Immediate Versus Postponed Freeze-all Embryo Transfer in Hyperresponders

May 28, 2023 updated by: Li Rong, Peking University Third Hospital

Immediate Versus Postponed Freeze-all Embryo Transfer in Hyperresponders, A Multicenter Randomised Controlled Trial

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.

Study Overview

Status

Recruiting

Conditions

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

836

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 Locations

      • Beijing, China, 100191
        • Recruiting
        • Peking University Third Hospital
        • Contact:

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

Yes

Description

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.

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

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.

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

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Live birth after the first embryo transfer
Time Frame: At least 22 months gestation after the first embryo transfer cycle
Live birth is defined as the delivery of at least one baby after 22 weeks of gestation that exhibits any sign of life.
At least 22 months gestation after the first embryo transfer cycle

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical pregnancy
Time Frame: around 7 weeks' gestation after the first embryo transfer cycle
defined as at least one gestational sac on ultrasound at around 7 weeks' gestation with the detection of heart-beat activity
around 7 weeks' gestation after the first embryo transfer cycle
Ongoing pregnancy
Time Frame: 12 weeks' gestation or beyond after the first embryo transfer cycle
defined as pregnancy with detectable heart rate at 12 weeks' gestation or beyond
12 weeks' gestation or beyond after the first embryo transfer cycle
Biochemical pregnancy
Time Frame: about 12 days after embryo transfer
defined as a positive pregnancy test
about 12 days after embryo transfer
Ectopic pregnancy
Time Frame: about 6 weeks after embryo transfer
defined as embryo implanted at any site other than the endometrial lining of the uterus cavity
about 6 weeks after embryo transfer
Pre-eclampsia
Time Frame: after 20 weeks of gestation
defined as the development of gestational hypertension with proteinuria (≥300 mg/24-hour urine collection or 30 mg/dL in single urine sample) of new onset after 20 weeks of gestation
after 20 weeks of gestation
Premature rupture of membrane (PROM) rate
Time Frame: the day of delivery
defined as rupture of the amniotic membranes before the onset of labor including PROM at term and preterm PROM
the day of delivery
Preterm delivery
Time Frame: less than 37 and more than 21 weeks' gestational age
defined as delivery of a fetus at less than 37 weeks' gestational age
less than 37 and more than 21 weeks' gestational age
Placenta previa
Time Frame: the day of delivery
defined as a placenta that is implanted over or very close to the internal cervical orifice
the day of delivery
Postpartum hemorrhage
Time Frame: the day of delivery
defined as the loss of 500 ml of blood or more after completion of the third stage of labor
the day of delivery
Birth weight
Time Frame: the day of delivery
Birth weight
the day of delivery
Stillbirth
Time Frame: the day of delivery
defined as the absence of signs of life at or after birth
the day of delivery
Miscarriage
Time Frame: 6-22 weeks of gestation
defined as spontaneous loss of a clinical pregnancy before 22 completed weeks of gestational age, in which the embryo(s) or fetus(es) is/are nonviable or is/are absorbed or expelled from the uterus.
6-22 weeks of gestation
Cumulative live birth
Time Frame: 6 month after the first embryo transfer
the cumulative rate of live born children conceived within six months of the first FET cycle.
6 month after the first embryo transfer
Gestational hypertension
Time Frame: after 20 weeks of gestation
defined as the development of blood pressure greater than 140/90 mmHg after pregnancy without proteinuria or other signs of preeclampsia
after 20 weeks of gestation
Gestational diabetes mellitus
Time Frame: after 24 weeks of gestation
defined as carbohydrate intolerance of variable severity with onset or first recognition during pregnancy as determined from the diagnosis in the obstetrical medical record
after 24 weeks of gestation
Mode of delivery
Time Frame: the day of delivery
Vaginal birth or Caesarean Section
the day of delivery

Collaborators and Investigators

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

Investigators

  • Principal Investigator: Kai-Lun Hu, M.D, Peking University Third Hospital

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 (Actual)

August 30, 2022

Primary Completion (Estimated)

December 1, 2023

Study Completion (Estimated)

December 1, 2024

Study Registration Dates

First Submitted

July 20, 2022

First Submitted That Met QC Criteria

July 31, 2022

First Posted (Actual)

August 2, 2022

Study Record Updates

Last Update Posted (Actual)

May 31, 2023

Last Update Submitted That Met QC Criteria

May 28, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • Delay-ET-RCT

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Results of the study will be submitted to scientific conferences in reproductive medicine and a peer-reviewed journal.

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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