Letrozole Versus Laparoscopic Ovarian Drilling in Polycystic Ovary Syndrome

Assiut University

Status and phase: Unknown; Phase 3

Conditions: Infertility

Treatments: Procedure: ovarian drilling; Drug: Letrozole

Study type: Interventional

Funder types: Other

Identifiers

NCT03009838

LEVOD

Details and patient eligibility

About

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.

Enrollment: 150 estimated patients

Sex: Female

Ages: 20 to 35 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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150 participants in 2 patient groups

letrozole

Active Comparator group

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

Treatment:

Drug: Letrozole

laparoscopic drilling

Active Comparator group

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

Treatment:

Procedure: ovarian drilling