Effect of Local Injury on Implantation

Sponsor

Yazd Research & Clinical Center for Infertility (Other)

Overall Status

Completed

CT.gov ID

NCT00846183

Collaborator

(none)

156

Enrollment

Location

Arms

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Local injury on two sights of endometrium are performed in 60 patients in their first IVF cycle and implantation rate are compared with fresh cycles without local injury.

Condition or Disease	Intervention/Treatment	Phase
Implantation Rate	Procedure: local injury	Phase 2

Detailed Description

Low implantation rate is still a major concern in ART cycles. It has been reported that local injury to endometrium may improve endometrial receptivity and implantation rate. A total of 120 patients in first IVF cycles, who are stimulated with long protocol, are randomly divided into two groups. In one group, on the day of oocyte retrieval, local injury to endometrium with a Novak curet to anterior and posterior wall of endometrium are performed and in the other group no interventions are done. After fresh embryo transfers, implantation and clinical pregnancy rates are compared between two groups.

Study Design

Study Type:

Interventional

Actual Enrollment :

156 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Effect of Local Injury to Endometrium on the Day of Oocyte Retrieval in First IVF Cycle on Implantation Rate.

Study Start Date :

Jun 1, 2008

Actual Primary Completion Date :

Nov 1, 2008

Actual Study Completion Date :

Jun 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: local ingury In one group, on the day of oocyte retrieval, local injury to endometrium with a Novak curet to anterior and posterior wall of endometrium are performed.	Procedure: local injury In one group, on the day of oocyte retrieval, local injury to endometrium with a Novak curet to anterior and posterior wall of endometrium are performed Other Names: it does not have other name
No Intervention: control in 60 patients routine IVF are performed

Arm

Intervention/Treatment

Active Comparator: local ingury

In one group, on the day of oocyte retrieval, local injury to endometrium with a Novak curet to anterior and posterior wall of endometrium are performed.

Procedure: local injury

In one group, on the day of oocyte retrieval, local injury to endometrium with a Novak curet to anterior and posterior wall of endometrium are performed

Other Names:

it does not have other name

No Intervention: control

in 60 patients routine IVF are performed

Outcome Measures

Primary Outcome Measures

implantation rate [4 weeks]

Secondary Outcome Measures

clinical pregnancy rate [4 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A to 35 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Age < 35
First IVF cycle
Long protocol should be used for stimulation

Exclusion Criteria:

Day 3 FSH > 10

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Research and clinical center for infertility	Yazd		Iran, Islamic Republic of

Sponsors and Collaborators

Yazd Research & Clinical Center for Infertility

Investigators

Principal Investigator: homa oskouian, M.D., Research and clinical center for infertility
Principal Investigator: Mohamad ali karimzade, MD, Research and clinical center for infertility