Vaginal (Crinone 8%) gel vs. intramuscular progesterone in oil for luteal phase support in in vitro fertilization: a large prospective trial

Silverberg, Kaylen M.; Vaughn, T.C.; Hansard, L.J.; Burger, Natalie Z.; Minter, T.

doi:10.1016/j.fertnstert.2011.11.018

Cited by 50 publications

(29 citation statements)

References 22 publications

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“…Indeed, several observational studies have suggested that there is no difference in efficacy between i.m. and vaginal progesterone (Khan et al , 2009; Mitwally et al , 2010; Silverberg et al , 2012). A recent survey did, however, reveal geographic differences in the utilization of various routes of progesterone administration (Vaisbuch et al , 2012); worldwide, nearly two-third of IVF cycles utilize vaginal progesterone, whereas in North America, IM progesterone is utilized alone or with vaginal progesterone in 57% of cycles.…”

Section: Discussionmentioning

confidence: 99%

“…Part of this uncertainty is owing to the fact that the timing and duration of implantation are not precisely known (Paulson, 2011). In other studies, progesterone has been initiated on the day of retrieval in some or all patients (Baruffi et al , 2003; Mochtar et al , 2006), the day after retrieval (Doody et al , 2009; Yanushpolsky et al , 2010; Stadtmauer et al , 2013) or 2 days after retrieval (Silverberg et al , 2012), without an obvious impact on treatment effect. In our study, the first dose of subcutaneous progesterone was administered on the day of (but immediately after) oocyte retrieval, so that the administration could be performed under the supervision of a healthcare provider and the injection site could be observed to ensure that the subject did not experience a significant allergic reaction.…”

Section: Discussionmentioning

confidence: 99%

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A randomized, controlled trial comparing the efficacy and safety of aqueous subcutaneous progesterone with vaginal progesterone for luteal phase support of in vitro fertilization

Baker

Jones²,

Doody

et al. 2014

Human Reproduction

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STUDY QUESTIONIs the ongoing pregnancy rate with a new aqueous formulation of subcutaneous progesterone (Prolutex®) non-inferior to vaginal progesterone (Endometrin®) when used for luteal phase support of in vitro fertilization?SUMMARY ANSWERIn 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) −9.7, 4.2), consistent with the non-inferiority of subcutaneous progesterone for luteal phase support.WHAT IS KNOWN ALREADYLuteal phase support has been clearly demonstrated to improve pregnancy rates in women undergoing in vitro fertilization (IVF). Because of the increased risk of ovarian hyperstimulation syndrome associated with the use of hCG, progesterone has become the treatment of choice for luteal phase support.STUDY DESIGN, SIZE, DURATIONThis prospective, open-label, randomized, controlled, parallel-group, multicentre, two-arm, non-inferiority study was performed at eight fertility clinics. A total of 800 women, aged 18–42 years, with a BMI of ≤30 kg/m2, with <3 prior completed assisted reproductive technology (ART) cycles, exhibiting baseline (Days 2–3) FSH of ≤15 IU/L and undergoing IVF at 8 centres (seven private, one academic) in the USA, were enrolled from January 2009 through June 2011.PARTICIPANTS/MATERIALS, SETTING, METHODSIn total, 800 women undergoing IVF were randomized after retrieval of at least three oocytes to an aqueous preparation of progesterone administered subcutaneously (25 mg daily) or vaginal progesterone (100 mg bid daily). Randomization was performed to enrol 100 patients at each site using a randomization list that was generated with Statistical Analysis Software (SAS®). If a viable pregnancy occurred, progesterone treatment was continued up to 12 weeks of gestation.MAIN RESULTS AND THE ROLE OF CHANCEUsing a PP analysis, which included all patients who received an embryo transfer (Prolutex = 392; Endometrin = 390), the ongoing pregnancy rate per retrieval for subcutaneous versus vaginal progesterone was 41.6 versus 44.4%, with a difference between groups of −2.8% (95% CI −9.7, 4.2), consistent with the non-inferiority of subcutaneous progesterone for luteal phase support. In addition, rates of initial positive β-hCG (56.4% subcutaneous versus 59.0% vaginal; 95% CI −9.5, 4.3), clinical intrauterine pregnancy with fetal cardiac activity (42.6 versus 46.4%; 95% CI −10.8, 3.2), implantation defined as number of gestational sacs divided by number of embryos transferred (33.2 versus 35.1%; 95% CI −7.6, 4.0), live birth (41.1 versus 43.1%; 95% CI −8.9, 4.9) and take-home baby (41.1 versus 42.6%; 95% CI −8.4, 5.4) were comparable. Both formulations were well-tolerated, with no difference in serious adverse events. Analysis with the intention-to-treat population also demonstrated no difference for any outcomes between the treatment groups.LIMITATIONS, REASONS FOR CAUTIONThe conclusions are limited to th...

