Vitrified blastocyst transfer cycles with the use of only vaginal progesterone replacement with Endometrin have inferior ongoing pregnancy rates: results from the planned interim analysis of a three-arm randomized controlled noninferiority trial

Devine, Kate; Richter, Kevin S.; Widra, E.A.; McKeeby, Jeffrey

doi:10.1016/j.fertnstert.2017.11.004

Cited by 117 publications

(78 citation statements)

References 56 publications

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“…In earlier trials, IM and vaginal P were found to be equivalent for priming endometrial receptivity in E 2 and P cycles used in FET (45). A more recent report challenged these views, however, with higher miscarriage rates reported in the vaginal P group (46). The practicalities of hormonal treatments for FETs are discussed in a different article of this series.…”

Section: The Donor Egg Settingmentioning

confidence: 87%

Role of gonadotropin-releasing hormone agonists, human chorionic gonadotropin (hCG), progesterone, and estrogen in luteal phase support after hCG triggering, and when in pregnancy hormonal support can be stopped

Ziegler

Pirtea

Andersen

et al. 2018

Fertility and Sterility

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Luteal phase support is mandatory in ovarian stimulation cycles in assisted reproductive technology owing to a deficit in LH pulsatility after the effects of exogenous hCG-used for triggering ovulation-vanish. This is classically accomplished by means of exogenous P administration, but emerging new options include microdoses of hCG and exogenous GnRH agonist. Although luteal phase support is commonly continued for up to 10 weeks into pregnancy, there is accumulating evidence that it can be stopped after the first ultrasound or even after a positive pregnancy test.

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Section: The Donor Egg Settingmentioning

confidence: 87%

Role of gonadotropin-releasing hormone agonists, human chorionic gonadotropin (hCG), progesterone, and estrogen in luteal phase support after hCG triggering, and when in pregnancy hormonal support can be stopped

Ziegler

Pirtea

Andersen

et al. 2018

Fertility and Sterility

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“…Each patient will receive a course of combined oral contraceptive pills followed by oral estradiol (6 mg daily), which is started on day 2 of the withdrawal bleed. We will administer intra-muscular progesterone with or without vaginal progesterone for luteal support in thaw cycles after the endometrial lining reaches a minimal trilaminar endometrial thickness of 7 mm (day 1) with embryo transfer in the afternoon of day 6 [15]. No drugs or new devices will be examined as part of this study.…”

Section: Study Design and Settingmentioning

confidence: 99%

Non-inferiority of cleavage-stage versus blastocyst-stage embryo transfer in poor prognosis IVF patients (PRECiSE trial): study protocol for a randomized controlled trial

et al. 2020

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Background: With improvements in in vitro culture techniques there has been a steady shift in practice to transfer embryos at the blastocyst stage (post fertilization day (p.f.d.) 5-7), when embryos reach the endometrial cavity during natural conception. For patients with > 5 zygotes on day 1 of embryo development, fresh blastocyst embryo transfer (ET) increases live birth rates when compared to cleavage stage (p.f.d. 3) transfer. In poorer prognosis patients (≤ 5 zygotes) cleavage stage ET is commonly performed to reduce the risk of cycle cancellation if no embryo survives to the blastocyst stage. However, there is a dearth of randomized controlled trial (RCT) data demonstrating improved live birth rates per cycle for cleavage vs blastocyst stage ET in this subgroup of patients. The hypothesis of the PRECiSE (PooR Embryo Yield Cleavage Stage Versus blaStocyst Embryo Transfer) trial is that blastocyst ET is not inferior to cleavage stage ET with regard to live birth rates per retrieval in poorer prognosis patients. The adoption of routine blastocyst culture for all patients would result in higher rates of single embryo transfers (SET), reduced incidence of multiple pregnancies and simplified laboratory protocols, thereby reducing costs.Methods/design: Multicenter, non-inferiority randomized controlled trial (RCT) comparing blastocyst to cleavage stage embryo transfer in poorer prognosis patients with ≤5 zygotes on day 1 after fertilization. The primary outcome is live birth per retrieval. Secondary outcomes include: time to pregnancy, clinical pregnancy, ongoing pregnancy, miscarriage and multiple pregnancy rate (per retrieval). This trial will enroll 658 women with ≤5 zygotes on day 1 at 6 IVF centers over the course of 22 months.Discussion: If the hypothesis is proven true, the data from this trial may facilitate the adoption of uniform blastocyst culture in all IVF patients.

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“…While extensive research has evaluated ideal protocols for endometrial preparation, no definitive method has been established [10][11][12]. The optimal route of progesterone or estradiol administration [13][14][15] and duration of progesterone administration [16,17] have all been studied. While intramuscular progesterone has been shown to be superior to Endometrin for ongoing pregnancy rate in an interim analysis of a large randomized non-inferiority study [15], significant differences in implantation, clinical pregnancy and live birth rates were not observed in a retrospective evaluation comparing vaginal progesterone gel to intramuscular progesterone [14].…”

Section: Introductionmentioning

confidence: 99%

Measuring serum estradiol and progesterone one day prior to frozen embryo transfer improves live birth rates

Alur-Gupta

Hopeman

Berger

et al. 2020

Fertil Res and Pract

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Background: Given no consensus in the literature, this study sought to determine if a protocol of measuring serum estradiol and progesterone the day prior to frozen embryo transfer (FET) improves likelihood of pregnancy and livebirth. Methods: This was a retrospective time-series study of women undergoing autologous vitrified-warmed blastocyst programmed FETs at an academic institution. Live birth rates were compared between a surveillance protocol, where serum estrogen and progesterone surveillance are performed the day prior to a programmed FET, and a standard protocol, whereby no hormonal lab evaluation is performed the day prior. Results: Three hundred seventy-nine standard FET and 524 surveillance FET cycles were performed. Patients in the surveillance protocol were significantly more likely to achieve live birth (51% vs. 39%; aOR 1.6, 95%CI [1.2, 2.2]). Obese women were noted to be more likely to have lower progesterone hormone levels on surveillance labs (OR 3.2, 95%CI [2.0, 5.3]). However those whose hormonal medication dose was modified because of pre-transfer labs were as likely to achieve live birth as those whose dose was not modified (47% vs. 53%; aOR 0.8, 95%CI [0.6, 1.2]). Conclusions: Cycles with the surveillance protocol were more likely to result in live birth. Patients with low levels of pre-transfer hormones, such as obese patients, likely have lower pregnancy rates. It is possible that when these levels were corrected after measurement, pregnancy rates improved to match those whose levels were not low enough to warrant intervention.

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Vitrified blastocyst transfer cycles with the use of only vaginal progesterone replacement with Endometrin have inferior ongoing pregnancy rates: results from the planned interim analysis of a three-arm randomized controlled noninferiority trial

Abstract: NLM identifier NCT02254577.

Cited by 117 publications

References 56 publications

Role of gonadotropin-releasing hormone agonists, human chorionic gonadotropin (hCG), progesterone, and estrogen in luteal phase support after hCG triggering, and when in pregnancy hormonal support can be stopped

Role of gonadotropin-releasing hormone agonists, human chorionic gonadotropin (hCG), progesterone, and estrogen in luteal phase support after hCG triggering, and when in pregnancy hormonal support can be stopped

Non-inferiority of cleavage-stage versus blastocyst-stage embryo transfer in poor prognosis IVF patients (PRECiSE trial): study protocol for a randomized controlled trial

Measuring serum estradiol and progesterone one day prior to frozen embryo transfer improves live birth rates

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