Clinical trial NCT05483270: Immediate Versus Postponed Freeze-all Embryo Transfer in Hyperresponders
Official title: Immediate Versus Postponed Freeze-all Embryo Transfer in Hyperresponders, a Multicenter Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: IVF
Lead sponsor: Peking University Third Hospital
Sponsor class: OTHER
Collaborators: name: Women's Hospital School Of Medicine Zhejiang University
name: The Affiliated Hospital Of Guizhou Medical University
name: Shengjing Hospital
First posted: 2022-08-02
Enrollment: 845
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 42
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Live birth after the first embryo transfer
timeFrame: At least 22 months gestation after the first embryo transfer cycle
Secondary outcomes:
measure: Clinical pregnancy
timeFrame: around 7 weeks' gestation after the first embryo transfer cycle
measure: Ongoing pregnancy
timeFrame: 12 weeks' gestation or beyond after the first embryo transfer cycle
measure: Biochemical pregnancy
timeFrame: about 12 days after embryo transfer
measure: Ectopic pregnancy
timeFrame: about 6 weeks after embryo transfer
measure: Miscarriage
timeFrame: 6-22 weeks of gestation
measure: Cumulative live birth
timeFrame: 6 month after the first embryo transfer
measure: Pre-eclampsia
timeFrame: after 20 weeks of gestation
measure: Gestational hypertension
timeFrame: after 20 weeks of gestation
measure: Gestational diabetes mellitus
timeFrame: after 24 weeks of gestation
measure: Premature rupture of membrane (PROM) rate
timeFrame: the day of delivery
measure: Preterm delivery
timeFrame: less than 37 and more than 21 weeks' gestational age
measure: Placenta previa
timeFrame: the day of delivery
measure: Postpartum hemorrhage
timeFrame: the day of delivery
measure: Birth weight
timeFrame: the day of delivery
measure: Stillbirth
timeFrame: the day of delivery
measure: Mode of delivery
timeFrame: the day of delivery
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking university third hospital
Study officials:
affiliation: Peking University Third Hospital
name: Kai-Lun Hu, M.D
role: PRINCIPAL_INVESTIGATOR
References: