Estrogen Supplementation Mode in HRT-FET Cycle: a RCT

Hormone Replacement Therapy Clinical Trial

Official title:

A Multicenter Randomized Controlled Trial Comparing a Step-wise Increase Versus a Constant Dose of Estrogen Supplementation in Frozen-thawed Embryo Transfer Cycles Using Hormone Replacement

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04503915
• Other study ID #: HRT-E2
• Status: Not yet recruiting
• Phase: N/A
• Start date: November 1, 2020
• Est. completion date: December 1, 2023

Study information

• Verified date: July 2020
• Source: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
• Contact: Haiyan Lin
• Phone: 15913154456
• Email: 709235159[@]qq.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 784
• Est. completion date: December 1, 2023
• Est. primary completion date: November 1, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 42 Years

Eligibility

Inclusion Criteria:

• Women aged <42 years at the time of HRT-FET

• Replacing 1-2 early cleavage embryos or blastocysts after thawing.

Exclusion Criteria:

• Preimplantation genetic testing(PGT)

• Use of donor oocytes

• Hydrosalpinx shown on pelvic scanning and not surgically treated such as tubal ligation or resection

• Severe uterine adhesion

• The endometrial thickness cannot reach 8mm in previous fresh cycles or HRT -FET cycles

Related Conditions & MeSH terms

• Estrogen
• Hormone Replacement Therapy
• Live Birth Rate

Intervention

Procedure:
• different estrogen supplementation modes
The different estrogen supplementation modes are randomized into two groups.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	live-birth rate per ET	Live birth was defined as the delivery of at least one live born baby beyond 28 weeks of gestation.	Up to 12 months
Secondary	clinical pregnancy rate	- clinical pregnancy: presence of intrauterine gestational sac on pelvic ultrasound at 6 weeks of gestation	Up to 6 months