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

Primary Purpose

Infertility

Status

Completed

Phase

Phase 3

Locations

Iran, Islamic Republic of

Study Type

Interventional

Intervention

Blastocyte Transferring

Embryo Transferring

About this trial

This is an interventional treatment trial for Infertility focused on measuring Cleavage stage blastocyst transfer cryopreservation

Eligibility Criteria

16 Years - 37 Years (Child, Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

Royan Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Blastocyst transplantation

Control

Arm Description

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

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

Outcomes

Primary Outcome Measures

Pregnancy Rate

Evaluation of pregnancy rate in women 4 weeks after embryos transfer (ET).

Secondary Outcome Measures

Miscarriage Rate

Evaluation the miscarriage rate in women 14 days after embryo transfer (ET) with BHCG titration.

Implantation Rate

Evaluation the implantation rate in women 14 days after embryo transfer (ET) with BHCG titration..

Ongoing pregnancy rate

Evaluation the ongoing pregnancy rate in women 14 days after embryo transfer (ET) with BHCG titration..

Full Information

NCT ID

NCT02681029

First Posted

February 2, 2016

Last Updated

May 8, 2021

Sponsor

Royan Institute

1. Study Identification

Unique Protocol Identification Number

NCT02681029

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2016

Overall Recruitment Status

Completed

Study Start Date

November 2015 (undefined)

Primary Completion Date

July 2020 (Actual)

Study Completion Date

September 27, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Royan Institute

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Infertility

Keywords

Cleavage stage blastocyst transfer cryopreservation

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

220 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Blastocyst transplantation

Arm Type

Experimental

Arm Description

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

Arm Title

Control

Arm Type

Placebo Comparator

Arm Description

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

Intervention Type

Procedure

Intervention Name(s)

Blastocyte Transferring

Intervention Description

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

Intervention Type

Procedure

Intervention Name(s)

Embryo Transferring

Intervention Description

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

Primary Outcome Measure Information:

Title

Pregnancy Rate

Description

Evaluation of pregnancy rate in women 4 weeks after embryos transfer (ET).

Time Frame

4weeks

Secondary Outcome Measure Information:

Title

Miscarriage Rate

Description

Evaluation the miscarriage rate in women 14 days after embryo transfer (ET) with BHCG titration.

Time Frame

14 days

Title

Implantation Rate

Description

Evaluation the implantation rate in women 14 days after embryo transfer (ET) with BHCG titration..

Time Frame

14 days

Title

Ongoing pregnancy rate

Description

Evaluation the ongoing pregnancy rate in women 14 days after embryo transfer (ET) with BHCG titration..

Time Frame

14 days

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

16 Years

Maximum Age & Unit of Time

37 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Hamid Gourabi, PhD

Organizational Affiliation

Head of Royan Institute

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Tahereh Madani, MD

Organizational Affiliation

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

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Poopak Eftekhari-Yazdi, PhD

Organizational Affiliation

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

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Nadia Jahangiri, MSc

Organizational Affiliation

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

Official's Role

Principal Investigator

Facility Information:

Facility Name

Royan Institute

City

Tehran

Country

Iran, Islamic Republic of

12. IPD Sharing Statement

Links:

URL

http://Royaninstitute.org

Description

Related Info

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

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