A Randomized Trial Comparing the Live Birth Rate of Immediate Versus Delayed FET Following a Freeze-all Strategy

NCT04371783 | Active Not Recruiting

• 1 other identifier: JIAI 2020-04
• Study Type: interventional
• Target: 828
• Locations: 1 country
• Sites: 1

Brief Summary

This randomized trial we aim to compare the live birth rate of immediate versus delayed FET replacing a single blastocyst in the first FET of the first stimulated IVF cycle following. The hypothesis is that the live birth rate of the immediate FET is higher than the delayed FET replacing a single blastocyst in the first FET of the first stimulated IVF cycle following a freeze-all strategy. Women will undergo IVF/ICSI in the centre as clinically indicated. Standard ovarian stimulation with gonadotrophins in a Gonadotrophin releasing hormone (GnRH) antagonist protocol will be employed. Hormone replacement treatment (HRT) will be used in subsequent FET cycles. On Day 3 of the menstrual cycle, we will measure the anxiety levels using the Chinese State-Trait Anxiety Inventory and serum E2, cortisol levels will be checked on the same day. Recruited women having the first FET cycle following a freeze all strategy will be randomly assigned on the day of blastocyst(s) freezing according to a computer-generated randomization list into one of the following two groups.

Conditions

IVF; Frozen Embryo Transfer

Outcome Measures

Primary Outcomes (1)

• live birth

  deliveries ≥22 weeks gestation with heartbeat and breath

  1 year after FET

Secondary Outcomes (8)

• positive hCG

  2 weeks after FET

• clinical pregnancy

  6 weeks' gestation

• ongoing pregnancy

  12 weeks' gestation

• implantation rate

  6 weeks' gestation

• miscarriage

  1 year after FET

Study Arms (2)

Immediate FET group

OTHER

FET will be performed in the first menstrual cycle following the stimulated IVF cycle

Procedure: Immediate FET

Delayed FET group

OTHER

FET will be performed in the second menstrual cycle following the stimulated IVF cycle

Procedure: Delayed FET

Interventions

Delayed FET PROCEDURE

FET is performed in the second menstrual cycle following the stimulated IVF cycle

Delayed FET group

Immediate FET PROCEDURE

FET is performed in the first menstrual cycle following the stimulated IVF cycle

Immediate FET group

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Women aged 20-40 years at the time of IVF/ICSI
• Women undergoing their first FET of the first IVF cycle following a freeze-all strategy
• Undergoing IVF with GnRH antagonist
• At least one frozen blastocyst

You may not qualify if:

• Severe ovarian hyperstimulation syndrome during the first IVF/ICSI cycle
• Preimplantation genetic testing
• Use of donor oocytes
• Presence of untreated hydrosalpinx or endometrial polyp on scanning during ovarian stimulation

Sponsors & Collaborators

• ShangHai Ji Ai Genetics & IVF Institute: lead

Study Sites (1)

Shanghai JiAi Genetics & IVF Institute

Shanghai, Shanghai Municipality, 200011, China

Location

Related Publications (9)

• Doody KJ. Cryopreservation and delayed embryo transfer-assisted reproductive technology registry and reporting implications. Fertil Steril. 2014 Jul;102(1):27-31. doi: 10.1016/j.fertnstert.2014.04.048. Epub 2014 Jun 4.

  PMID: 24907917 BACKGROUND

• Shapiro BS, Daneshmand ST, Garner FC, Aguirre M, Hudson C, Thomas S. Evidence of impaired endometrial receptivity after ovarian stimulation for in vitro fertilization: a prospective randomized trial comparing fresh and frozen-thawed embryo transfer in normal responders. Fertil Steril. 2011 Aug;96(2):344-8. doi: 10.1016/j.fertnstert.2011.05.050. Epub 2011 Jul 6.

  PMID: 21737072 BACKGROUND

• Venetis CA, Kolibianakis EM, Bosdou JK, Lainas GT, Sfontouris IA, Tarlatzis BC, Lainas TG. Estimating the net effect of progesterone elevation on the day of hCG on live birth rates after IVF: a cohort analysis of 3296 IVF cycles. Hum Reprod. 2015 Mar;30(3):684-91. doi: 10.1093/humrep/deu362. Epub 2015 Jan 12.

  PMID: 25586787 BACKGROUND

• 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.

  PMID: 27609984 BACKGROUND

• 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.

  PMID: 26806686 BACKGROUND

• 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.

  PMID: 27986819 BACKGROUND

• 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.

  PMID: 28041829 BACKGROUND

• Higgins C, Healey M, Jatkar S, Vollenhoven B. Interval between IVF stimulation cycle and frozen embryo transfer: Is there a benefit to a delay between cycles? Aust N Z J Obstet Gynaecol. 2018 Apr;58(2):217-221. doi: 10.1111/ajo.12696. Epub 2017 Sep 14.

  PMID: 28905357 BACKGROUND

• Li H, Zhang W, Chen J, Lu X, Li L, Sun X, Ng EH. Immediate versus delayed single blastocyst transfer following the first stimulated IVF cycle in the freeze-all strategy: a study protocol for a randomised controlled trial. BMJ Open. 2024 May 8;14(5):e081018. doi: 10.1136/bmjopen-2023-081018.

  PMID: 38719320 DERIVED

Study Officials

• Xiaoxi Sun, Phd

  Shanghai JiAi Genetics & IVF Institute

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 29, 2020
• First Posted: May 1, 2020
• Study Start: May 4, 2020
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: February 2, 2026

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR, ANALYTIC CODE
• Time Frame: Data will be available when beginning 3 months and ending 5 years following article publication.
• Access Criteria: To achieve aims in the approved proposal, researchers who provide a methodologically sound proposal will be shared with. Proposals should be directed to lihe198900@163.com.

Locations

CN (1)