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

Infertility, Female Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05632731
• Other study ID #: IRB-20220201-R
• Status: Not yet recruiting
• Phase: N/A
• Start date: December 2022
• Est. completion date: December 2024

Study information

• Verified date: November 2022
• Source: Women's Hospital School Of Medicine Zhejiang University
• Contact: Yimin Zhu, Dr
• Phone: 0571-89992071
• Email: zhuyim[@]zju.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 1236
• Est. completion date: December 2024
• Est. primary completion date: August 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 38 Years

Eligibility

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

Related Conditions & MeSH terms

• Infertility
• Infertility, Female

Intervention

Procedure:
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Women's Hospital School Of Medicine Zhejiang University	ORGANON (SHANGHAI) PHARMACEUTICAL TECHNOLOGY CO., LTD.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	live birth rate per fresh transfer	live birth, which was defined as the presence of a live fetus (or feti) after the 24th week of gestational age	2 year