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

April 12, 2011 updated by: Mansoura University

Letrozole and CC Alone in an IUI Program in Women With Surgically Treated Minimal to Mild Endometriosis

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

136

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
    • Dakahlia Governorate
      • Mansoura, Dakahlia Governorate, Egypt, 35511
        • Mansoura University Hospitals,OB/GYN department

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 36 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 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.
Drug: 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.
ACTIVE_COMPARATOR: 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.
Drug: CC/IUI
Patients received 100 mg lCC 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Clinical pregnancy rate per cycle
Time Frame: 6-7 weeks gestation
6-7 weeks gestation

Secondary Outcome Measures

Outcome Measure
Time Frame
Miscarriage rate.
Time Frame: Up to 20 weeks gestation
Up to 20 weeks gestation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mansoura University

Investigators

  • Study Chair: Mohamed El Rakhawy, MD, Mansoura University Hospital
  • Study Director: Ibrahim Abd Elaal, Mansoura University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2007

Primary Completion (ACTUAL)

June 1, 2010

Study Completion (ACTUAL)

June 1, 2010

Study Registration Dates

First Submitted

April 11, 2011

First Submitted That Met QC Criteria

April 12, 2011

First Posted (ESTIMATE)

April 13, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

April 13, 2011

Last Update Submitted That Met QC Criteria

April 12, 2011

Last Verified

April 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MU-157x
  • FMH-92-B

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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