Symptoms and General Pathology

All Conditions

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Neoplasms

Gland and Hormone Related Diseases

Syndrome

Infertility

Polycystic Ovary Syndrome

Anovulation

Genital Diseases

Urogenital Diseases

Cysts

Ovarian Cysts

Ovarian Diseases

Adnexal Diseases

Genital Diseases, Female

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Gonadal Disorders

Endocrine System Diseases

Hypoglycemic Agents

All Drugs and Chemicals

Anticoagulants

Reproductive Control Agents

Bone Density Conservation Agents

Other Dietary Supplements

Metformin

Citric Acid

Sodium Citrate

Clomiphene

Enclomiphene

Zuclomiphene

Calcium

Calcium, Dietary

Chelating Agents

Estrogens

Estrogen Antagonists

Estrogen Receptor Antagonists

Hormones

Hormone Antagonists

Selective Estrogen Receptor Modulators

Estrogen Receptor Modulators

Citrate

clomiphene followed by clomiphene plus metformin followed by gonadotropins

metformin followed by metformin plus clomiphene followed by gonadotropins

metformin plus clomiphene followed by gonadotropins

Clomiphene citrate, metformin, metformin plus clomiphene citrate, gonadotropins

Stefano Palomba, MD

Ingrid Tomaino, MD

Francesco Orio, MD

Achille Tolino, MD

Pasquale Mastrantonio, MD

Brian Dale, MD

Ettore Cittadini, MD

Andrea Riccardo Genazzani, MD

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.

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.

Strategies for Ovulation Induction in Anovulatory Infertile Patients With PCOS

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

University Magna Graecia

Associate Professor

Spots Global Cancer Trial Database for clomiphene citrate, metformin, metformin plus clomiphene citrate, gonadotropins