Comparison of 5 Day Embryo Transfer With 2-3 Day Transfer... | NCT01107002

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

NCT01107002

Sponsor

Royan Institute

Status

Completed

Last Update Posted

Jul 15, 2011Estimated

Enrollment

200Actual

Phase

Phase 1Phase 2

Conditions

Infertility

Interventions

Day 5 embryo transfer group

Countries

Iran

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2010

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2008

Primary Completion Date

May 2010Actual

Completion Date

Aug 2010Actual

First Submitted Date

Apr 17, 2010

First Submission Date that Met QC Criteria

Apr 19, 2010

First Posted Date

Apr 20, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 14, 2011

Last Update Posted Date

Jul 15, 2011Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

200Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Day 5 embryo transfer group	Experimental	Embryo will transfer at blastocyst stage (day 5 after ovum pick up)	Procedure: Day 5 embryo transfer group

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Day 5 embryo transfer group	Procedure	Embryo will transfer at blastocyst stage (day 5 after ovum pick up)	Day 5 embryo transfer group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Clinical Pregnancy rate		6-8 weeks after oocyte retrieval
Live birth rate		After 37 weeks of gestational age

Secondary Outcomes

Measure	Description	Time Frame
Implantation rate		4 weeks after embryo transfer
Miscarriage rate		18 weeks after fertilization

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

40 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Mahnaz Ashrafi,, MD	Royan Institute	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Royan Institute		Tehran		19395-4644	Iran

Label	URL
Related Info	View source

Condition Browse Module

MeSH Terms

ID	Term
D007246	Infertility

Ancestor Terms

ID	Term
D000091662	Genital Diseases
D000091642	Urogenital Diseases

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Browse Branches

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