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

NCT ID: NCT05632731

Last Updated: 2022-12-01

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 1236 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-12-31
• Study Completion Date: 2024-12-31

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.

Conditions

Infertility, Female

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Double Cleavage-stage Embryos transfer

In group A, two embryos at cleavage stage were transplanted on the third day after oocyte retrieval.

Group Type: OTHER

double cleavage-stage or single blastocyst stage embryos transfer

Intervention Type: PROCEDURE

Infertile women requesting in vitro fertilization treatment were randomly assigned to undergo transfer of either two cleavage-stage embryos or a single blastocyst-stage embryo.

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.

Group Type: OTHER

double cleavage-stage or single blastocyst stage embryos transfer

Intervention Type: PROCEDURE

Infertile women requesting in vitro fertilization treatment were randomly assigned to undergo transfer of either two cleavage-stage embryos or a single blastocyst-stage embryo.

Interventions

double cleavage-stage or single blastocyst stage embryos transfer

Infertile women requesting in vitro fertilization treatment were randomly assigned to undergo transfer of either two cleavage-stage embryos or a single blastocyst-stage embryo.

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 38 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

ORGANON (SHANGHAI) PHARMACEUTICAL TECHNOLOGY CO., LTD.

UNKNOWN

Sponsor Role: collaborator

Women's Hospital School Of Medicine Zhejiang University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Yimin Zhu, Dr

Role: CONTACT

zhuyim@zju.edu.cn

0571-89992071

Other Identifiers

IRB-20220201-R

Identifier Type: -

Identifier Source: org_study_id