Firouzeh Ghaffari1, Zahra Chekini2, Samira Vesali3. 1. Department of Endocrinology and Female Infertility, Reproductive Biomedicine Research Center, Royan Institute for Reproductive Biomedicine, ACECR, Royan Allay, Eastern Hafez St, Banihashem Sq., Resalat Highway, 1665659711, Tehran, Iran. ghafaryf@yahoo.com. 2. Department of Endocrinology and Female Infertility, Reproductive Biomedicine Research Center, Royan Institute for Reproductive Biomedicine, ACECR, Royan Allay, Eastern Hafez St, Banihashem Sq., Resalat Highway, 1665659711, Tehran, Iran. 3. Reproductive Epidemiology Research Center, Royan Institute for Reproductive Biomedicine, ACECR, Tehran, Iran.
Abstract
PURPOSE: In this study, we intend to evaluate pregnancy outcomes in women who undergo artificial frozen embryo transfer (FET) and stop estradiol (E2) after vaginal ultrasound observation of a gestational sac and heartbeat. METHODS: In this randomized phase III clinical trial, we recruited 291 patients who underwent FET. We randomly assigned 64 pregnant women to a study or a control group after observation of a gestational sac and heartbeat at 6-week gestational age. E2 administration continued until week 12 of gestational age for the control group, but was discontinued for the study group. Progesterone-in-oil administration continued until week 12 of gestational age for both groups. Serum levels for E2 and progesterone were measured on the initial progesterone and embryo transfer (ET) days, and at weeks 6 and 12 of pregnancy in both groups. RESULTS: The miscarriage rate was 1/32 (3.13%) in the study group and 6/32 (18.75%) in the control group after the intervention and confirmation of a fetal heartbeat. This difference was statistically significant. All patients who remained under intervention, which included 29 in the study group and 24 in the control group, had live births. Although the mean serum E2 and progesterone levels steadily increased from the initial day of progesterone administration to week 12 of gestational age, they were not significantly different between the two groups. Maternal complications were significantly more common in the control group. CONCLUSION: Earlier discontinuation of E2 for luteal phase support of FET cycles may be taken into consideration. Additional clinical studies should be conducted to determine an accurate estimation of the time when E2 should be discontinued during FET luteal phase support. TRIAL REGISTRATION: NCT04013438, registered 9 July 2019-Retrospectively registered, https://www. CLINICALTRIALS: gov/ct2/show/NCT04013438?cond=NCT04013438&draw=2&rank=1.
PURPOSE: In this study, we intend to evaluate pregnancy outcomes in women who undergo artificial frozen embryo transfer (FET) and stop estradiol (E2) after vaginal ultrasound observation of a gestational sac and heartbeat. METHODS: In this randomized phase III clinical trial, we recruited 291 patients who underwent FET. We randomly assigned 64 pregnant women to a study or a control group after observation of a gestational sac and heartbeat at 6-week gestational age. E2 administration continued until week 12 of gestational age for the control group, but was discontinued for the study group. Progesterone-in-oil administration continued until week 12 of gestational age for both groups. Serum levels for E2 and progesterone were measured on the initial progesterone and embryo transfer (ET) days, and at weeks 6 and 12 of pregnancy in both groups. RESULTS: The miscarriage rate was 1/32 (3.13%) in the study group and 6/32 (18.75%) in the control group after the intervention and confirmation of a fetal heartbeat. This difference was statistically significant. All patients who remained under intervention, which included 29 in the study group and 24 in the control group, had live births. Although the mean serum E2 and progesterone levels steadily increased from the initial day of progesterone administration to week 12 of gestational age, they were not significantly different between the two groups. Maternal complications were significantly more common in the control group. CONCLUSION: Earlier discontinuation of E2 for luteal phase support of FET cycles may be taken into consideration. Additional clinical studies should be conducted to determine an accurate estimation of the time when E2 should be discontinued during FET luteal phase support. TRIAL REGISTRATION: NCT04013438, registered 9 July 2019-Retrospectively registered, https://www. CLINICALTRIALS: gov/ct2/show/NCT04013438?cond=NCT04013438&draw=2&rank=1.
Authors: Eva R Groenewoud; Astrid E P Cantineau; Boudewijn J Kollen; Nick S Macklon; Ben J Cohlen Journal: Hum Reprod Update Date: 2017-03-01 Impact factor: 15.610
Authors: D de Ziegler; C Bergeron; C Cornel; D A Medalie; M R Massai; E Milgrom; R Frydman; P Bouchard Journal: J Clin Endocrinol Metab Date: 1992-02 Impact factor: 5.958