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Treatment of Anovulatory Infertility in PCOS Patients

NCT ID: NCT00471523

Last Updated: 2007-05-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-05-31

Study Completion Date

2007-03-31

Brief Summary

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Clomiphene citrate (CC) and metformin are two effective drugs used to induce ovulation in patients with polycystic ovary syndrome (PCOS), even if it is still unclear which compound between them should be initially administered. The aim of the study will be to compare in a clinical setting the efficacy of CC and metformin as first-line approaches for treating anovulation in infertile PCOS patients.

Detailed Description

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Eighty infertile anovulatory patients with PCOS will be allocated in two body mass index (BMI)- and age-matched groups (experimental and control groups).

Forty patients will receive the experimental treatment consisting of six months of 1700 mg/day metformin administration (experimental group), whereas other forty patients will receive CC administered using a traditional incremental-doses protocol (control group). In both groups, patients who will ovulate under treatment will continue the therapy for a total of six months.

During the study, the clinical and reproductive outcomes, and the adverse experience will be evaluated in each patient.

Conditions

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Infertility Polycystic Ovary Syndrome Anovulation

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Clomiphene citrate

Intervention Type DRUG

Metformin

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Anovulatory infertility related to polycystic ovary syndrome

Exclusion Criteria

* Neoplastic, metabolic, hepatic, and cardiovascular disorders or other concurrent medical illnesses
* Hypothyroidism, hyperprolactinemia, Cushing's syndrome, and non-classical congenital adrenal hyperplasia
* Current or previous (within the last six months) use of oral contraceptives, glucocorticoids, antiandrogens, ovulation induction agents, antidiabetic and anti-obesity drugs or other hormonal drugs.
* Organic pelvic diseases
* Previous pelvic surgery
* Suspected peritoneal factor infertility
* Tubal or male factor infertility or sub-fertility
Minimum Eligible Age

18 Years

Maximum Eligible Age

41 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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University Magna Graecia

OTHER

Sponsor Role lead

Principal Investigators

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Stefano Palomba, MD

Role: PRINCIPAL_INVESTIGATOR

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

Achille Tolino, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Obstetrics & Gynecology, University "Federico II" of Naples

Francesco Orio, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Endocrinology, University "Federico II" of Naples

Locations

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"Pugliese Hospital"

Catanzaro, CZ, Italy

Site Status

Countries

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Italy

References

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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.

Reference Type BACKGROUND
PMID: 15840746 (View on PubMed)

Palomba S, Orio F Jr, Falbo A, Russo T, Tolino A, Zullo F. Effects of metformin and clomiphene citrate on ovarian vascularity in patients with polycystic ovary syndrome. Fertil Steril. 2006 Dec;86(6):1694-701. doi: 10.1016/j.fertnstert.2006.05.035. Epub 2006 Oct 30.

Reference Type BACKGROUND
PMID: 17074337 (View on PubMed)

Palomba S, Orio F, Zullo F. Ovulation induction in women with polycystic ovary syndrome. Fertil Steril. 2006 Jul;86 Suppl 1:S26-7. doi: 10.1016/j.fertnstert.2006.03.018.

Reference Type BACKGROUND
PMID: 16798282 (View on PubMed)

Palomba S, Russo T, Orio F Jr, Falbo A, Manguso F, Sammartino A, Tolino A, Colao A, Carmina E, Zullo F. Uterine effects of clomiphene citrate in women with polycystic ovary syndrome: a prospective controlled study. Hum Reprod. 2006 Nov;21(11):2823-9. doi: 10.1093/humrep/del267. Epub 2006 Jul 10.

Reference Type BACKGROUND
PMID: 16835214 (View on PubMed)

Palomba S, Falbo A, Orio F Jr, Tolino A, Zullo F. Efficacy predictors for metformin and clomiphene citrate treatment in anovulatory infertile patients with polycystic ovary syndrome. Fertil Steril. 2009 Jun;91(6):2557-67. doi: 10.1016/j.fertnstert.2008.03.011. Epub 2008 Apr 28.

Reference Type DERIVED
PMID: 18440534 (View on PubMed)

Other Identifiers

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02-2006

Identifier Type: -

Identifier Source: org_study_id