Endometrial Scratch Injury in Women With Unexplained Infertility Undergoing IUI

Not Applicable

Completed

• Conditions: Unexplained Infertility
• Interventions: Procedure: endometrial scratch injury

• Registration Number: NCT02349750
• Lead Sponsor: Cairo University

Brief Summary

The study included 154 infertile women Patients received 100 mg of oral clomiphene citrate for five days starting on day 3 of the menstrual cycle, followed by daily injection of 150 IU of hMG and when more than two dominant follicles reached a diameter of 17 mm 5,000 IU of hCG was injected intramuscularly. Patients were randomly allocated into two equal groups: Group C received IUI without ESI and Group S had ESI using No.8 neonatal feeding tube and after 24 to 36 hours, IUI was performed. Successful pregnancy was con-firmed by ultrasound and patients had failed trial underwent another trial of IUI for a maximum of three trials.

Detailed Description

The study included 154 infertile women with mean duration of infertility of 3.9±0.4 years. Patients received 100 mg of oral clomiphene citrate for five days starting on day 3 of the menstrual cycle, followed by daily injection of 150 IU of hMG and when more than two dominant follicles reached a diameter of 17 mm 5,000 IU of hCG was injected intramuscularly. Patients were randomly allocated into two equal groups: Group C received IUI without ESI and Group S had ESI using No.8 neonatal feeding tube and after 24 to 36 hours, IUI was performed. Successful pregnancy was con-firmed by ultrasound and patients had failed trial underwent another trial of IUI for a maximum of three trials.

Study Timeline

• Study Start: 2010-01
• Primary Completion: 2013-01
• Study Completion: 2013-01
• Status Verified: 2015-01
• Study First Submitted: 2015-01-24
• Study First Submitted QC: 2015-01-28
• Last Update Submitted: 2015-01-28
• Study First Posted: 2015-01-29
• Last Update Posted: 2015-01-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 154

Inclusion Criteria

1. Couple with unexplained infertility and assigned for IUI

Exclusion Criteria

1. Woman's age of more than 40 years
2. Ovarian cyst detected in the ultrasound examination
3. Uterine lesions such as submucosal leiomyoma
4. A previous diagnosis of moderate to severe pelvic endometriosis
5. Women with body mass index ≥35 kg/m2 o
6. Women with signs of hyperandrogenemia dy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
endometrial scratch injury	endometrial scratch injury	Patients received 100 mg of oral clomiphene citrate for five days starting on day 3 of the menstrual cycle, followed by daily injection of 150 IU of hMG and when more than two dominant follicles reached a diameter of 17 mm 5,000 IU of hCG was injected intramuscularly. Group S had ESI using No.8 neonatal feeding tube and after 24 to 36 hours, IUI was performed.

Primary Outcome Measures

Name	Time	Method
clinical pregnancy	14 days after IUI