Estrogen Supplementation Mode in HRT-FET Cycle: a RCT

Sponsor
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT04503915
Collaborator
(none)
784
2
37

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: different estrogen supplementation modes
N/A

Detailed 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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
784 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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
Anticipated Study Start Date :
Nov 1, 2020
Anticipated Primary Completion Date :
Nov 1, 2022
Anticipated Study Completion Date :
Dec 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Constant group

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
The different estrogen supplementation modes are randomized into two groups.

Active Comparator: Step -up group

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.

Outcome Measures

Primary Outcome Measures

  1. live-birth rate per ET [Up to 12 months]

    Live birth was defined as the delivery of at least one live born baby beyond 28 weeks of gestation.

Secondary Outcome Measures

  1. clinical pregnancy rate [Up to 6 months]

    - clinical pregnancy: presence of intrauterine gestational sac on pelvic ultrasound at 6 weeks of gestation

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years to 42 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

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

Investigators

  • Study Chair: Yi Zhang, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Haiyan Lin, Attending physician, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
ClinicalTrials.gov Identifier:
NCT04503915
Other Study ID Numbers:
  • HRT-E2
First Posted:
Aug 7, 2020
Last Update Posted:
Aug 7, 2020
Last Verified:
Jul 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Haiyan Lin, Attending physician, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 7, 2020