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OpenTrials
Completed

NCT Number: NCT01334762

Efficacy of Letrozole and CC Alone in an IUI Program in Cases 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.

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Key information

Conditions

Endometriosis Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Urogenital Diseases

Age range

20 year–36 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Mansoura University Hospitals,OB/GYN department

Al Mansurah, Dakahlia Governorate, 35511, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Letrozole/IUI

Drug

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

Drug

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 outcomes

  1. Clinical pregnancy rate per cycle

    Time frame: 6-7 weeks gestation

Secondary outcomes

  1. Miscarriage rate.

    Time frame: Up to 20 weeks gestation

Sponsors and collaborators

Lead sponsor

Mansoura University

Other

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2010
Study completion
2010
First posted
Apr 13, 2011
Registry last updated
Apr 13, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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