Letrozole Versus Laparoscopic Ovarian Drilling in Polycystic Ovary Syndrome
1 other identifier
interventional
150
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Jan 2017
Longer than P75 for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 1, 2017
CompletedStudy Start
First participant enrolled
January 2, 2017
CompletedFirst Posted
Study publicly available on registry
January 4, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2023
CompletedMay 9, 2022
May 1, 2022
5.9 years
January 1, 2017
May 6, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
The ovulation rate
3 months
Secondary Outcomes (1)
The mid-cyclic endometrial thickness
one day
Study Arms (2)
letrozole
ACTIVE COMPARATORletrozole 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
laparoscopic drilling
ACTIVE COMPARATORlaparoscopy 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
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Assiut University
Asyut, Egypt
Related Publications (1)
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.
PMID: 36165742DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Dr.
Study Record Dates
First Submitted
January 1, 2017
First Posted
January 4, 2017
Study Start
January 2, 2017
Primary Completion
December 1, 2022
Study Completion
August 1, 2023
Last Updated
May 9, 2022
Record last verified: 2022-05
Data Sharing
- IPD Sharing
- Will share