Immediate Versus Delayed FET Following a Stimulated IVF Cycle

A Randomized Trial Comparing the Effect of Immediate Versus Delayed Frozen-thawed Embryo Transfer Following a Stimulated IVF Cycle

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.

Study Overview

• Status: Completed
• Conditions: Embryo Transfer; Fertilization in Vitro
• Intervention / Treatment: Other: immediate frozen-thawed embryo transfer; Other: delayed frozen-thawed embryo transfer

• Study Type: Interventional
• Enrollment (Actual): 724
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Shanghai, China
    • ShangHai JIAI Genetics&IVF Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 43 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: immediate group; the intervention: immediate frozen-thawed embryo transfer (FET) which means FET will be performed in the first cycle following the stimulated IVF cycle	Other: immediate frozen-thawed embryo transfer; Frozen-thawed embryo transfer will be performed in the first cycle following the stimulated IVF cycle
Other: delayed group; 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	Other: delayed frozen-thawed embryo transfer; Frozen-thawed embryo transfer will be performed at least in the second cycle following the stimulated IVF cycle

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ongoing pregnancy	viable pregnancy beyond gestation 12 weeks	viable pregnancy beyond gestation 12 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: ShangHai Ji Ai Genetics & IVF Institute
• Collaborators: The University of Hong Kong
• Investigators: Principal Investigator: XIAOXI SUN, PHD, Shanghai JiAi Genetics & IVF Institute

Publications and helpful links

General Publications

• Santos-Ribeiro S, Polyzos NP, Lan VT, Siffain J, Mackens S, Van Landuyt L, Tournaye H, Blockeel C. The effect of an immediate frozen embryo transfer following a freeze-all protocol: a retrospective analysis from two centres. Hum Reprod. 2016 Nov;31(11):2541-2548. doi: 10.1093/humrep/dew194. Epub 2016 Sep 8.
• Santos-Ribeiro S, Siffain J, Polyzos NP, van de Vijver A, van Landuyt L, Stoop D, Tournaye H, Blockeel C. To delay or not to delay a frozen embryo transfer after a failed fresh embryo transfer attempt? Fertil Steril. 2016 May;105(5):1202-1207.e1. doi: 10.1016/j.fertnstert.2015.12.140. Epub 2016 Jan 21.
• Lattes K, Checa MA, Vassena R, Brassesco M, Vernaeve V. There is no evidence that the time from egg retrieval to embryo transfer affects live birth rates in a freeze-all strategy. Hum Reprod. 2017 Feb;32(2):368-374. doi: 10.1093/humrep/dew306. Epub 2016 Dec 16.
• Volodarsky-Perel A, Eldar-Geva T, Holzer HE, Schonberger O, Reichman O, Gal M. Cryopreserved embryo transfer: adjacent or non-adjacent to failed fresh long GnRH-agonist protocol IVF cycle. Reprod Biomed Online. 2017 Mar;34(3):267-273. doi: 10.1016/j.rbmo.2016.11.013. Epub 2016 Dec 16.
• Li H, Sun X, Yang J, Li L, Zhang W, Lu X, Chen J, Chen H, Yu M, Fu W, Peng X, Chen J, Ng EHY. Immediate versus delayed frozen embryo transfer in patients following a stimulated IVF cycle: a randomised controlled trial. Hum Reprod. 2021 Jun 18;36(7):1832-1840. doi: 10.1093/humrep/deab071.
• Li H, Li L, Lu X, Sun X, Ng EHY. Comparison of the effect of immediate versus delayed transfer following a stimulated IVF cycle on the ongoing pregnancy rate of frozen-thawed embryo transfer cycles: a study protocol for a randomised controlled trial. BMJ Open. 2018 May 17;8(5):e020507. doi: 10.1136/bmjopen-2017-020507.

Study record dates

Study Major Dates

• Study Start (Actual): August 9, 2017
• Primary Completion (Actual): March 4, 2019
• Study Completion (Actual): December 31, 2019

Study Registration Dates

• First Submitted: June 23, 2017
• First Submitted That Met QC Criteria: June 26, 2017
• First Posted (Actual): June 28, 2017

Study Record Updates

• Last Update Posted (Actual): May 14, 2020
• Last Update Submitted That Met QC Criteria: May 13, 2020
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Keywords: frozen-thawed embryo transfer; time interval
• Other Study ID Numbers: ShangHaiIVG

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Individual participant data that underlie the results after deidentification (text, tables, figures, and appendices) and study protocol will be shared. Data will be available when beginning 3 months and ending 5 years following article publication. To achieve aims in the approved proposal, researchers who provide a methodologically sound proposal will be shared with.Data will be made available by the following way. Proposals should be directed to lihe198900@163.com. And data are available for 5 years at a third party website (link to be included after the article publication).

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No