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OpenTrials
Completed

NCT Number: NCT00471523

Treatment of Anovulatory Infertility in PCOS Patients

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.

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Key information

Conditions

Infertility Adnexal Diseases Anovulation Cysts Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Gonadal Disorders Neoplasms Ovarian Cysts Ovarian Diseases Polycystic Ovary Syndrome Urogenital Diseases

Age range

18 year–41 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

"Pugliese Hospital"

Catanzaro, CZ, 88100, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Clomiphene Citrate

Drug

metformin

Drug

Primary outcomes

  1. Pregnancy rate

    Time frame: 10 months

Secondary outcomes

  1. Ovulation rate

    Time frame: 6 months

  2. Abortion rate

    Time frame: 10 months

  3. Time to first pregnancy

    Time frame: 10 months

  4. Adverse events

    Time frame: 10 months

  5. N. pregnancies/n. ovulatory cycles

    Time frame: 10 months

Sponsors and collaborators

Lead sponsor

University Magna Graecia

Other

Registry information

Official study title

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

Important dates

Study start
2006
Study completion
2007
First posted
May 10, 2007
Registry last updated
May 10, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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