Immediate Versus Delayed FET Following a Stimulated IVF Cycle

Embryo Transfer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03201783
• Other study ID #: ShangHaiIVG
• Status: Completed
• Phase: N/A
• Start date: August 9, 2017
• Est. completion date: December 31, 2019

Study information

• Verified date: September 2019
• Source: ShangHai Ji Ai Genetics & IVF Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 724
• Est. completion date: December 31, 2019
• Est. primary completion date: March 4, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 43 Years

Eligibility

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

Related Conditions & MeSH terms

• Embryo Transfer
• Fertilization in Vitro

Intervention

Other:
• immediate frozen-thawed embryo transfer
Frozen-thawed embryo transfer will be performed in the first cycle following the stimulated IVF cycle
• delayed frozen-thawed embryo transfer
Frozen-thawed embryo transfer will be performed at least in the second cycle following the stimulated IVF cycle

Locations

Country	Name	City	State
China	ShangHai JIAI Genetics&IVF Institute	Shanghai

Sponsors (2)

Lead Sponsor	Collaborator
ShangHai Ji Ai Genetics & IVF Institute	The University of Hong Kong

Country where clinical trial is conducted

China, 

References & Publications (4)

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. — View Citation

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. Epub 2016 Sep 8. — View Citation

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. — View Citation

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. — View Citation

Outcome

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