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”

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.

Study Type: Interventional

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

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.

Intervention(s) in this Clinical Trial

• Drug: Metformin plus clomiphene citrate
  • Metformin administration will start from 3rd day of a P-induced withdrawal bleeding with a dose of 850 mg (1 tablet daily) and increasing the dosage after one week up to 1700 mg/day (two tablets daily). Clomiphene citrate CC will be administered for five days beginning on cycle day 3rd of a P-induced withdrawal bleeding using a starting dose of 50 mg daily. If ovulation will not occur, the dose will be increased by 50 mg in successive cycles until the ovulation will be achieved or up to a maximal dose of 150 mg daily.
• Procedure: Laparoscopic ovarian drilling
  • Laparoscopic ovarian drilling will be performed as follows: according to ovary size three to six punctures will be performed at each ovary inserting an insulated needle cautery of 36 mm perpendicularly as possible to the ovarian surface with a cutting current of 100 watt power. Then, the needle will be activated for 2-3 seconds at each point using a coagulating current of 40 watt power. At completion of the procedure, the ovarian surface will be washed with a crystalloid solution and all injured areas will be completely covered with hyaluronic acid gel.

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: A
  • Metformin plus clomiphene citrate
• Active Comparator: B
  • Laparoscopic ovarian drilling

Primary Measures

• Live-birth rate
  • Time Frame: fifteen months
    

Secondary Measures

• Spontaneous menses
  • Time Frame: six months
    
• Pregnancy rate
  • Time Frame: six months
    
• Abortion rate
  • Time Frame: fifteen months
    

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

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?: No

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  

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00558077

Study ID Number: 01/2003

ClinicalTrials.gov Identifier: NCT00558077

Health Authority: Italy: The Italian Medicines Agency