Treatment of Anovulatory Infertility in PCOS Patients

Condition(s) targeted: Infertility; Polycystic Ovary Syndrome; Anovulation

Intervention: Clomiphene citrate (Drug); Metformin (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: University Magna Gaecia

Official(s) and/or principal investigator(s):
Stefano Palomba, MD, Principal Investigator, Affiliation: Department of Obstetrics & Gynecology, University “Magna Graecia” of Catanzaro
Achille Tolino, MD, Principal Investigator, Affiliation: Department of Obstetrics & Gynecology, University “Federico II” of Naples
Francesco Orio, MD, Principal Investigator, Affiliation: Department of Endocrinology, University “Federico II” of Naples

Clomiphene citrate (CC) and metformin are two effective drugs used to induce ovulation in patients with polycystic ovary syndrome (PCOS), even if it is still unclear which compound between them should be initially administered. The aim of the study will be to compare in a clinical setting the efficacy of CC and metformin as first-line approaches for treating anovulation in infertile PCOS patients.

Official title: Clomiphene Citrate Versus Metformin as First-Line Approach for the Treatment of Anovulation in Infertile Patients With Polycystic Ovary Syndrome

Study design: Treatment, Non-Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome: Pregnancy rate

Secondary outcome:

Ovulation rate

Abortion rate

Time to first pregnancy

Adverse events

N. pregnancies/n. ovulatory cycles

Detailed description: Eighty infertile anovulatory patients with PCOS will be allocated in two body mass index (BMI)- and age-matched groups (experimental and control groups).

Forty patients will receive the experimental treatment consisting of six months of 1700 mg/day metformin administration (experimental group), whereas other forty patients will receive CC administered using a traditional incremental-doses protocol (control group). In both groups, patients who will ovulate under treatment will continue the therapy for a total of six months.

During the study, the clinical and reproductive outcomes, and the adverse experience will be evaluated in each patient.

Minimum age: 18 Years. Maximum age: 41 Years. Gender(s): Female.

Criteria:

Inclusion Criteria:

- Anovulatory infertility related to polycystic ovary syndrome

Exclusion Criteria:

- 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, ovulation induction agents, antidiabetic and anti-obesity drugs or other hormonal drugs.

- Organic pelvic diseases

- Previous pelvic surgery

- Suspected peritoneal factor infertility

- Tubal or male factor infertility or sub-fertility

"Pugliese Hospital", Catanzaro, CZ 88100, Italy

Related publications:

Palomba S, Orio F Jr, Falbo A, Manguso F, Russo T, Cascella T, Tolino A, Carmina E, Colao A, Zullo F. Prospective parallel randomized, double-blind, double-dummy controlled clinical trial comparing clomiphene citrate and metformin as the first-line treatment for ovulation induction in nonobese anovulatory women with polycystic ovary syndrome. J Clin Endocrinol Metab. 2005 Jul;90(7):4068-74. Epub 2005 Apr 19.

Palomba S, Orio F Jr, Falbo A, Russo T, Tolino A, Zullo F. Effects of metformin and clomiphene citrate on ovarian vascularity in patients with polycystic ovary syndrome. Fertil Steril. 2006 Dec;86(6):1694-701. Epub 2006 Oct 30.

Palomba S, Orio F, Zullo F. Ovulation induction in women with polycystic ovary syndrome. Fertil Steril. 2006 Jul;86 Suppl 1:S26-7.

Palomba S, Russo T, Orio F Jr, Falbo A, Manguso F, Sammartino A, Tolino A, Colao A, Carmina E, Zullo F. Uterine effects of clomiphene citrate in women with polycystic ovary syndrome: a prospective controlled study. Hum Reprod. 2006 Nov;21(11):2823-9. Epub 2006 Jul 10.

Starting date: May 2006
Ending date: March 2007
Last updated: May 8, 2007