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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

220 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-11-30

Study Completion Date

2020-09-27

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.

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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.

Conditions

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Infertility

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Blastocyst transplantation

The infertile women who underwent intra- uterus transferring of blastocyst from thawed cleavage embryo

Group Type EXPERIMENTAL

Blastocyte Transferring

Intervention Type PROCEDURE

Intra-uterine transferring of blastocyst from thawed cleavage embryo in infertile women.

Control

The infertile women who underwent intra- uterus transferring of thawed cleavage embryo.

Group Type PLACEBO_COMPARATOR

Embryo Transferring

Intervention Type PROCEDURE

Inta-uterine transferring of thawed cleavage embryo transfer in infertile women.

Interventions

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Blastocyte Transferring

Intra-uterine transferring of blastocyst from thawed cleavage embryo in infertile women.

Intervention Type PROCEDURE

Embryo Transferring

Inta-uterine transferring of thawed cleavage embryo transfer in infertile women.

Intervention Type PROCEDURE

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

Minimum Eligible Age

16 Years

Maximum Eligible Age

37 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Hamid Gourabi, PhD

Role: STUDY_CHAIR

Head of Royan Institute

Tahereh Madani, MD

Role: STUDY_DIRECTOR

Department of Endocrinology and Female Infertility, Reproductive Biomedicine Research Center, Royan Institute for Reproductive Biomedicine, ACECR, Tehran, Iran

Poopak Eftekhari-Yazdi, PhD

Role: PRINCIPAL_INVESTIGATOR

Department of Endocrinology and Female Infertility, Reproductive Biomedicine Research Center, Royan Institute for Reproductive Biomedicine, ACECR, Tehran, Iran

Nadia Jahangiri, MSc

Role: PRINCIPAL_INVESTIGATOR

Department of Endocrinology and Female Infertility, Reproductive Biomedicine Research Center, Royan Institute for Reproductive Biomedicine, ACECR, Tehran, Iran