Second-Line Treatments for Anovulatory Infertility in PCOS Patients

NCT00558077 | Completed Phase 4 DMC

• 1 other identifier: 01/2003
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Polycystic Ovary Syndrome; Infertility; Anovulation

Keywords

Anovulation; Clomiphene citrate; Fertility; Metformin; Ovulation induction; PCOS; Sterility; Treatment; Clomiphene citrate-resistance

Outcome Measures

Primary Outcomes (1)

• Live-birth rate

  fifteen months

Secondary Outcomes (3)

• Spontaneous menses

  six months

• Pregnancy rate

  six months

• Abortion rate

  fifteen months

Study Arms (2)

A

EXPERIMENTAL

Metformin plus clomiphene citrate

Drug: Metformin plus clomiphene citrate

B

ACTIVE COMPARATOR

Laparoscopic ovarian drilling

Procedure: Laparoscopic ovarian drilling

Interventions

Metformin plus clomiphene citrate DRUG

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.

A

Laparoscopic ovarian drilling PROCEDURE

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.

B

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• PCOS
• Clomiphene citrate-resistance
• Anovulation
• Infertility

You may not qualify if:

• 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

Sponsors & Collaborators

• University Magna Graecia: lead

Study Sites (1)

"Pugliese" Hospital

Catanzaro, Catanzaro/Italy, 88100, Italy

Location

Related Publications (2)

• Palomba S, Orio F Jr, Falbo A, Manguso F, Russo T, Cascella T, Tolino A, Carmina E, Colao A, Zullo F. Prospective parallel randomized, double-blind, double-dummy controlled clinical trial comparing clomiphene citrate and metformin as the first-line treatment for ovulation induction in nonobese anovulatory women with polycystic ovary syndrome. J Clin Endocrinol Metab. 2005 Jul;90(7):4068-74. doi: 10.1210/jc.2005-0110. Epub 2005 Apr 19.

  PMID: 15840746 BACKGROUND

• Palomba S, Orio F Jr, Nardo LG, Falbo A, Russo T, Corea D, Doldo P, Lombardi G, Tolino A, Colao A, Zullo F. Metformin administration versus laparoscopic ovarian diathermy in clomiphene citrate-resistant women with polycystic ovary syndrome: a prospective parallel randomized double-blind placebo-controlled trial. J Clin Endocrinol Metab. 2004 Oct;89(10):4801-9. doi: 10.1210/jc.2004-0689.

  PMID: 15472166 BACKGROUND

MeSH Terms

Conditions

Polycystic Ovary Syndrome; Infertility; Anovulation

Interventions

Metformin; Clomiphene

Condition Hierarchy (Ancestors)

Ovarian Cysts; Cysts; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Gonadal Disorders; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals; Stilbenes; Benzylidene Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Study Officials

• Stefano Palomba, MD

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

  PRINCIPAL INVESTIGATOR

• Fulvio Zullo, MD

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

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 13, 2007
• First Posted: November 14, 2007
• Study Start: February 1, 2003
• Study Completion: October 1, 2005
• Last Updated: November 14, 2007

Record last verified: 2007-11

Locations

IT (1)