Letrozole Versus Laparoscopic Ovarian Drilling in Polycystic Ovary Syndrome

• Register: ClinicalTrials.gov
• Last refreshed on: 16 May 2022
• Main ID: NCT03009838
• Date of registration: 01/01/2017
• Prospective Registration: Yes
• Primary sponsor: Assiut University
• Public title: Letrozole Versus Laparoscopic Ovarian Drilling in Polycystic Ovary Syndrome
• Scientific title: Letrozole Versus Laparoscopic Ovarian Drilling for Clomiphene-resistant Women With Polycystic Ovary Syndrome
• Date of first enrolment: January 2, 2017
• Target sample size: 150
• Recruitment status: Recruiting
• URL: https://clinicaltrials.gov/show/NCT03009838
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 3

Countries of recruitment

Egypt

Contacts

• Name: Ahmed Abbas, MD

• Name: Ahmed Abbas, MD

Key inclusion & exclusion 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.



Age minimum: 20 Years
Age maximum: 35 Years
Gender: Female

Health Condition(s) or Problem(s) studied

Infertility

Intervention(s)

Drug: Letrozole

Procedure: ovarian drilling

Primary Outcome(s)

The ovulation rate [Time Frame: 3 months]

Secondary Outcome(s)

The mid-cyclic endometrial thickness [Time Frame: one day]

Secondary ID(s)

LEVOD

Source(s) of Monetary Support

Please refer to primary and secondary sponsors