Does Local Injury of the Endometrium Improve Controlled Ovarian Hyperstimulation (COH) + Intrauterine Insemination (IUI) Outcome?

Not Applicable

• Conditions: Infertility; Implantation Failure
• Interventions: Procedure: endometrial biopsy; Procedure: natural cycle + IUI + endometrial biopsy

• Registration Number: NCT01111799
• Lead Sponsor: Meir Medical Center

Brief Summary

It was previously demonstrated in in vitro fertilization (IVF) patients that local injury of the endometrium during a spontaneous menstrual cycle that precedes IVF treatment doubled the rates of implantation and pregnancy. The hypothesis of our present study is that the endometrial injury procedure will have the same beneficial effect in patients undergoing controlled ovarian hyperstimulation (COH) combined with intrauterine insemination (IUI).

Detailed Description

In order to test our hypothesis, we will perform the simple procedure of local injury of the endometrium using a "Pipelle" biopsy catheter during the spontaneous menstrual cycle that precedes a COH + IUI treatment.

Study Timeline

• Study First Submitted: 2010-04-21
• Study First Submitted QC: 2010-04-26
• Study First Posted: 2010-04-28
• Study Start: 2010-06
• Status Verified: 2012-03
• Last Update Submitted: 2012-03-15
• Last Update Posted: 2012-03-16
• Primary Completion: 2012-09
• Study Completion: 2012-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 600

Inclusion Criteria

• age 18-38.
• infertility.
• patients undergoing IUI treatment.
• at least one failed IUI cycle.

Exclusion Criteria

• indication for IVF treatment.
• Known Pelvic inflammatory disease(PID).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Clomiphene citrate + IUI + endometrial biopsy	endometrial biopsy	Clomiphene citrate + IUI + endometrial biopsy
gonadotrophines + IUI + endometrial biopsy	endometrial biopsy	two endometrial biopsies will be taken with a PIPELLE catheter on days 12 and 21 of the spontaneous menstrual cycle that precedes the fertility treatment.
natural cycle + IUI + endometrail biopsy	natural cycle + IUI + endometrial biopsy	two endometrial biopsies will be taken with a PIPELLE catheter on days 12 and 21 of the spontaneous menstrual cycle that precedes the fertility treatment.

Primary Outcome Measures

Name	Time	Method
Clinical Pregnancy rate	1 year

Secondary Outcome Measures

Name	Time	Method
Live birth	2 years

Trial Locations

Locations (1)

Remez women medical center; 🇮🇱 Rehovot, Israel