Study to Compare Between Combimed Metformin-letrozole and Ovarian Drilling in Pcos With Bilateral Ovarian Drilling in Clomiphene-resistant Infertile Women With Polycystic Ovarian Syndrome

Zagazig University

Status and phase: Completed; Phase 1

Conditions: Focus of Study

Treatments: Drug: metformin plus letrozole; Procedure: ovarian drilling

Study type: Interventional

Funder types: Other

Identifiers

NCT01693289

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Details and patient eligibility

About

the study compare the hormonal-metabolic and reproductive outcome between combined metformin-letrozole and ovarian drilling in clomiphene resistant women with polycystic syndrome

Enrollment: 146 patients

Sex: Female

Ages: 18 to 35 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• polycystic ovary syndrome
• infertility
• clomiphene citrate resistance

Exclusion criteria

• women with other causes of infertility as male factor or tubal factor, those with endocrine disorders as thyroid dysfunction and hyperprolactinemia women who received hormonal treatment or ovulation induction drugs 3 months prior to the study
• pregnancy during follow up

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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146 participants in 2 patient groups

Metformin plus letrozole

Experimental group

Description:

metformin :850mg tablets twice daily for 6 months letrozole :5mg tablets twice daily form day 3to7 of cycle

Treatment:

Drug: metformin plus letrozole

ovarian drilling

Experimental group

Description:

bilateral diathermy ovarian drilling, four drills each ovary

Treatment:

Procedure: ovarian drilling