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

This study has been completed.
Sponsor:
Information provided by:
Mansoura University
ClinicalTrials.gov Identifier:
NCT01334762
First received: April 11, 2011
Last updated: April 12, 2011
Last verified: April 2011
  Purpose

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


Condition Intervention
Endometriosis
Drug: Letrozole/IUI
Drug: CC/IUI

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Letrozole and CC Alone in an IUI Program in Women With Surgically Treated Minimal to Mild Endometriosis

Resource links provided by NLM:


Further study details as provided by Mansoura University:

Primary Outcome Measures:
  • Clinical pregnancy rate per cycle [ Time Frame: 6-7 weeks gestation ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Miscarriage rate. [ Time Frame: Up to 20 weeks gestation ] [ Designated as safety issue: No ]

Enrollment: 136
Study Start Date: May 2007
Study Completion Date: June 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   20 Years to 36 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01334762

Locations
Egypt
Mansoura University Hospitals,OB/GYN department
Mansoura, Dakahlia Governorate, Egypt, 35511
Sponsors and Collaborators
Mansoura University
Investigators
Principal Investigator: Hatem Abu Hashim, MD MRCOG Mansoura University Hospitals
Study Chair: Mohamed El Rakhawy, MD Mansoura University Hospitals
Study Director: Ibrahim Abd Elaal Mansoura University Hospitals
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Dr. Hatem Abu Hashim, Associate Prof. of OB/GYN, Mansoura Faculty of Medicine, Mansoura University.
ClinicalTrials.gov Identifier: NCT01334762     History of Changes
Other Study ID Numbers: MU-157x, FMH-92-B
Study First Received: April 11, 2011
Last Updated: April 12, 2011
Health Authority: Egypt: Institutional Review Board

Keywords provided by Mansoura University:
minimal to mild endometriosis
letrozole
clomiphene citrate
IUI

Additional relevant MeSH terms:
Endometriosis
Genital Diseases, Female
Letrozole
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Aromatase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 18, 2014