Clinical trial NCT03201783: Immediate Versus Delayed FET Following a Stimulated IVF Cycle
Official title: A Randomized Trial Comparing the Effect of Immediate Versus Delayed Frozen-thawed Embryo Transfer Following a Stimulated IVF Cycle
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fertilization in Vitro
Embryo Transfer
Keywords: frozen-thawed embryo transfer
time interval
Lead sponsor: ShangHai Ji Ai Genetics & IVF Institute
Sponsor class: OTHER
Collaborators: name: The University of Hong Kong
First posted: 2017-06-28
Enrollment: 724
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 43
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: ongoing pregnancy
timeFrame: viable pregnancy beyond gestation 12 weeks
Secondary outcomes:
measure: Positive hCG level
timeFrame: A blood pregnancy test is performed 14 days after the FET
measure: clinical pregnancy
timeFrame: presence of intrauterine gestational sac on ultrasound at 6 weeks of pregnancy
measure: biochemical pregnancy:
timeFrame: positive blood pregnancy test not followed by clinical pregnancy during 12 weeks gestation
measure: implantation rate
timeFrame: number of gestational sacs per embryo transferred during 4 weeks of pregnancy
measure: multiple pregnancy
timeFrame: multiple pregnancy beyond gestation 12 weeks
measure: ectopic pregnancy
timeFrame: ectopic pregnancy during 12 weeks gestation
measure: miscarriage
timeFrame: the loss of a pregnancy before 22 weeks gestation
measure: live birth rate
timeFrame: a live birth after 22 weeks gestation
measure: birth weight
timeFrame: a live birth after 22 weeks gestation
Other outcomes:
Locations:
city: Shanghai
country: China
facility: ShangHai JIAI Genetics&IVF Institute
Study officials:
affiliation: Shanghai JiAi Genetics & IVF Institute
name: XIAOXI SUN, PHD
role: PRINCIPAL_INVESTIGATOR
References:
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: 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: 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: 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.
citation: 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.