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Treatment of Anovulatory Infertility in PCOS Patients

Clomiphene Citrate Versus Metformin as First-Line Approach for the Treatment of Anovulation in Infertile Patients With Polycystic Ovary Syndrome

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00471523
Enrollment
80
Registered
2007-05-10
Start date
2006-05-31
Completion date
2007-03-31
Last updated
2007-05-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anovulation, Infertility, Polycystic Ovary Syndrome

Keywords

Anovulation, Clomiphene citrate, Infertility, Metformin, PCOS, Treatment

Brief summary

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

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.

Interventions

DRUGClomiphene citrate
DRUGMetformin

Sponsors

University Magna Graecia
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 41 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Pregnancy rate10 months

Secondary

MeasureTime frame
Ovulation rate6 months
Abortion rate10 months
Time to first pregnancy10 months
Adverse events10 months
N. pregnancies/n. ovulatory cycles10 months

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026