Efficacy of Letrozole and CC Alone in an IUI Program in Cases With Surgically Treated Minimal to Mild Endometriosis

Not Applicable

Completed

• Conditions: Endometriosis
• Interventions: Drug: Letrozole/IUI; Drug: CC/IUI

• Registration Number: NCT01334762
• Lead Sponsor: Mansoura University

Brief Summary

To evaluate pregnancy rates with letrozole and CC alone in an IUI program for women with recently surgically treated minimal to mild endometriosis.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-05
• Primary Completion: 2010-06
• Study Completion: 2010-06
• Status Verified: 2011-04
• Study First Submitted: 2011-04-11
• Study First Submitted QC: 2011-04-12
• Last Update Submitted: 2011-04-12
• Study First Posted: 2011-04-13
• Last Update Posted: 2011-04-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 136

Inclusion Criteria

• Patient with minimal-mild endometriosis recently treated by laparoscopy with a waiting period of 6 to 12 months following the procedure
• No other infertility factors.
• Normal serum basal hormone levels as well as documented ovulation

Exclusion Criteria

• Moderate or severe endometriosis
• Dense adnexal and/or ovarian adhesions due to pelvic inflammatory disease or previous pelvic surgery
• Age more than 36 years, BMI more than 30 kg/m2
• women with a previous pregnancy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Letrozole/IUI	Letrozole/IUI	Patients received 5 mg letrozole daily for 5 days. A single insemination was performed 32-36 hours after hCG (10,000 IU, IM). Patients underwent up to four cycles of treatment.
CC/IUI	CC/IUI	Patients received 100 mg CC daily for 5 days. A single insemination was performed 32-36 hours after hCG (10,000 IU, IM). Patients underwent up to four cycles of treatment.

Primary Outcome Measures

Name	Time	Method
Clinical pregnancy rate per cycle	6-7 weeks gestation

Secondary Outcome Measures

Name	Time	Method
Miscarriage rate.	Up to 20 weeks gestation

Trial Locations

Locations (1)

Mansoura University Hospitals,OB/GYN department; 🇪🇬 Mansoura, Dakahlia Governorate, Egypt