Second-Line Treatments for Anovulatory Infertility in PCOS Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00558077
Recruitment Status : Completed
First Posted : November 14, 2007
Last Update Posted : November 14, 2007
Information provided by:
University Magna Graecia

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.

Condition or disease Intervention/treatment Phase
Polycystic Ovary Syndrome Infertility Anovulation Drug: Metformin plus clomiphene citrate Procedure: Laparoscopic ovarian drilling Phase 4

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : February 2003
Study Completion Date : October 2005

Arm Intervention/treatment
Experimental: A
Metformin plus clomiphene citrate
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.

Active Comparator: B
Laparoscopic ovarian drilling
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.

Primary Outcome Measures :
  1. Live-birth rate [ Time Frame: fifteen months ]

Secondary Outcome Measures :
  1. Spontaneous menses [ Time Frame: six months ]
  2. Pregnancy rate [ Time Frame: six months ]
  3. Abortion rate [ Time Frame: fifteen months ]

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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00558077

"Pugliese" Hospital
Catanzaro, Catanzaro/Italy, Italy, 88100
Sponsors and Collaborators
University Magna Graecia
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

Publications: Identifier: NCT00558077     History of Changes
Other Study ID Numbers: 01/2003
First Posted: November 14, 2007    Key Record Dates
Last Update Posted: November 14, 2007
Last Verified: November 2007

Keywords provided by University Magna Graecia:
Clomiphene citrate
Ovulation induction
Clomiphene citrate-resistance

Additional relevant MeSH terms:
Polycystic Ovary Syndrome
Pathologic Processes
Genital Diseases, Male
Genital Diseases, Female
Ovarian Cysts
Ovarian Diseases
Adnexal Diseases
Gonadal Disorders
Endocrine System Diseases
Citric Acid
Hypoglycemic Agents
Physiological Effects of Drugs
Calcium Chelating Agents
Chelating Agents
Sequestering Agents
Molecular Mechanisms of Pharmacological Action
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists