The Clinical Outcomes Following Transfer of Blastocysts Cultured From Thawed Cleavage Stage Embryos

Phase 3

Completed

• Conditions: Infertility
• Interventions: Procedure: Blastocyte Transferring; Procedure: Embryo Transferring

• Registration Number: NCT02681029
• Lead Sponsor: Royan Institute

Brief Summary

Recent improvements in cell culture systems have led to a shift in in vitro fertilization (IVF) practice from early cleavage stage embryo transfer (ET) to blastocyst transfer. Blastocyst culture and transfer could theoretically provide better synchronization between the embryo and the uterine endometrium. The purpose of this study is comparing pregnancy rates and implantation rate following transfer of thawed cleavage embryos and blastocysts cultured from thawed cleavage embryos.

Detailed Description

The proposal of this study approved by our institutional review boards and institution's ethical committee, and all participants will sign a written consent before enter to study. All patients will be randomly divided into two groups of thawed cleavage embryo transfers and transfers of blastocysts from thawed cleavage embryos. Embryos will be transferred in hormone replacement cycles. Preparation of the endometrium will be started in the second day of menstruation and will be continued according to their transfer type (blastocyst or cleavage). βhCG will be assessed 14 days after embryo transfer. Treatment cycle outcomes will be compared between 2 groups.

Study Timeline

• Study Start: 2015-11
• Status Verified: 2016-02
• Study First Submitted: 2016-02-02
• Study First Submitted QC: 2016-02-09
• Study First Posted: 2016-02-12
• Primary Completion: 2020-07
• Study Completion: 2020-09-27
• Last Update Submitted: 2021-05-08
• Last Update Posted: 2021-05-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 220

Inclusion Criteria

• The patients with first type of infertility
• Age ≤ 37 years
• Long ovulation induction protocol

Exclusion Criteria

• Any previous surgery on the uterus and ovaries
• Uterine factor infertility
• Sever Male factor infertility (TESE, TESA ،Oligoteratozoospermia)
• Recurrent abortion
• The women with poor ovarian reserve

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Blastocyst transplantation	Blastocyte Transferring	The infertile women who underwent intra- uterus transferring of blastocyst from thawed cleavage embryo
Control	Embryo Transferring	The infertile women who underwent intra- uterus transferring of thawed cleavage embryo.

Primary Outcome Measures

Name	Time	Method
Pregnancy Rate	4weeks	Evaluation of pregnancy rate in women 4 weeks after embryos transfer (ET).

Secondary Outcome Measures

Name	Time	Method
Implantation Rate	14 days	Evaluation the implantation rate in women 14 days after embryo transfer (ET) with BHCG titration..
Ongoing pregnancy rate	14 days	Evaluation the ongoing pregnancy rate in women 14 days after embryo transfer (ET) with BHCG titration..
Miscarriage Rate	14 days	Evaluation the miscarriage rate in women 14 days after embryo transfer (ET) with BHCG titration.

Trial Locations

Locations (1)

Royan Institute; 🇮🇷 Tehran, Iran, Islamic Republic of