A randomized controlled trial of vaginal progesterone for luteal phase support in modified natural cycle – frozen embryo transfer

Horowitz, Eran; Mizrachi, Yossi; Finkelstein, Maya; Farhi, Jacob; Shalev, Amir; Gold, Eran; Raziel, Arieh; Weissman, Ariel

doi:10.1080/09513590.2020.1854717

Cited by 16 publications

(9 citation statements)

References 31 publications

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“…Since hCG has a long half-life and a sustained luteotropic effect during the early luteal phase up to 7 days following administration (85), LPS might not be needed in modified-NC (86,87). In line with this two RCTs (87,88), two retrospective studies report comparable reproductive outcomes with or without LPS in modified-NC (89,90).…”

Section: Is Lps Needed In T-nc or Modified-nc?supporting

confidence: 74%

Preparation of the Endometrium for Frozen Embryo Transfer: A Systematic Review

et al. 2021

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Despite the worldwide increase in frozen embryo transfer, the search for the best protocol to prime endometrium continues. Well-designed trials comparing various frozen embryo transfer protocols in terms of live birth rates, maternal, obstetric and neonatal outcome are urgently required. Currently, low-quality evidence indicates that, natural cycle, either true natural cycle or modified natural cycle, is superior to hormone replacement treatment protocol. Regarding warmed blastocyst transfer and frozen embryo transfer timing, the evidence suggests the 6th day of progesterone start, LH surge+6 day and hCG+7 day in hormone replacement treatment, true natural cycle and modified natural cycle protocols, respectively. Time corrections, due to inter-personal differences in the window of implantation or day of vitrification (day 5 or 6), should be explored further. Recently available evidence clearly indicates that, in hormone replacement treatment and natural cycles, there might be marked inter-personal variation in serum progesterone levels with an impact on reproductive outcomes, despite the use of the same dose and route of progesterone administration. The place of progesterone rescue protocols in patients with low serum progesterone levels one day prior to warmed blastocyst transfer in hormone replacement treatment and natural cycles is likely to be intensively explored in near future.

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Section: Is Lps Needed In T-nc or Modified-nc?supporting

confidence: 74%

Preparation of the Endometrium for Frozen Embryo Transfer: A Systematic Review

et al. 2021

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“… 27 Further, a small study from Israel, including only 59 patients, using a modified NC-FET protocol, also found a significantly higher LBR after LPS compared with no progesterone. 28 The study included a mix of cleavage stage embryos and blastocysts and up to three embryos were transferred.…”

Section: Discussionmentioning

confidence: 99%

Vaginal progesterone as luteal phase support in natural cycle frozen-thawed embryo transfer (ProFET): protocol for a multicentre, open-label, randomised controlled trial

et al. 2022

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IntroductionVaginal progesterone supplementation is frequently given to patients receiving frozen embryo transfer (FET) in the natural cycle aiming to increase the chance of pregnancy and live birth. To date, only a few studies have investigated if progesterone supplementation is beneficial in these cycles and the level of evidence for progesterone supplementation is very low.Methods and analysisThe ProFET trial is a multicentre, open-label, randomised controlled trial powered for this investigation, including 1800 women with regular menstrual cycles (24–35 days), aged 18–43 years planned for natural cycle-FET receiving a single blastocyst for transfer. Participants are randomised (1:1:1) to either luteal phase progesterone for 3 weeks, luteal phase progesterone for 7 weeks or no luteal phase progesterone. The participating study centres consist of 12 in vitro fertilisation-clinics in Sweden and 1 in Iceland. The primary outcome is to investigate if luteal phase support (LPS) by vaginal progesterone increases the chance of a live birth per randomised patient in a natural FET cycle compared with no LPS.Ethics and disseminationThe trial was approved by the Swedish Ethical Review Authority (ID 2020-06774, 2021-02822 and 2022-01502-02) and the Swedish Medical Products Agency (ID nr 5.1-2020-102613). All participants are required to provide written informed consent. The outcome of this study will be disseminated to the public through broadcasts, newspapers and presentations at scientific congresses as well as publications in international scientific journals.Trial registration numberNCT04725864.

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“…Frozen-thawed embryo transfer in hormone replacement cycle has no own luteal generation and needs to completely rely on exogenous progesterone to maintain luteal function [19]. Whether luteal support is required for FET during natural cycles remains controversial [7,[20][21][22]. Previous studies suggested that the corpus luteum, produced by spontaneous ovulation, can maintain embryo implantation [23].…”

Section: Discussionmentioning

confidence: 99%

Does the addition of luteal function support drug benefit pregnancy and perinatal outcome in modified natural cycle frozen thawed embryo transfer in women under the age of 35- year-old?

Zhang

Ren

et al. 2022

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Background:In the freeze-thaw embryo transfer, the use of best luteal phase support protocols is continuously being discussed, especially in the natural cycles. Previous comparisons of luteal phase support protocols in natural cycles focused on pregnancy outcome, with less attention to perinatal outcome. Thus, convincing conclusion about which protocol is more appropriate could not be drawn. At the same time, with increasing luteal support drugs, the benefit of using these drugs also needs evidence. Methods: The clinical data of 3658 mNC-FET cycles in the Reproductive Center of the Third Affiliated Hospital of Zhengzhou University from January 2018 to December 2020 with the participants’ age of less than or equal to 35 years old，were retrospectively analyzed. The cycles were divided into three groups based on luteal phase support protocols used. The patients received a combination of progesterone soft capsule and dydrogesterone in the group A (882 cycles), the patients received dydrogesterone in the group B (627cycles), and the patients received a combination of progesterone vaginal sustained-release gel and dydrogesterone in the group C (2149 cycles). Pregnancy and perinatal outcomes in the group A, group B, and group C were compared. Results: HCG positive rate, clinical pregnancy rate, and implantation rate were higher in the group B than in the groups A and C （67.30% vs. 57.37% and 61.05%; 64.43% vs. 55.67 % and 57.88 %; 54.83 % vs 42.70 % and 45.92 %）. The 12-week pregnancy rate and live birth rate in the group B were higher than those in the group A （56.30% vs. 49.55%；53.26% vs. 46.83%）. There were no significant differences in newborn weight, premature delivery rate, pregnancy complications rate, and incidence of birth defects among the three groups. Logistic regression analyses showed that three different luteal phase support regimens were not associated with live birth rate （0R 95% CI B VS. A=1.23，P=0.056；0R 95%CI B VS. A=1.07，P=0.374）. Conclusions: In the mNC-FET cycle, patients younger than or equal to 35 years of age, who chose dydrogesterone alone as luteal support drug, had no difference in live birth rate and perinatal outcome between progesterone soft capsules or progesterone vaginal sustained-release gel combined with dydrogesterone, but the outcome still needs to be confirmed by large sample prospective studies.

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A randomized controlled trial of vaginal progesterone for luteal phase support in modified natural cycle – frozen embryo transfer

Cited by 16 publications

References 31 publications

Preparation of the Endometrium for Frozen Embryo Transfer: A Systematic Review

Preparation of the Endometrium for Frozen Embryo Transfer: A Systematic Review

Vaginal progesterone as luteal phase support in natural cycle frozen-thawed embryo transfer (ProFET): protocol for a multicentre, open-label, randomised controlled trial

Does the addition of luteal function support drug benefit pregnancy and perinatal outcome in modified natural cycle frozen thawed embryo transfer in women under the age of 35- year-old?

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