Second-Line Treatments for Anovulatory Infertility in PCOS Patients

University Magna Graecia

Status and phase: Completed; Phase 4

Conditions: Infertility; Polycystic Ovary Syndrome; Anovulation

Treatments: Drug: Metformin plus clomiphene citrate; Procedure: Laparoscopic ovarian drilling

Study type: Interventional

Funder types: Other

Identifiers

NCT00558077

01/2003

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 patients

Sex: Female

Ages: 18 to 35 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

A

Experimental group

Description:

Metformin plus clomiphene citrate

Treatment:

Drug: Metformin plus clomiphene citrate

B

Active Comparator group

Description:

Laparoscopic ovarian drilling

Treatment:

Procedure: Laparoscopic ovarian drilling