Comparison of Clinical Outcomes in Fresh Cycle With Single Blastocyst Stage and Double Cleavage-stage Embryos: a Single-center, Non-blind, Randomized Controlled Study

Not Applicable

Not yet recruiting

• Conditions: Infertility, Female
• Interventions: Procedure: double cleavage-stage or single blastocyst stage embryos transfer

• Registration Number: NCT05632731
• Lead Sponsor: Women's Hospital School Of Medicine Zhejiang University

Brief Summary

In traditional assisted reproductive technology (ART), choosing multiple embryo transfer to get a high clinical pregnancy rate while increasing the risk of multiple pregnancies. Research showed that the single-cleavage embryo transfer could not simultaneously meet the dual requirements of maintaining pregnancy rate and reducing the multiple pregnancy rate.The purpose of this study was to observe the clinical outcome between double cleavage embryo transfers and single blastocyst transfers in fresh cycle through RCT study with GnRH antagonist protocol.

Detailed Description

In traditional assisted reproductive technology (ART), choosing multiple embryo transfer to get a high clinical pregnancy rate while increasing the risk of multiple pregnancies. Research showed that in the fresh cleavage embryo transfer cycle, the clinical pregnancy rate increased with the increase of the number of high-quality embryos transferred, and so did the multiple pregnancy rate, suggesting that the single-cleavage embryo transfer could not simultaneously meet the dual requirements of maintaining pregnancy rate and reducing the multiple pregnancy rate. Compared with the embryo at cleavage stage, blastocyst culture is a process of survival of the fittest, which is physiologically more synchronized with endometrial development and can improve embryo implantation rate.

The existing clinical research analysis is mostly limited to the down-regulating regimen, while the RCT study of high-quality with GnRH antagonist protocol is few. Therefore, the purpose of this study was to observe the clinical outcome between double cleavage embryo transfers and single blastocyst transfers in fresh cycle through RCT study with GnRH antagonist protocol.

Study Timeline

• Status Verified: 2022-11
• Study First Submitted: 2022-11-20
• Study First Submitted QC: 2022-11-20
• Last Update Submitted: 2022-11-20
• Study Start: 2022-12
• Study First Posted: 2022-12-01
• Last Update Posted: 2022-12-01
• Primary Completion: 2024-08
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 1236

Inclusion Criteria

1. patients with a diagnosis of primary or secondary infertility with a clinical indication for IVF/intracytoplasmic sperm injection (ICSI)
2. under 38 years of age
3. number of AFC≥6, AMH>1.1ng/ml
4. no adverse factors of fresh embryo transplantation (evaluation by an experienced reproductive physician)
5. number of available embryos(day 3)≥4
6. informed consent

Exclusion Criteria

1. PGT
2. with adenomyosis, endometrial compression by uterine fibroids, intrauterine adhesion, endometrial polyps and other factors unsuitable for fresh cycle transplantation

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Single Blastocyst Stage Embryos transfer	double cleavage-stage or single blastocyst stage embryos transfer	Group B was graded by Gardner blastocyst grading method, and one blastocyst was transplanted on the 5th or 6th day after oocyte retrieval.
Double Cleavage-stage Embryos transfer	double cleavage-stage or single blastocyst stage embryos transfer	In group A, two embryos at cleavage stage were transplanted on the third day after oocyte retrieval.

Primary Outcome Measures

Name	Time	Method
live birth rate per fresh transfer	2 year	live birth, which was defined as the presence of a live fetus (or feti) after the 24th week of gestational age