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

NCT ID: NCT04371783

Last Updated: 2025-05-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

828 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-05-04

Study Completion Date

2026-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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IVF Frozen Embryo Transfer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Immediate FET group

FET will be performed in the first menstrual cycle following the stimulated IVF cycle

Group Type OTHER

Immediate FET

Intervention Type PROCEDURE

FET is performed in the first menstrual cycle following the stimulated IVF cycle

Delayed FET group

FET will be performed in the second menstrual cycle following the stimulated IVF cycle

Group Type OTHER

Delayed FET

Intervention Type PROCEDURE

FET is performed in the second menstrual cycle following the stimulated IVF cycle

Interventions

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Immediate FET

FET is performed in the first menstrual cycle following the stimulated IVF cycle

Intervention Type PROCEDURE

Delayed FET

FET is performed in the second menstrual cycle following the stimulated IVF cycle

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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ShangHai Ji Ai Genetics & IVF Institute

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Xiaoxi Sun, Phd

Role: STUDY_DIRECTOR

Shanghai JiAi Genetics & IVF Institute

Locations

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Shanghai JiAi Genetics & IVF Institute

Shanghai, Shanghai Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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HE LI, MD

Role: CONTACT

+8602163459977

Facility Contacts

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HE LI, MD

Role: primary

+8602163459977

References

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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.

Reference Type BACKGROUND
PMID: 24907917 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21737072 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25586787 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27609984 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26806686 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27986819 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28041829 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28905357 (View on PubMed)

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.

Reference Type DERIVED
PMID: 38719320 (View on PubMed)

Other Identifiers

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JIAI 2020-04

Identifier Type: -

Identifier Source: org_study_id

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