Estrogen Supplementation Mode in HRT-FET Cycle: a RCT

NCT04503915 | Unknown DMC

• 1 other identifier: HRT-E2
• Study Type: interventional
• Target: 784
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Hormone Replacement Therapy; Estrogen; Live Birth Rate

Keywords

estrogen supplementation; HRT; Live birth rate

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• clinical pregnancy rate

  Up to 6 months

Study Arms (2)

Constant group

EXPERIMENTAL

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

Step -up group

ACTIVE COMPARATOR

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

Interventions

different estrogen supplementation modes PROCEDURE

The different estrogen supplementation modes are randomized into two groups.

Constant group; Step -up group

Eligibility Criteria

• Age: 20 Years - 42 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Women aged \<42 years at the time of HRT-FET
• Replacing 1-2 early cleavage embryos or blastocysts after thawing.

You may not qualify if:

• 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

Sponsors & Collaborators

• Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University: lead

Study Officials

• Yi Zhang

  Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

  STUDY CHAIR

Central Study Contacts

Haiyan Lin

CONTACT

15913154456; 709235159@qq.com

Qingxue Zhang

CONTACT

81332233; zhangqingxue666@aliyun.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending physician

Study Record Dates

• First Submitted: July 27, 2020
• First Posted: August 7, 2020
• Study Start: November 1, 2020
• Primary Completion: November 1, 2022
• Study Completion: December 1, 2023
• Last Updated: August 7, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share