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

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ClinicalTrials.gov Identifier: NCT01334762
Recruitment Status : Completed
First Posted : April 13, 2011
Last Update Posted : April 13, 2011
Sponsor:
Information provided by:
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.

Condition or disease Intervention/treatment
Endometriosis Drug: Letrozole/IUI Drug: CC/IUI

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 136 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Letrozole and CC Alone in an IUI Program in Women With Surgically Treated Minimal to Mild Endometriosis
Study Start Date : May 2007
Primary Completion Date : June 2010
Study Completion Date : June 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endometriosis
Drug Information available for: Letrozole
U.S. FDA Resources

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.



Primary Outcome Measures :
  1. Clinical pregnancy rate per cycle [ Time Frame: 6-7 weeks gestation ]

Secondary Outcome Measures :
  1. Miscarriage rate. [ Time Frame: Up to 20 weeks gestation ]


Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 36 Years   (Adult)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Publications:
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
First Posted: April 13, 2011    Key Record Dates
Last Update Posted: April 13, 2011
Last Verified: April 2011

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

Additional relevant MeSH terms:
Endometriosis
Genital Diseases, Female
Letrozole
Antineoplastic Agents
Aromatase Inhibitors
Steroid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs