Immediate Versus Postponed Freeze-all Embryo Transfer in Hyperresponders

IVF Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05483270
• Other study ID #: Delay-ET-RCT
• Status: Recruiting
• Phase: N/A
• Start date: August 30, 2022
• Est. completion date: December 2024

Study information

• Verified date: May 2023
• Source: Peking University Third Hospital
• Contact: Kai-Lun Hu, M.D
• Phone: 15901575271
• Email: hukailun[@]bjmu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 836
• Est. completion date: December 2024
• Est. primary completion date: December 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years to 42 Years

Eligibility

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.

Related Conditions & MeSH terms

• IVF

Intervention

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.

Locations

Country	Name	City	State
China	Peking university third hospital	Beijing

Sponsors (4)

Lead Sponsor	Collaborator
Peking University Third Hospital	Shengjing Hospital, The Affiliated Hospital Of Guizhou Medical University, Women's Hospital School Of Medicine Zhejiang University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Live birth after the first embryo transfer	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	Clinical pregnancy	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
Secondary	Ongoing pregnancy	defined as pregnancy with detectable heart rate at 12 weeks' gestation or beyond	12 weeks' gestation or beyond after the first embryo transfer cycle
Secondary	Biochemical pregnancy	defined as a positive pregnancy test	about 12 days after embryo transfer
Secondary	Ectopic pregnancy	defined as embryo implanted at any site other than the endometrial lining of the uterus cavity	about 6 weeks after embryo transfer
Secondary	Miscarriage	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
Secondary	Cumulative live birth	the cumulative rate of live born children conceived within six months of the first FET cycle.	6 month after the first embryo transfer
Secondary	Pre-eclampsia	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
Secondary	Gestational hypertension	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
Secondary	Gestational diabetes mellitus	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
Secondary	Premature rupture of membrane (PROM) rate	defined as rupture of the amniotic membranes before the onset of labor including PROM at term and preterm PROM	the day of delivery
Secondary	Preterm delivery	defined as delivery of a fetus at less than 37 weeks' gestational age	less than 37 and more than 21 weeks' gestational age
Secondary	Placenta previa	defined as a placenta that is implanted over or very close to the internal cervical orifice	the day of delivery
Secondary	Postpartum hemorrhage	defined as the loss of 500 ml of blood or more after completion of the third stage of labor	the day of delivery
Secondary	Birth weight	Birth weight	the day of delivery
Secondary	Stillbirth	defined as the absence of signs of life at or after birth	the day of delivery
Secondary	Mode of delivery	Vaginal birth or Caesarean Section	the day of delivery