Letrozole Versus Laparoscopic Ovarian Drilling in Polycystic Ovary Syndrome

Infertility Clinical Trial

Official title:

Letrozole Versus Laparoscopic Ovarian Drilling for Clomiphene-resistant Women With Polycystic Ovary Syndrome

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03009838
• Other study ID #: LEVOD
• Status: Recruiting
• Phase: Phase 3
• Start date: January 2, 2017
• Est. completion date: August 2023

Study information

• Verified date: May 2022
• Source: Assiut University
• Contact: Ahmed Abbas, MD
• Phone: 00201003385183
• Email: bmr90[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: August 2023
• Est. primary completion date: December 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 35 Years

Eligibility

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.

Related Conditions & MeSH terms

• Infertility
• Polycystic Ovary Syndrome

Intervention

Drug:
• Letrozole
oral tablets 2.5 mg

Procedure:
• ovarian drilling
laparoscopic electrocauterization

Locations

Country	Name	City	State
Egypt	Assiut University	Assiut

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The ovulation rate		3 months
Secondary	The mid-cyclic endometrial thickness		one day