Second-Line Treatments for Anovulatory Infertility in PCOS Patients
This study has been completed.
Sponsor:
University Magna Graecia
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
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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:
Drug Information available for:
Clomiphene citrate
Metformin
Clomiphene
Sodium citrate
Metformin hydrochloride
U.S. FDA Resources
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
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 Ovarian Diseases Adnexal Diseases Genital Diseases, Female Gonadal Disorders Endocrine System Diseases Genital Diseases, Male Ovarian Cysts Cysts Neoplasms Citric Acid Clomiphene Metformin |
Anticoagulants Hematologic Agents Therapeutic Uses Pharmacologic Actions Chelating Agents Molecular Mechanisms of Pharmacological Action Estrogen Antagonists Estrogen Receptor Modulators Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Fertility Agents, Female Fertility Agents Reproductive Control Agents Selective Estrogen Receptor Modulators |
ClinicalTrials.gov processed this record on May 19, 2013