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

Primary Purpose

Endometriosis

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Letrozole/IUI
CC/IUI
Sponsored by
Mansoura University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Endometriosis focused on measuring minimal to mild endometriosis, letrozole, clomiphene citrate, IUI

Eligibility Criteria

20 Years - 36 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Mansoura University Hospitals,OB/GYN department

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Letrozole/IUI

CC/IUI

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Clinical pregnancy rate per cycle

Secondary Outcome Measures

Miscarriage rate.

Full Information

First Posted
April 11, 2011
Last Updated
April 12, 2011
Sponsor
Mansoura University
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1. Study Identification

Unique Protocol Identification Number
NCT01334762
Brief Title
Efficacy of Letrozole and CC Alone in an IUI Program in Cases With Surgically Treated Minimal to Mild Endometriosis
Official Title
Letrozole and CC Alone in an IUI Program in Women With Surgically Treated Minimal to Mild Endometriosis
Study Type
Interventional

2. Study Status

Record Verification Date
April 2011
Overall Recruitment Status
Completed
Study Start Date
May 2007 (undefined)
Primary Completion Date
June 2010 (Actual)
Study Completion Date
June 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Mansoura University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Endometriosis
Keywords
minimal to mild endometriosis, letrozole, clomiphene citrate, IUI

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
136 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Letrozole/IUI
Arm Type
Experimental
Arm Description
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.
Arm Title
CC/IUI
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Letrozole/IUI
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
CC/IUI
Intervention Description
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 Measure Information:
Title
Clinical pregnancy rate per cycle
Time Frame
6-7 weeks gestation
Secondary Outcome Measure Information:
Title
Miscarriage rate.
Time Frame
Up to 20 weeks gestation

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
36 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hatem Abu Hashim, MD MRCOG
Organizational Affiliation
Mansoura University Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Mohamed El Rakhawy, MD
Organizational Affiliation
Mansoura University Hospital
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Ibrahim Abd Elaal
Organizational Affiliation
Mansoura University Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Mansoura University Hospitals,OB/GYN department
City
Mansoura
State/Province
Dakahlia Governorate
ZIP/Postal Code
35511
Country
Egypt

12. IPD Sharing Statement

Citations:
PubMed Identifier
12372451
Citation
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. doi: 10.1016/s0015-0282(02)03343-5.
Results Reference
background
PubMed Identifier
16952506
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. doi: 10.1016/j.fertnstert.2006.01.044.
Results Reference
background
PubMed Identifier
22181973
Citation
Abu Hashim H, El Rakhawy M, Abd Elaal I. Randomized comparison of superovulation with letrozole vs. clomiphene citrate in an IUI program for women with recently surgically treated minimal to mild endometriosis. Acta Obstet Gynecol Scand. 2012 Mar;91(3):338-45. doi: 10.1111/j.1600-0412.2011.01346.x. Epub 2012 Jan 26. Erratum In: Acta Obstet Gynecol Scand. 2021 Jun 23;:
Results Reference
derived

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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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