Second-Line Treatments for Anovulatory Infertility in PCOS Patients

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

Intervention: Metformin plus clomiphene citrate (Drug); Laparoscopic ovarian drilling (Procedure)

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 and Gynecology, University "Magna Graecia" of Catanzaro
Fulvio Zullo, MD, Study Chair, Affiliation: Department of Obstetrics and Gynecology, University "Magna Graecia" of Catanzaro

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.

Official title: Laparoscopic Ovarian Diathermy or Metformin Plus Clomiphene Citrate Administration as Second-Line Treatment for Infertile Anovulatory Patients With Polycystic Ovary Syndrome: a Randomized Controlled Trial

Study design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study

Primary outcome: Live-birth rate

Secondary outcome:

Spontaneous menses

Pregnancy rate

Abortion rate

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.

Minimum age: 18 Years. Maximum age: 35 Years. Gender(s): Female.

Criteria:

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

"Pugliese" Hospital, Catanzaro, Catanzaro/Italy 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, Nardo LG, Falbo A, Russo T, Corea D, Doldo P, Lombardi G, Tolino A, Colao A, Zullo F. Metformin administration versus laparoscopic ovarian diathermy in clomiphene citrate-resistant women with polycystic ovary syndrome: a prospective parallel randomized double-blind placebo-controlled trial. J Clin Endocrinol Metab. 2004 Oct;89(10):4801-9. Erratum in: J Clin Endocrinol Metab. 2005 Jul;90(7):3945.

Starting date: February 2003
Ending date: October 2005
Last updated: November 13, 2007