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Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

A randomized, controlled trial comparing the efficacy and safety of aqueous subcutaneous progesterone with vaginal progesterone for luteal phase support of in vitro fertilization

Baker

Jones²,

Doody

et al. 2014

Human Reproduction

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show abstract

“…A recent randomized controlled trial comparing the efficacy of subcutaneous and vaginal progesterone forms reported that positive β-hCG, clinical pregnancy and take-home baby rates were comparable between the groups [22]. In a prospective study by Silverberg et al [23], live birth rates were reported to be higher in the vaginal progesterone group than in intramuscular progesterone arm. Dose-related studies on progesterone have remained limited in number and the question whether utilization of different doses of progesterone fosters a significant effect on clinical pregnancy rates has not yet been fully clarified [3].…”

Section: Discussionmentioning

confidence: 98%

Progesterone vaginal capsule versus vaginal gel for luteal support in normoresponder women undergoing long agonist IVF/ICSI cycles

Gün

Özdamar²,

Şahin³

et al. 2016

Ginekol Pol

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Objectives: The aim of the study was to investigate the effects of two different vaginal progesterone forms, administered for luteal phase support, on pregnancy outcomes in normoresponder women aged < 35, who underwent long agonist IVF/ICSI-ET cycles. Material and methods:A retrospective cohort analysis was designed. Normoresponders with primary infertility, who underwent IVF/ICSI-ET cycles employing GnRH analogue and who received progesterone as either capsule or gel form for LPS following a single embryo transfer, were analyzed. The cycles were categorized into two groups: micronized progesterone vaginal capsule 600 mg/day (Group 1, n = 78) and progesterone vaginal gel 180 mg/day (Group 2, n = 99). Positive β-hCG, clinical pregnancy and ongoing pregnancy rates were analyzed.Results: Both, demographic and stimulation characteristics were comparable between the groups. No difference was observed between the capsule and the gel groups regarding positive β-hCG (33.3% and 28.3%, respectively; p = 0.580), clinical pregnancy (26.9% and 22.2%, respectively; p = 0.584), and ongoing pregnancy rates (21.8% and 20.2%, respectively; p = 0.942) after treatment completion. Conclusions:In long agonist IVF/ICSI-ET cycles, positive β-hCG, clinical pregnancy and ongoing pregnancy rates do not significantly differ between normoresponder patients receiving micronized progesterone vaginal capsule and those receiving progesterone vaginal gel for LPS.

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“…325 Randomized trials using vaginal progesterone administered in a polycarbophil gel preparation suggest equivalent pregnancy rates to intramuscular progesterone 317 with one study showing superiority of vaginal gel in young patients. 326 Meta-analyses have not found any difference in delivery rates between different vaginal progesterone preparations including vaginal micronized progesterone suppositories, 327 or between vaginal preparations and intramuscular progesterone. 328 Another controversy regarding luteal phase support concerns estrogen.…”

Section: Luteal Phase Support In Fresh Embryo Transfersmentioning

confidence: 99%

Assisted Reproduction

Ginsburg¹,

Racowsky²

2014

Yen &Amp; Jaffe's Reproductive Endocrinology

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Vaginal (Crinone 8%) gel vs. intramuscular progesterone in oil for luteal phase support in in vitro fertilization: a large prospective trial

Cited by 50 publications

References 22 publications

A randomized, controlled trial comparing the efficacy and safety of aqueous subcutaneous progesterone with vaginal progesterone for luteal phase support of in vitro fertilization

A randomized, controlled trial comparing the efficacy and safety of aqueous subcutaneous progesterone with vaginal progesterone for luteal phase support of in vitro fertilization

Progesterone vaginal capsule versus vaginal gel for luteal support in normoresponder women undergoing long agonist IVF/ICSI cycles

Assisted Reproduction

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