Second-Line Treatments for Anovulatory Infertility in PCOS Patients

This study has been completed.
Sponsor:
Information provided by:
University Magna Graecia
ClinicalTrials.gov Identifier:
NCT00558077
First received: November 13, 2007
Last updated: NA
Last verified: November 2007
History: No changes posted

November 13, 2007
November 13, 2007
February 2003
Not Provided
Live-birth rate [ Time Frame: fifteen months ]
Same as current
No Changes Posted
  • Spontaneous menses [ Time Frame: six months ]
  • Pregnancy rate [ Time Frame: six months ]
  • Abortion rate [ Time Frame: fifteen months ]
Same as current
Not Provided
Not Provided
 
Second-Line Treatments for Anovulatory Infertility in PCOS Patients
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.

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Polycystic Ovary Syndrome
  • Infertility
  • Anovulation
  • 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.
  • Experimental: A
    Metformin plus clomiphene citrate
    Intervention: Drug: Metformin plus clomiphene citrate
  • Active Comparator: B
    Laparoscopic ovarian drilling
    Intervention: Procedure: Laparoscopic ovarian drilling

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
50
October 2005
Not Provided

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
Female
18 Years to 35 Years
No
Contact information is only displayed when the study is recruiting subjects
Italy
 
NCT00558077
01/2003
Yes
Not Provided
University Magna Graecia
Not Provided
Principal Investigator: Stefano Palomba, MD Department of Obstetrics and Gynecology, University "Magna Graecia" of Catanzaro
Study Chair: Fulvio Zullo, MD Department of Obstetrics and Gynecology, University "Magna Graecia" of Catanzaro
University Magna Graecia
November 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP