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

IVF Clinical Trial

— FET  

Official title:

A Randomized Trial Comparing the Live Birth Rate of Immediate Versus Delayed Frozen Embryo Transfer (FET) Replacing a Single Blastocyst in the First FET of the First Stimulated IVF Cycle Following a Freeze-all Strategy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04371783
• Other study ID #: JIAI 2020-04
• Status: Recruiting
• Phase: N/A
• Start date: May 4, 2020
• Est. completion date: June 30, 2026

Study information

• Verified date: February 2024
• Source: ShangHai Ji Ai Genetics & IVF Institute
• Contact: HE LI, MD
• Phone: +8602163459977
• Email: lihe198900[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 828
• Est. completion date: June 30, 2026
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 40 Years

Eligibility

Inclusion Criteria:

1. Women aged 20-40 years at the time of IVF/ICSI

2. Women undergoing their first FET of the first IVF cycle following a freeze-all strategy

3. Undergoing IVF with GnRH antagonist

4. At least one frozen blastocyst

Exclusion Criteria:

1. Severe ovarian hyperstimulation syndrome during the first IVF/ICSI cycle

2. Preimplantation genetic testing

3. Use of donor oocytes

4. Presence of untreated hydrosalpinx or endometrial polyp on scanning during ovarian stimulation

Related Conditions & MeSH terms

• Frozen Embryo Transfer
• IVF

Intervention

Procedure:
• Immediate FET
FET is performed in the first menstrual cycle following the stimulated IVF cycle
• Delayed FET
FET is performed in the second menstrual cycle following the stimulated IVF cycle

Locations

Country	Name	City	State
China	Shanghai JiAi Genetics & IVF Institute	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
ShangHai Ji Ai Genetics & IVF Institute

Country where clinical trial is conducted

China, 

References & Publications (8)

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. — View Citation

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. — View Citation

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. doi: 10.1093/humrep/dew194. 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

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. — View Citation

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. — 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	live birth	deliveries =22 weeks gestation with heartbeat and breath	1 year after FET
Secondary	positive hCG	serum ß-hCG =10 mIU/mL	2 weeks after FET
Secondary	clinical pregnancy	presence of intrauterine gestational sac by trans-vaginal ultrasound at 6 gestational weeks.	6 weeks' gestation
Secondary	ongoing pregnancy	a viable pregnancy beyond 12 weeks' gestation	12 weeks' gestation
Secondary	implantation rate	the number of gestational sacs per blastocyst transferred	6 weeks' gestation
Secondary	miscarriage	a clinically recognized pregnancy loss before the 22 weeks of pregnancy	1 year after FET
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	birthweight of newborns	the birth weight of newborns	1 year after FET