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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Immediate FET group | Other | FET will be performed in the first menstrual cycle following the stimulated IVF cycle |
|
| Delayed FET group | Other | FET will be performed in the second menstrual cycle following the stimulated IVF cycle |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Immediate FET | Procedure | FET is performed in the first menstrual cycle following the stimulated IVF cycle |
|
| Measure | Description | Time Frame |
|---|---|---|
| live birth | deliveries ≥22 weeks gestation with heartbeat and breath | 1 year after FET |
| Measure | Description | Time Frame |
|---|---|---|
| positive hCG | serum β-hCG ≥10 mIU/mL | 2 weeks after FET |
| clinical pregnancy | presence of intrauterine gestational sac by trans-vaginal ultrasound at 6 gestational weeks. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Xiaoxi Sun, Phd | Shanghai JiAi Genetics & IVF Institute | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai JiAi Genetics & IVF Institute | Shanghai | Shanghai Municipality | 200011 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24907917 | Background | 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. | |
| 21737072 | Background | 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. |
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Individual participant data that underlie the results after deidentification (text, tables, figures, and appendices) and study protocol will be shared.
Data will be available when beginning 3 months and ending 5 years following article publication.
To achieve aims in the approved proposal, researchers who provide a methodologically sound proposal will be shared with. Proposals should be directed to lihe198900@163.com.
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| Delayed FET | Procedure | FET is performed in the second menstrual cycle following the stimulated IVF cycle |
|
| 6 weeks' gestation |
| ongoing pregnancy | a viable pregnancy beyond 12 weeks' gestation | 12 weeks' gestation |
| implantation rate | the number of gestational sacs per blastocyst transferred | 6 weeks' gestation |
| miscarriage | a clinically recognized pregnancy loss before the 22 weeks of pregnancy | 1 year after FET |
| multiple pregnancy | more than one intrauterine sacs on scanning | multiple pregnancy beyond gestation 12 weeks |
| ectopic pregnancy | pregnancy outside the uterine cavity | ectopic pregnancy during 12 weeks gestation |
| birthweight of newborns | the birth weight of newborns | 1 year after FET |
| 25586787 | Background | 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. |
| 27609984 | 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. |
| 26806686 | Background | 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. |
| 27986819 | 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. |
| 28041829 | 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. |
| 28905357 | Background | 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. |
| 38719320 | Derived | Li H, Zhang W, Chen J, Lu X, Li L, Sun X, Ng EH. Immediate versus delayed single blastocyst transfer following the first stimulated IVF cycle in the freeze-all strategy: a study protocol for a randomised controlled trial. BMJ Open. 2024 May 8;14(5):e081018. doi: 10.1136/bmjopen-2023-081018. |