Estrogen Supplementation Mode in HRT-FET Cycle: a RCT

August 6, 2020 updated by: Haiyan Lin, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

784

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 42 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
live-birth rate per ET
Time Frame: Up to 12 months
Live birth was defined as the delivery of at least one live born baby beyond 28 weeks of gestation.
Up to 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
clinical pregnancy rate
Time Frame: Up to 6 months
- clinical pregnancy: presence of intrauterine gestational sac on pelvic ultrasound at 6 weeks of gestation
Up to 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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 record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

November 1, 2020

Primary Completion (Anticipated)

November 1, 2022

Study Completion (Anticipated)

December 1, 2023

Study Registration Dates

First Submitted

July 27, 2020

First Submitted That Met QC Criteria

August 6, 2020

First Posted (Actual)

August 7, 2020

Study Record Updates

Last Update Posted (Actual)

August 7, 2020

Last Update Submitted That Met QC Criteria

August 6, 2020

Last Verified

July 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HRT-E2

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

Until the completion of the study.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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