Clinical trial NCT04371783: A Randomized Trial Comparing the Live Birth Rate of Immediate Versus Delayed FET Following a Freeze-all Strategy
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: IVF
Frozen Embryo Transfer
Lead sponsor: ShangHai Ji Ai Genetics & IVF Institute
Sponsor class: OTHER
First posted: 2020-05-01
Enrollment: 828
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: live birth
timeFrame: 1 year after FET
Secondary outcomes:
measure: positive hCG
timeFrame: 2 weeks after FET
measure: clinical pregnancy
timeFrame: 6 weeks' gestation
measure: ongoing pregnancy
timeFrame: 12 weeks' gestation
measure: implantation rate
timeFrame: 6 weeks' gestation
measure: miscarriage
timeFrame: 1 year after FET
measure: multiple pregnancy
timeFrame: multiple pregnancy beyond gestation 12 weeks
measure: ectopic pregnancy
timeFrame: ectopic pregnancy during 12 weeks gestation
measure: birthweight of newborns
timeFrame: 1 year after FET
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai JiAi Genetics & IVF Institute
state: Shanghai
Study officials:
affiliation: Shanghai JiAi Genetics & IVF Institute
name: Xiaoxi Sun, Phd
role: STUDY_DIRECTOR
References:
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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.
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.
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.
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.
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.
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.