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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Infertility, Female
• Intervention / Treatment: Procedure: double cleavage-stage or single blastocyst stage embryos transfer

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 Type: Interventional
• Enrollment (Anticipated): 1236
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yimin Zhu, Dr; Phone Number: 0571-89992071; Email: zhuyim@zju.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 38 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Double Cleavage-stage Embryos transfer; In group A, two embryos at cleavage stage were transplanted on the third day after oocyte retrieval.	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.
Other: 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Anticipated): December 1, 2022
• Primary Completion (Anticipated): August 1, 2024
• Study Completion (Anticipated): December 1, 2024

Study Registration Dates

• First Submitted: November 20, 2022
• First Submitted That Met QC Criteria: November 20, 2022
• First Posted (Actual): December 1, 2022

Study Record Updates

• Last Update Posted (Actual): December 1, 2022
• Last Update Submitted That Met QC Criteria: November 20, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infertility; Infertility, Female
• Other Study ID Numbers: IRB-20220201-R

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No