Effect of Local Injury on Implantation

Implantation Rate Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00846183
• Other study ID #: local injury111
• Status: Completed
• Phase: Phase 2
• First received: February 17, 2009
• Last updated: December 20, 2013
• Start date: June 2008
• Est. completion date: June 2009

Study information

• Verified date: December 2013
• Source: Yazd Research & Clinical Center for Infertility
• Contact: n/a
• Is FDA regulated: No
• Health authority: Iran: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 156
• Est. completion date: June 2009
• Est. primary completion date: November 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A to 35 Years

Eligibility

Inclusion Criteria:

• Age < 35

• First IVF cycle

• Long protocol should be used for stimulation

Exclusion Criteria:

• Day 3 FSH > 10

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Implantation Rate

Intervention

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

Locations

Country	Name	City	State
Iran, Islamic Republic of	Research and clinical center for infertility	Yazd

Sponsors (1)

Lead Sponsor	Collaborator
Yazd Research & Clinical Center for Infertility

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	implantation rate		4 weeks	Yes
Secondary	clinical pregnancy rate		4 weeks	Yes