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Sponsored by: |
University Magna Graecia |
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Information provided by: | University Magna Graecia |
ClinicalTrials.gov Identifier: | NCT00558077 |
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 |
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Polycystic Ovary Syndrome Infertility Anovulation |
Drug: Metformin plus clomiphene citrate Procedure: Laparoscopic ovarian drilling |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
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 |
Enrollment: | 50 |
Study Start Date: | February 2003 |
Estimated Study Completion Date: | October 2005 |
Arms | Assigned Interventions |
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A: Experimental
Metformin plus clomiphene citrate
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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.
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B: Active Comparator
Laparoscopic ovarian drilling
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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.
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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.
Ages Eligible for Study: | 18 Years to 35 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Italy, Catanzaro/Italy | |
"Pugliese" Hospital | |
Catanzaro, Catanzaro/Italy, Italy, 88100 |
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 |
Study ID Numbers: | 01/2003 |
Study First Received: | November 13, 2007 |
Last Updated: | November 13, 2007 |
ClinicalTrials.gov Identifier: | NCT00558077 History of Changes |
Health Authority: | Italy: The Italian Medicines Agency |
Anovulation Clomiphene citrate Fertility Metformin Ovulation induction |
PCOS Sterility Treatment Clomiphene citrate-resistance |
Infertility Estrogen Antagonists Estrogens Hyaluronic Acid Gonadal Disorders Hormone Antagonists Citric Acid Metformin Hormones, Hormone Substitutes, and Hormone Antagonists Endocrine System Diseases Clomiphene Ovarian Diseases |
Selective Estrogen Receptor Modulators Genital Diseases, Male Cysts Hormones Polycystic Ovarian Syndrome Genital Diseases, Female Estrogen Receptor Modulators Hypoglycemic Agents Polycystic Ovary Syndrome Endocrinopathy Anovulation Ovarian Cysts |
Infertility Gonadal Disorders Hormone Antagonists Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Clomiphene Reproductive Control Agents Ovarian Diseases Selective Estrogen Receptor Modulators Genital Diseases, Female Estrogen Receptor Modulators Hypoglycemic Agents Pathologic Processes Therapeutic Uses Syndrome |
Estrogen Antagonists Disease Metformin Endocrine System Diseases Cysts Genital Diseases, Male Pharmacologic Actions Adnexal Diseases Neoplasms Fertility Agents, Female Polycystic Ovary Syndrome Fertility Agents Anovulation Ovarian Cysts |