Immediate Versus Delayed FET Following a Stimulated IVF Cycle

Not Applicable

Completed

• Conditions: Embryo Transfer; Fertilization in Vitro
• Interventions: Other: delayed frozen-thawed embryo transfer; Other: immediate frozen-thawed embryo transfer

• Registration Number: NCT03201783
• Lead Sponsor: ShangHai Ji Ai Genetics & IVF Institute

Brief Summary

Information regarding the optimal timing for frozen-thawed embryo transfer (FET) following a stimulated in vitro fertilization (IVF) is lacking. One option is to perform FET in the first cycle following the stimulated IVF cycle, i.e. immediate transfer. Another option is to postpone FET for at least one menstrual cycle, i.e. delayed transfer. This randomized study aims to compare the ongoing pregnancy rate of immediate versus delayed FET following a stimulated IVF cycle.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-06-23
• Study First Submitted QC: 2017-06-26
• Study First Posted: 2017-06-28
• Study Start: 2017-08-09
• Primary Completion: 2019-03-04
• Status Verified: 2019-09
• Study Completion: 2019-12-31
• Last Update Submitted: 2020-05-13
• Last Update Posted: 2020-05-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 724

Inclusion Criteria

• Women aged ≤43 years at the time of IVF/ICSI treatment Undergoing IVF with a standard stimulation At least one frozen embryo or blastocyst The first FET cycle following ovarian stimulation in IVF/ICSI

Exclusion Criteria

• Use of mild stimulation or natural cycle for IVF/ICSI treatment Severe ovarian hyperstimulation syndrome during IVF/ICSI treatment Preimplantation genetic diagnosis treatment Use of donor oocytes Presence of hydrosalpinx which is not surgically treated or endometrial polyp on scanning during ovarian stimulation

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
delayed group	delayed frozen-thawed embryo transfer	the intervention: delayed frozen-thawed embryo transfer (FET) which means FET will be performed at least in the second cycle following the stimulated IVF cycle
immediate group	immediate frozen-thawed embryo transfer	the intervention: immediate frozen-thawed embryo transfer (FET) which means FET will be performed in the first cycle following the stimulated IVF cycle

Primary Outcome Measures

Name	Time	Method
ongoing pregnancy	viable pregnancy beyond gestation 12 weeks	viable pregnancy beyond gestation 12 weeks

Secondary Outcome Measures

Name	Time	Method
Positive hCG level	A blood pregnancy test is performed 14 days after the FET	the result of serum β-hCG ≥10 mIU/mL.
clinical pregnancy	presence of intrauterine gestational sac on ultrasound at 6 weeks of pregnancy	presence of intrauterine gestational sac on ultrasound
biochemical pregnancy:	positive blood pregnancy test not followed by clinical pregnancy during 12 weeks gestation	positive blood pregnancy test not followed by clinical pregnancy
implantation rate	number of gestational sacs per embryo transferred during 4 weeks of pregnancy	number of gestational sacs per embryo transferred
multiple pregnancy	multiple pregnancy beyond gestation 12 weeks	more than one intrauterine sacs on scanning
ectopic pregnancy	ectopic pregnancy during 12 weeks gestation	pregnancy outside the uterine cavity
miscarriage	the loss of a pregnancy before 22 weeks gestation	the loss of a pregnancy before 22 weeks gestation
live birth rate	a live birth after 22 weeks gestation	the rate of live births per cycle
birth weight	a live birth after 22 weeks gestation	birth weight of the baby delivered

Trial Locations

Locations (1)

ShangHai JIAI Genetics&IVF Institute; 🇨🇳 Shanghai, China