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

Mansoura University

Status: Completed

Conditions: Endometriosis

Treatments: Drug: Letrozole/IUI; Drug: CC/IUI

Study type: Interventional

Funder types: Other

Identifiers

NCT01334762

MU-157x

FMH-92-B

Details and patient eligibility

About

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

Enrollment: 136 patients

Sex: Female

Ages: 20 to 36 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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136 participants in 2 patient groups

Letrozole/IUI

Experimental group

Description:

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.

Treatment:

Drug: Letrozole/IUI

CC/IUI

Active Comparator group

Description:

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.

Treatment:

Drug: CC/IUI