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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Evaluating the Clinical Outcomes Following Transfer of Blastocysts Cultured From Thawed Cleavage Stage Embryos at Royan Institute: A Phase 3, Randomized Controlled Trial

Conditions
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Infertility

Intervention / Treatment
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* Procedure: Blastocyte Transferring
* Procedure: Embryo Transferring


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 37 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Blastocyst transplantation<br>The infertile women who underwent intra- uterus transferring of blastocyst from thawed cleavage embryo | Procedure: Blastocyte Transferring<br>* Intra-uterine transferring of blastocyst from thawed cleavage embryo in infertile women.<br>|
| Placebo Comparator: Control<br>The infertile women who underwent intra- uterus transferring of thawed cleavage embryo. | Procedure: Embryo Transferring<br>* Inta-uterine transferring of thawed cleavage embryo transfer in infertile women.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pregnancy Rate | Evaluation of pregnancy rate in women 4 weeks after embryos transfer (ET). | 4weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Miscarriage Rate | Evaluation the miscarriage rate in women 14 days after embryo transfer (ET) with BHCG titration. | 14 days | 
| Implantation Rate | Evaluation the implantation rate in women 14 days after embryo transfer (ET) with BHCG titration.. | 14 days | 
| Ongoing pregnancy rate | Evaluation the ongoing pregnancy rate in women 14 days after embryo transfer (ET) with BHCG titration.. | 14 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cleavage stage blastocyst transfer cryopreservation