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
  Purpose

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 Intervention Phase
Polycystic Ovary Syndrome
Infertility
Anovulation
Drug: Metformin plus clomiphene citrate
Procedure: Laparoscopic ovarian drilling
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by University Magna Graecia:

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

Secondary Outcome Measures:
  • Spontaneous menses [ Time Frame: six months ]
  • Pregnancy rate [ Time Frame: six months ]
  • Abortion rate [ Time Frame: fifteen months ]

Enrollment: 50
Study Start Date: February 2003
Estimated Study Completion Date: October 2005
Arms Assigned Interventions
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.

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

Ages Eligible for Study:   18 Years to 35 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00558077

Locations
Italy
"Pugliese" Hospital
Catanzaro, Catanzaro/Italy, Italy, 88100
Sponsors and Collaborators
University Magna Graecia
Investigators
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
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00558077     History of Changes
Other Study ID Numbers: 01/2003
Study First Received: November 13, 2007
Last Updated: November 13, 2007
Health Authority: Italy: The Italian Medicines Agency

Keywords provided by University Magna Graecia:
Anovulation
Clomiphene citrate
Fertility
Metformin
Ovulation induction
PCOS
Sterility
Treatment
Clomiphene citrate-resistance

Additional relevant MeSH terms:
Anovulation
Infertility
Polycystic Ovary Syndrome
Syndrome
Adnexal Diseases
Cysts
Disease
Endocrine System Diseases
Genital Diseases, Female
Genital Diseases, Male
Gonadal Disorders
Neoplasms
Ovarian Cysts
Ovarian Diseases
Pathologic Processes
Citric Acid
Clomiphene
Enclomiphene
Metformin
Zuclomiphene
Anticoagulants
Chelating Agents
Estrogen Antagonists
Estrogen Receptor Modulators
Fertility Agents
Fertility Agents, Female
Hematologic Agents
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Hypoglycemic Agents

ClinicalTrials.gov processed this record on October 21, 2014