Second-Line Treatments for Anovulatory Infertility in PCOS Patients

Phase 4

Completed

• Conditions: Polycystic Ovary Syndrome; Infertility; Anovulation
• Interventions: Drug: Metformin plus clomiphene citrate; Procedure: Laparoscopic ovarian drilling

• Registration Number: NCT00558077
• Lead Sponsor: University Magna Graecia

Brief 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.

Detailed Description

A total of 50 primary infertile anovulatory PCOS patients with documented CC-resistance will be enrolled and randomized into two groups of treatment of 25 subjects each. Group A will undergo diagnostic laparoscopy followed by metformin plus CC, whereas group B will undergo LOD followed by observation. Anovulatory patients will receive IM progesterone. The treatment will be of six months followed by nine-month of observation for pregnant patients. The incidence of spontaneous menses, and the pregnancy, abortion, and live-birth rates will be recorded.

Study Timeline

• Study Start: 2003-02
• Study Completion: 2005-10
• Status Verified: 2007-11
• Study First Submitted: 2007-11-13
• Study First Submitted QC: 2007-11-13
• Last Update Submitted: 2007-11-13
• Study First Posted: 2007-11-14
• Last Update Posted: 2007-11-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A	Metformin plus clomiphene citrate	Metformin plus clomiphene citrate
B	Laparoscopic ovarian drilling	Laparoscopic ovarian drilling

Primary Outcome Measures

Name	Time	Method
Live-birth rate	fifteen months

Secondary Outcome Measures

Name	Time	Method
Pregnancy rate	six months
Abortion rate	fifteen months
Spontaneous menses	six months

Trial Locations

Locations (1)

"Pugliese" Hospital; 🇮🇹 Catanzaro, Catanzaro/Italy, Italy