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Spots Global Cancer Trial Database for Second-Line Treatments for Anovulatory Infertility in PCOS Patients

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Trial Identification

Brief Title: Second-Line Treatments for Anovulatory Infertility in 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 ID: NCT00558077

Study Description

Brief Summary: 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.

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.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT

Sex: FEMALE

Healthy Volunteers: No

Locations

"Pugliese" Hospital, Catanzaro, Catanzaro/Italy, Italy

Contact Details

Name: Stefano Palomba, MD

Affiliation: Department of Obstetrics and Gynecology, University "Magna Graecia" of Catanzaro

Role: PRINCIPAL_INVESTIGATOR

Name: Fulvio Zullo, MD

Affiliation: Department of Obstetrics and Gynecology, University "Magna Graecia" of Catanzaro

Role: STUDY_CHAIR

Useful links and downloads for this trial

Clinicaltrials.gov

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