Overview

Second-Line Treatments for Anovulatory Infertility in PCOS Patients

Status:
Completed
Trial end date:
2005-10-01
Target enrollment:
0
Participant gender:
Female
Summary
To date, it is still unclear the potential role of laparoscopic ovarian diathermy (LOD) in the management of polycystic ovary syndrome (PCOS)-related anovulatory infertility. Metformin administration, alone or combined with clomiphene citrate (CC), has shown to be an effective and attractive second-line treatment for ovulation induction in women with polycystic ovary syndrome (PCOS) after failure of CC treatment. The aim of the present study will be to compare in a randomized controlled fashion the efficacy of LOD with metformin plus CC administration in the treatment of the CC-resistant PCOS patients.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
University Magna Graecia
Treatments:
Citric Acid
Clomiphene
Enclomiphene
Metformin
Zuclomiphene
Criteria
Inclusion Criteria:

- PCOS

- Clomiphene citrate-resistance

- Anovulation

- Infertility

Exclusion Criteria:

- Age < 18 or > 35 years

- Body mass index >35

- Neoplastic, metabolic, endocrine, hepatic, renal, and cardiovascular disorders or
other concurrent medical illnesses

- Current or previous use of oral contraceptives, glucocorticoids, antiandrogens,
ovulation induction agents, antidiabetic and anti-obesity drugs or other drugs
affecting hormone levels, carbohydrate metabolism, or appetite

- Pelvic diseases

- Previous pelvic surgery

- Suspected peritoneal factor infertility/subfertility

- Tubal or male factor infertility or sub-fertility