Immediate Versus Delayed FET Following a Stimulated IVF Cycle

NCT03201783 | Completed

• 1 other identifier: ShangHaiIVG
• Study Type: interventional
• Target: 724
• Locations: 1 country
• Sites: 1

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.

Conditions

Fertilization in Vitro; Embryo Transfer

Keywords

frozen-thawed embryo transfer; time interval

Outcome Measures

Primary Outcomes (1)

• ongoing pregnancy

  viable pregnancy beyond gestation 12 weeks

  viable pregnancy beyond gestation 12 weeks

Secondary Outcomes (9)

• Positive hCG level

  A blood pregnancy test is performed 14 days after the FET

• clinical pregnancy

  presence of intrauterine gestational sac on ultrasound at 6 weeks of pregnancy

• biochemical pregnancy:

  positive blood pregnancy test not followed by clinical pregnancy during 12 weeks gestation

• implantation rate

  number of gestational sacs per embryo transferred during 4 weeks of pregnancy

• multiple pregnancy

  multiple pregnancy beyond gestation 12 weeks

Study Arms (2)

immediate group

OTHER

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

delayed group

OTHER

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

Interventions

immediate frozen-thawed embryo transfer OTHER

Frozen-thawed embryo transfer will be performed in the first cycle following the stimulated IVF cycle

immediate group

delayed frozen-thawed embryo transfer OTHER

Frozen-thawed embryo transfer will be performed at least in the second cycle following the stimulated IVF cycle

delayed group

Eligibility Criteria

• Age: 20 Years - 43 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• ShangHai Ji Ai Genetics & IVF Institute: lead
• The University of Hong Kong: collaborator

Study Sites (1)

ShangHai JIAI Genetics&IVF Institute

Shanghai, China

Location

Related Publications (6)

• 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

• 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

• 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

• 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.

  PMID: 33885131 DERIVED

• 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.

  PMID: 29773699 DERIVED

Study Officials

• XIAOXI SUN, PHD

  Shanghai JiAi Genetics & IVF Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: No masking because of the nature of the intervention
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 23, 2017
• First Posted: June 28, 2017
• Study Start: August 9, 2017
• Primary Completion: March 4, 2019
• Study Completion: December 31, 2019
• Last Updated: May 14, 2020

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will share

Locations

CN (1)