Letrozole or Laparoscopic Ovarian Diathermy for Women With CC Resistant Polycystic Ovary Syndrome.

Mansoura University

Status: Completed

Conditions: Polycystic Ovary Syndrome

Treatments: Procedure: Laparoscopic ovarian diathermy (LOD); Drug: Letrozole

Study type: Interventional

Funder types: Other

Identifiers

NCT00956267

FMH-052-K

MU- 094

Details and patient eligibility

About

The purpose of this study is to compare and determine the efficacy of letrozole administration to that of laparoscopic ovarian diathermy (LOD) in infertile women with Polycystic ovary syndrome(PCOS)not responding to treatment with Clomiphene alone.

Full description

In the letrozole group, withdrawal bleeding was achieved using 10 mg of dydrogesterone tablets for 10 days before stimulation, then 2.5 mg of letrozole oral tablets (Femara; Novartis Pharma Services, Switzerland) daily from day 3 of the menses for 5 days up to six cycles. All patients in the control group underwent laparoscopic ovarian diathermy, then followed up for 6 months.

Enrollment: 260 patients

Sex: Female

Ages: 20 to 36 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• CC resistant PCOS

Exclusion criteria

• Congenital adrenal hyperplasia
• Cushing syndrome
• Androgen secreting tumors

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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260 participants in 2 patient groups

Letrozole

Experimental group

Description:

2.5 mg letrozole oral tablets daily from day 3 of the menses for 5 days up to 6 cycles

Treatment:

Drug: Letrozole

Laparoscopic ovarian diathermy (LOD)

Active Comparator group

Description:

Three-puncture technique. Each ovary was cauterized at four points, each for 4 seconds at 40 W for a depth of 4 mm with a mixed current, using an monopolar electrosurgical needle.

Treatment:

Procedure: Laparoscopic ovarian diathermy (LOD)