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Letrozole Versus Laparoscopic Ovarian Drilling in Polycystic Ovary Syndrome

Primary Purpose

Infertility

Status
Recruiting
Phase
Phase 3
Locations
Egypt
Study Type
Interventional
Intervention
Letrozole
ovarian drilling
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Infertility

Eligibility Criteria

20 Years - 35 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • History of at least one year of infertility either primary or secondary.
  • Body mass index: 25-35
  • Normal fallopian tubes
  • Normal semen analysis of the husband
  • Women who will accept to participate in the study

Exclusion Criteria:

  • Body mass index above 35
  • Contraindication to general anesthesia
  • Previous laparoscopic drilling
  • Presence of other causes of infertility
  • Women who had received metformin, gonadotrophin, oral contraceptives or other hormonal drugs during the preceding 6 months
  • Women who intended to start a diet program
  • Women who will refuse to participate in the study.

Sites / Locations

  • Assiut UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

letrozole

laparoscopic drilling

Arm Description

letrozole 2.5 mg oral tablets will be started daily from day 3 of the menses for 5 days in a dose of 5 mg/day

laparoscopy will be performed using three-puncture technique. Each ovary will be cauterized at four points, each for 4 seconds at 40 W for a depth of 4 mm with a mixed current, using a monopolar electrosurgical needle

Outcomes

Primary Outcome Measures

The ovulation rate

Secondary Outcome Measures

The mid-cyclic endometrial thickness

Full Information

First Posted
January 1, 2017
Last Updated
May 6, 2022
Sponsor
Assiut University
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1. Study Identification

Unique Protocol Identification Number
NCT03009838
Brief Title
Letrozole Versus Laparoscopic Ovarian Drilling in Polycystic Ovary Syndrome
Official Title
Letrozole Versus Laparoscopic Ovarian Drilling for Clomiphene-resistant Women With Polycystic Ovary Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Recruiting
Study Start Date
January 2, 2017 (Actual)
Primary Completion Date
December 2022 (Anticipated)
Study Completion Date
August 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Polycystic ovary syndrome is the major cause of anovulatory infertility. Clomiphene citrate is the most commonly used oral agent for ovulation induction in this group, but there are some drawbacks with the use of it.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
letrozole
Arm Type
Active Comparator
Arm Description
letrozole 2.5 mg oral tablets will be started daily from day 3 of the menses for 5 days in a dose of 5 mg/day
Arm Title
laparoscopic drilling
Arm Type
Active Comparator
Arm Description
laparoscopy will be performed using three-puncture technique. Each ovary will be cauterized at four points, each for 4 seconds at 40 W for a depth of 4 mm with a mixed current, using a monopolar electrosurgical needle
Intervention Type
Drug
Intervention Name(s)
Letrozole
Other Intervention Name(s)
femara
Intervention Description
oral tablets 2.5 mg
Intervention Type
Procedure
Intervention Name(s)
ovarian drilling
Intervention Description
laparoscopic electrocauterization
Primary Outcome Measure Information:
Title
The ovulation rate
Time Frame
3 months
Secondary Outcome Measure Information:
Title
The mid-cyclic endometrial thickness
Time Frame
one day

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: History of at least one year of infertility either primary or secondary. Body mass index: 25-35 Normal fallopian tubes Normal semen analysis of the husband Women who will accept to participate in the study Exclusion Criteria: Body mass index above 35 Contraindication to general anesthesia Previous laparoscopic drilling Presence of other causes of infertility Women who had received metformin, gonadotrophin, oral contraceptives or other hormonal drugs during the preceding 6 months Women who intended to start a diet program Women who will refuse to participate in the study.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ahmed Abbas, MD
Phone
00201003385183
Email
bmr90@hotmail.com
Facility Information:
Facility Name
Assiut University
City
Assiut
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ahmed Abbas, MD
Phone
00201003385183

12. IPD Sharing Statement

Plan to Share IPD
Yes
Citations:
PubMed Identifier
36165742
Citation
Franik S, Le QK, Kremer JA, Kiesel L, Farquhar C. Aromatase inhibitors (letrozole) for ovulation induction in infertile women with polycystic ovary syndrome. Cochrane Database Syst Rev. 2022 Sep 27;9(9):CD010287. doi: 10.1002/14651858.CD010287.pub4.
Results Reference
derived

Learn more about this trial

Letrozole Versus Laparoscopic Ovarian Drilling in Polycystic Ovary Syndrome

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