Second-Line Treatments for Anovulatory Infertility in PCOS Patients
Information source: University Magna Graecia
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Polycystic Ovary Syndrome; Infertility; Anovulation
Intervention: Metformin plus clomiphene citrate (Drug); Laparoscopic ovarian drilling (Procedure)
Phase: Phase 4
Status: Completed
Sponsored by: University Magna Graecia Official(s) and/or principal investigator(s): Stefano Palomba, MD, Principal Investigator, Affiliation: Department of Obstetrics and Gynecology, University "Magna Graecia" of Catanzaro Fulvio Zullo, MD, Study Chair, Affiliation: Department of Obstetrics and Gynecology, University "Magna Graecia" of Catanzaro
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.
Clinical Details
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 design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Live-birth rate
Secondary outcome: Spontaneous mensesPregnancy rate Abortion rate
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
Minimum age: 18 Years.
Maximum age: 35 Years.
Gender(s): Female.
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
Locations and Contacts
"Pugliese" Hospital, Catanzaro, Catanzaro/Italy 88100, Italy
Additional Information
Related publications: 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. Epub 2005 Apr 19. 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. Erratum in: J Clin Endocrinol Metab. 2005 Jul;90(7):3945.
Starting date: February 2003
Last updated: November 13, 2007
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