Official Title: “Comparison of Three Different Strategies for Treating Infertility in Anovulatory Women With Polycystic Ovary Syndrome: a Multicentre Randomized Controlled Clinical Trial”

Anovulatory infertility is a common feature of the polycystic ovary syndrome (PCOS). Even if several first-step treatments have been proposed for anovulatory infertile PCOS patients, very few data are available in literature regarding the best integrated strategy. In fact, a single compound could be effective as first-step approach but not or less useful when integrated in a more complex strategy.

The goal of the current protocol will be to compare three different strategies for treating anovulatory infertility in PCOS patients having as primary end-point the multiple pregnancy rate.

Study Type: Interventional

Study Design: Treatment, Randomized, Open Label, Active Control, Crossover Assignment, Efficacy Study

All patients eligible will undergo baseline assessment consisting of antropometric, hormonal, and ultrasonographic assessments. Successively, patients enrolled will be allocated in three different strategies (strategy A, B, and C).

A total of 184 infertile PCOS patients per arm will be enrolled and treated with three different integrated strategies: clomiphene followed by clomiphene plus metformin followed by gonadotropins (strategy A); metformin followed by metformin plus clomiphene followed by gonadotropins(strategy B); and metformin plus clomiphene followed by gonadotropins(strategy C).

In all patients, the same regimen will be used to administered clomiphene, metformin, and gonadotropins.Both clomiphene and metformin will be administered at incremental doses in each case.Gonadotropins will be administrated to obtain a controlled ovarian stimulation using highly purified urinary FSH in a low-dose step-up protocol.

During the study, the clinical and reproductive outcomes, and adverse experiences will be evaluated in each woman.

Intervention(s) in this Clinical Trial

• Drug: Clomiphene citrate, metformin, metformin plus clomiphene citrate, gonadotropins

Primary Measures

• Multiple pregnancy rate

Secondary Measures

• Ovulation rate
• Pregnancy rate
• Abortion rate
• Live-birth rate
• Adverse-events

Inclusion Criteria:

• Polycystic ovary syndrome (using ESHRE/ARSM 2004 criteria)

Exclusion Criteria:

• Age <18 or >35 years
• Severe obesity (BMI >35)
• Neoplastic, metabolic, hepatic, and cardiovascular disorders or other concurrent medical illnesses
• Hypothyroidism, hyperprolactinemia, Cushing’s syndrome, and non-classical congenital adrenal hyperplasia
• Current or previous (within the last six months) use of oral contraceptives, glucocorticoids, antiandrogens, antidiabetic and anti-obesity drugs or other hormonal drugs
• Previous use of ovulation induction agents
• Intention to start a diet or a specific program of physical activity
• No uterine bleeding after progesterone challenge test
• Organic pelvic diseases
• Previous pelvic surgery
• Suspected peritoneal factor infertility
• Tubal or male factor infertility or sub-fertility

Gender Eligibility for this Clinical Trial: Female

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 35 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers

Lead Sponsor: University Magna Graecia

Overall Clinical Trial Officials and Contacts

Stefano Palomba, MD Principal Investigator Department of Obstetrics and Gynecology, University "Magna Graecia" of Catanzaro  

Overall Contact: Stefano Palomba, MD +39-0961.883234 stefanopalomba@tin.it

Information obtained from ClinicalTrials.gov on October 07, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00461643

Study ID Number: 01/2007

ClinicalTrials.gov Identifier: NCT00461643

Health Authority: Italy: The Italian Medicines Agency