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

Endometriosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01334762
• Other study ID #: MU-157x
• Secondary ID: FMH-92-B
• Status: Completed
• Phase: N/A
• First received: April 11, 2011
• Last updated: April 12, 2011
• Start date: May 2007
• Est. completion date: June 2010

Study information

• Verified date: April 2011
• Source: Mansoura University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Egypt: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 136
• Est. completion date: June 2010
• Est. primary completion date: June 2010
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 36 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Endometriosis

Intervention

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.
• 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.

Locations

Country	Name	City	State
Egypt	Mansoura University Hospitals,OB/GYN department	Mansoura	Dakahlia Governorate

Sponsors (1)

Lead Sponsor	Collaborator
Mansoura University

Country where clinical trial is conducted

Egypt, 

References & Publications (2)

Dmowski WP, Pry M, Ding J, Rana N. Cycle-specific and cumulative fecundity in patients with endometriosis who are undergoing controlled ovarian hyperstimulation-intrauterine insemination or in vitro fertilization-embryo transfer. Fertil Steril. 2002 Oct;78(4):750-6. — View Citation

Werbrouck E, Spiessens C, Meuleman C, D'Hooghe T. No difference in cycle pregnancy rate and in cumulative live-birth rate between women with surgically treated minimal to mild endometriosis and women with unexplained infertility after controlled ovarian hyperstimulation and intrauterine insemination. Fertil Steril. 2006 Sep;86(3):566-71. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical pregnancy rate per cycle		6-7 weeks gestation	No
Secondary	Miscarriage rate.		Up to 20 weeks gestation	No