Estrogen Supplementation Mode in HRT-FET Cycle: a RCT

NCT ID: NCT04503915

Last Updated: 2020-08-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

784 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-11-01

Study Completion Date

2023-12-01

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Hormone Replacement Therapy Estrogen Live Birth Rate

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

different estrogen supplementation modes

Intervention Type PROCEDURE

The different estrogen supplementation modes are randomized into two groups.

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.

Group Type ACTIVE_COMPARATOR

different estrogen supplementation modes

Intervention Type PROCEDURE

The different estrogen supplementation modes are randomized into two groups.

Interventions

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different estrogen supplementation modes

The different estrogen supplementation modes are randomized into two groups.

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

42 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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

OTHER

Sponsor Role lead

Responsible Party

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Haiyan Lin

Attending physician

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Yi Zhang

Role: STUDY_CHAIR

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

Central Contacts

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Haiyan Lin

Role: CONTACT

15913154456

Qingxue Zhang

Role: CONTACT

81332233 ext. 13602797433

Other Identifiers

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HRT-E2

Identifier Type: -

Identifier Source: org_study_id

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