An interventional study of different estrogen supplementation modes in Hormone Replacement Therapy, Estrogen and Live Birth Rate, sponsored by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University. Status unknown. Open to female participants aged 20 Years to 42 Years. Per ClinicalTrials.gov, last updated 2020-08-07.
Sponsored by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University · Not applicable, Interventional, and Treatment
A systematic review and meta-analysis concluded that there is insufficient evidence to recommend one particular protocol for HRT with regard to pregnancy rates after frozen embryo transfer, and no comparison of estrogen dose or route of administration was included in the review[7]. It is worth highlighting that the authors did not find any literature discussing the effect of estrogen dose and route of administration for HRT on reproductive outcomes. In 2016, a retrospective cohort study concluded that there is no difference in live birth rates between a constant dose versus an increasing dose of estrogen in oocyte donation cycles with oral or transdermal supplementation[6]. In order to provide good evidence about pattern of estrogen supplementation in HRT-FET, a randomized controlled study is urgently needed.
The present randomized controlled study aims to compare between a constant estrogen dose protocol and a step-wise increasing estrogen dose protocol on the live birth rate of HRT-FET cycles.
The objective is to compare between a constant estrogen dose protocol and a step-wise increasing estrogen dose protocol on live birth rate of HRT-FET cycles.
This is a multicenter randomized controlled trial. Women undergoing HRT-FET will be recruited and randomized to use a constant estrogen dose protocol and a step-wise increasing estrogen dose protocol.
Participation in the study is totally voluntary. The subjects can withdraw from the study at any time and they will still receive standard medical care.
Women being scheduled for HRT-FET will be assessed for eligibility. Eligible women will be recruited in the study and each woman will only be included in the study once.
Informed written consent will be obtained prior to recruitment. The baseline characteristics will be collected. Transvaginal ultrasound will be done to measure the endometrial thickness on the day of progesterone supplementation. Embryo transfer will be performed 3 days or 5 days after progesterone use, depending on replacement of cleaving stage embryos or blastocysts respectively.
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University is the lead sponsor of 466 studies on the registry; 271 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Women will receive oral estradiol valerate (Progynova®; Bayer Schering Pharma AG, Berlin, Germany) 3 mg bid for 14 days for endometrial priming from the second or third day of the menstrual cycle.
Procedure: different estrogen supplementation modes
Women will receive estradiol valerate 2mg once daily for 4 days from the second to fifth day,followed by 2mg bid for 4 days from the sixth to ninth day and then 3mg bid for 6 days from tenth to fifteenth day of menstrual cycle.
Procedure: different estrogen supplementation modes
The different estrogen supplementation modes are randomized into two groups.
live-birth rate per ET
Live birth was defined as the delivery of at least one live born baby beyond 28 weeks of gestation.
Time frame: Up to 12 months
clinical pregnancy rate
- clinical pregnancy: presence of intrauterine gestational sac on pelvic ultrasound at 6 weeks of gestation
Time frame: Up to 6 months
No study locations are listed for this record.
Plan to share: No — Until the completion of the study.
No publications or documents are linked to this record.
This study is status unknown, as verified in Jul 2020. You cannot join it, but the record below documents what was studied.
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Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University