NCT05483270

Immediate Versus Postponed Freeze-all Embryo Transfer in Hyperresponders

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 845 (actual)
• Sponsor: Peking University Third Hospital · Academic / Other
• Sex: Female
• Age: 20 Years – 42 Years
• Healthy volunteers: Accepted

Summary

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

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

• IVF

Interventions

Type	Name	Description
BIOLOGICAL	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.

Timeline

• Start date: 2022-08-30
• Primary completion: 2024-10-08
• Completion: 2024-11-24
• First posted: 2022-08-02
• Last updated: 2024-11-27

Locations

1 site across 1 country: China