancy rates per oocyte retrieval at 12 weeks of gestation were comparable between Prolutex and Endometrin (41.6 versus 44.4%), with a difference between groups of −2.8% (95% confidence interval (CI) −9.8%) consistent with the non-inferiority of subcutaneous progesterone for luteal phase support. Expand
A multi‐center, randomized, open‐label, parallel group study of a natural micronized progesterone vaginal tablet as a luteal support agent in Japanese women undergoing assisted reproductive technology
  • T. Fujiwara
  • Medicine
  • Reproductive medicine and biology
  • 2015
FE 999913 was useful in this trial from the aspects of sufficient supplementation of progesterone, comparable pregnancy rate with that in clinical practice in Japan, and safety. Expand
A meta-analysis of the route of administration of luteal phase support in assisted reproductive technology: vaginal versus intramuscular progesterone.
Meta-analysis of progesterone luteal support in IVF cycles using odds ratios (OR) and 95% confidence intervals (CI) showed a comparable effect between vaginal P as an oil-in-capsule or as a bioadhesive gel and IM P administration on the endpoints of clinical pregnancy and ongoing pregnancy. Expand
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
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. Expand
Subcutaneous Progesterone Is Effective and Safe for Luteal Phase Support in IVF: An Individual Patient Data Meta-Analysis of the Phase III Trials
No statistical significant or clinical significant differences exist between subcutaneous and vaginal progesterone for luteal phase support in patients undergoing IVF treatment. Expand
Pilot study evaluating a progesterone vaginal ring for luteal-phase replacement in donor oocyte recipients.
In women requiring luteal-phase replacement, the P vaginal ring was able to adequately transform the endometrium and was comparable to the P vagina gel in efficacy and safety, while offering the advantage of weekly rather than multiple daily doses. Expand
Intramuscular progesterone (Gestone) versus vaginal progesterone suppository (Cyclogest) for luteal phase support in cycles of in vitro fertilization–embryo transfer: patient preference and drug efficacy
Patients’ satisfaction and pregnancy rates were similar between vaginal and IM P supplementation, and there were no statistically significant differences in the patients’ characteristics and clinical outcomes between the two groups. Expand
Timing luteal support in assisted reproductive technology: a systematic review.
There appears to be a window for P start time between the evening of oocyte retrieval and day 3 after oocytes retrieval, and although some studies have suggested a potential benefit in delaying vaginal P startTime to 2 days after oocyte retrieved, this review could not find randomized controlled trials to adequately assess this. Expand
Endometrin as luteal phase support in assisted reproduction.
Endometrin monotherapy was sufficient for the P component of luteal support and provided high PRs for fresh cycles in both autologous and donor oocyte cycles in assisted reproductive technology (ART) cycles. Expand


The role of luteal phase support in infertility treatment: a meta-analysis of randomized trials.
The meta-analysis supports the routine use of hCG in IVF cycles using a GnRH-a and Progesterone was also beneficial for luteal phase support in IVf, however, for other infertility therapy, further research is needed. Expand
Luteal phase support in infertility treatment: a meta-analysis of the randomized trials.
i.m. progesterone is favoured for luteal phase supplementation with the addition of estrogen in women undergoing IVF cycles, given the increased risk of ovarian hyperstimulation syndrome associated with hCG use. Expand
Female reproductive aging — Ovarian and uterine factors
Oocyte donation, through the use of oocytes from young normal women and an increased level of P replacement to aging recipients, corrects both of these defects of oocyte quality and uterine receptivity. Expand
Pharmacokinetics of natural progesterone administered in the form of a vaginal tablet.
Natural progesterone given as a vaginal tablet is well tolerated, safe and an easily administered treatment and even in a non-oestrogenized vagina the absorption was efficient and the 100 mg dosage resulted in adequate serum progestersone concentrations. Expand
Targeted drug delivery in gynaecology: the first uterine pass effect.
The data demonstrate that a 'first uterine pass effect' occurs when drugs are delivered vaginally, thereby providing an explanation for the unexpectedly high uterine concentrations relative to the low serum concentration observed after vaginal administration. Expand
Investigation of Product Quality Between Extemporaneously Compounded Progesterone Vaginal Suppositories and an Approved Progesterone Vaginal Gel
Data indicates that pharmacy compounded delivery systems for progesterone should be used with caution and the content uniformity and pH of most of the compounded suppository products was in the range of 4.22 to 7.68, whereas the gel product was 2.80. Expand
Luteal Phase Support
Single day and multiple day pharmacokinetics of a novel vaginal micronized progesterone tablet (Endometrin) compared to Crinone vaginal gel in healthy female subjects
  • Reprod Sci 2007;14(Suppl):198A
  • 2007