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

Women's Hospital School Of Medicine Zhejiang University

Status: Not yet enrolling

Conditions: Infertility, Female

Treatments: Procedure: double cleavage-stage or single blastocyst stage embryos transfer

Study type: Interventional

Funder types: Other

Identifiers

NCT05632731

IRB-20220201-R

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,236 estimated patients

Sex: Female

Ages: 18 to 38 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

1,236 participants in 2 patient groups

Double Cleavage-stage Embryos transfer

Other group

Description:

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

Treatment:

Procedure: double cleavage-stage or single blastocyst stage embryos transfer

Single Blastocyst Stage Embryos transfer

Other group

Description:

Group B was graded by Gardner blastocyst grading method, and one blastocyst was transplanted on the 5th or 6th day after oocyte retrieval.

Treatment:

Procedure: double cleavage-stage or single blastocyst stage embryos transfer