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Comparison of 5 Day Embryo Transfer With 2-3 Day Transfer in Patients With Previous In Vitro Fertilization Failure

Primary Purpose

Infertility

Status

Completed

Phase

Phase 1

Locations

Iran, Islamic Republic of

Study Type

Interventional

Intervention

Day 5 embryo transfer group

About this trial

This is an interventional treatment trial for Infertility focused on measuring infertility, Embryo transfer

Eligibility Criteria

18 Years - 40 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

Age fewer than 40
Normal uterine cavity and patent tubes by either hysterosalpingogram or laparoscopy and hysteroscopy
Two previous or more failed IVF/ICSI cycles

Exclusion Criteria:

Women with submucous myoma
Women with intra mural or subserous myoma greater than 3 cm
Women with Endometriosis or Endometrioma
Hydrosalpinx

Sites / Locations

Royan Institute

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Day 5 embryo transfer group

Arm Description

Embryo will transfer at blastocyst stage (day 5 after ovum pick up)

Outcomes

Primary Outcome Measures

Clinical Pregnancy rate

Live birth rate

Secondary Outcome Measures

Implantation rate

Miscarriage rate

Full Information

NCT ID

NCT01107002

First Posted

April 17, 2010

Last Updated

July 14, 2011

Sponsor

Royan Institute

1. Study Identification

Unique Protocol Identification Number

NCT01107002

Brief Title

Comparison of 5 Day Embryo Transfer With 2-3 Day Transfer in Patients With Previous In Vitro Fertilization Failure

Official Title

Comparison of 5 Day Embryo Transfer With 2-3 Day Transfer in Patients Who Failed to Conceive in Two or More Day 2-3 Embryo Transfer Cycle in Royan Institute

Study Type

Interventional

2. Study Status

Record Verification Date

April 2010

Overall Recruitment Status

Completed

Study Start Date

July 2008 (undefined)

Primary Completion Date

May 2010 (Actual)

Study Completion Date

August 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Royan Institute

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The purpose of this study is to determine whether embryo transfer on day 3 versus day 5 shows a significant difference in implantation, clinical pregnancy, live birth, miscarriage and multiple pregnancy rates among women with at least two previous IVF failures

Detailed Description

A total of 200 infertile women with at least two previous IVF failures will enroll in this prospective randomized clinical trial study and will randomly be divided into two groups. Random permuted blocks with a block size of 4 will be used to ensure randomization and complete allocation concealment. The study protocol will be assessed by an independent institutional review board and Royan ethics committee. Ovarian stimulation protocol will include the use of a GnRH agonist (Superfact; Aventis Pharma Deutshlan, Frankfurt, Germany) administered in the long (down-regulation) protocol and the subsequent addition of FSH (Gonal F, Sereno, Switzerland). Embryos will be initially cultured in G1.V5 medium) Vitrolife-Sweden)TM on day 1 and 2, being transferred from this medium to G2.V5 ) Vitrolife-Sweden)TM on day 3. Embryos will be transferred on day 5, depending on the degree of expansion of the blastocyst. Main outcome measures will be implantation, clinical pregnancy and live birth rates.

6. Conditions and Keywords

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

Infertility

Keywords

infertility, Embryo transfer

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Single Group Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

200 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Day 5 embryo transfer group

Arm Type

Experimental

Arm Description

Embryo will transfer at blastocyst stage (day 5 after ovum pick up)

Intervention Type

Procedure

Intervention Name(s)

Day 5 embryo transfer group

Intervention Description

Embryo will transfer at blastocyst stage (day 5 after ovum pick up)

Primary Outcome Measure Information:

Title

Clinical Pregnancy rate

Time Frame

6-8 weeks after oocyte retrieval

Title

Live birth rate

Time Frame

After 37 weeks of gestational age

Secondary Outcome Measure Information:

Title

Implantation rate

Time Frame

4 weeks after embryo transfer

Title

Miscarriage rate

Time Frame

18 weeks after fertilization

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

40 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Age fewer than 40 Normal uterine cavity and patent tubes by either hysterosalpingogram or laparoscopy and hysteroscopy Two previous or more failed IVF/ICSI cycles Exclusion Criteria: Women with submucous myoma Women with intra mural or subserous myoma greater than 3 cm Women with Endometriosis or Endometrioma Hydrosalpinx

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Mahnaz Ashrafi,, MD

Organizational Affiliation

Royan Institute

Official's Role

Principal Investigator

Facility Information:

Facility Name

Royan Institute

City

Tehran

ZIP/Postal Code

19395-4644

Country

Iran, Islamic Republic of

12. IPD Sharing Statement

Links:

URL

http://www.royaninstitute.org

Description

Related Info

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Comparison of 5 Day Embryo Transfer With 2-3 Day Transfer in Patients With Previous In Vitro Fertilization Failure

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