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Immediate Versus Postponed Freeze-all Embryo Transfer in Hyperresponders

NCT ID: NCT05483270

Last Updated: 2024-11-27

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

COMPLETED

Clinical Phase

NA

Total Enrollment

845 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-08-30

Study Completion Date

2024-11-24

Brief Summary

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This is a multicenter, randomised controlled trial. The investigators plan to randomise 836 participants to the immediate FET or the postponed FET from the day of oocyte retrieval to the last day of that menstrual cycle in a 1:1 rate. Primary outcome will be the live birth rate after the embryo transfer.

Detailed Description

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It is postulated that postponing embryo transfer for at least one menstrual cycle after a freeze-all cycle can minimise the possible residual negative effect caused by ovarian stimulation and can promote the resumption of a normal ovulatory cycle and the receptivity of endometrium. Nevertheless, emerging evidence suggests a higher live birth rate in the immediate freeze-all embryo transfer (FET) cycles compared to that in the delayed group. It is unclear the whether postponed FET is superior in hyperresponders. The investigators hypothesize the success rate in the postponed FET for at least one menstrual cycle after oocyte retrieval is higher than in the immediate FET in hyperresponders.

Objective: To evaluate whether the postponed FET for at least one menstrual cycle after oocyte retrieval is superior to the immediate FET in the first menstrual cycle after oocyte retrieval in hyperresponders in terms of live birth rates.

Design: a multicenter, randomised controlled trial Patients: The investigators plan to randomise participants to the immediate FET and the postponed FET from the day of oocyte retrieval to the last day of that menstrual cycle.

Primary outcome: live birth rate after the embryo transfer. Patients who get pregnant will be followed up until 6 weeks after delivery.

Sample size: The investigators plan to enroll 836 participants in a 1:1 rate.

Conditions

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IVF

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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Immediate FET group

Freeze-all embryo transfer will be carried out in the menstrual cycle immediately following oocyte retrieval.

Group Type ACTIVE_COMPARATOR

the timing of embryo transfer in freeze-all cycles

Intervention Type BIOLOGICAL

Immediate FET group Freeze-all embryo transfer will be carried out in the menstrual cycle immediately following oocyte retrieval.

Postponed FET group Freeze-all embryo transfer will be carried out during the second menstrual cycle to 6 months after oocyte retrieval.

Postponed FET group

Freeze-all embryo transfer will be carried out during the second menstrual cycle to 6 months after oocyte retrieval.

Group Type EXPERIMENTAL

the timing of embryo transfer in freeze-all cycles

Intervention Type BIOLOGICAL

Immediate FET group Freeze-all embryo transfer will be carried out in the menstrual cycle immediately following oocyte retrieval.

Postponed FET group Freeze-all embryo transfer will be carried out during the second menstrual cycle to 6 months after oocyte retrieval.

Interventions

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the timing of embryo transfer in freeze-all cycles

Immediate FET group Freeze-all embryo transfer will be carried out in the menstrual cycle immediately following oocyte retrieval.

Postponed FET group Freeze-all embryo transfer will be carried out during the second menstrual cycle to 6 months after oocyte retrieval.

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* Women aged 20 to 42 years old;
* Written informed consent;
* Women scheduled for freeze-all embryo transfer;
* Women with the number of oocyte collected higher than 15.

Exclusion Criteria

* Women with a history of at lease three failed transfer cycles;
* Women with an endometrial thickness less than 7 mm on the triggering day;
* Severe uterine malformations.
Minimum Eligible Age

20 Years

Maximum Eligible Age

42 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Women's Hospital School Of Medicine Zhejiang University

OTHER

Sponsor Role collaborator

The Affiliated Hospital Of Guizhou Medical University

OTHER

Sponsor Role collaborator

Shengjing Hospital

OTHER

Sponsor Role collaborator

Peking University Third Hospital

OTHER

Sponsor Role lead

Responsible Party

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Li Rong

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Kai-Lun Hu, M.D

Role: PRINCIPAL_INVESTIGATOR

Peking University Third Hospital

Locations

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Peking university third hospital

Beijing, , China

Site Status

Countries

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China

Other Identifiers

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Delay-ET-RCT

Identifier Type: -

Identifier Source: org_study_id