Clomiphene Citrate in Infertile PCOS Patients

• Status: Withdrawn
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: Female

Summary

Anovulatory infertility is a common feature of the polycystic ovary syndrome (PCOS). Clomiphene citrate (CC) represents the first therapeutic option for treating the anovulatory infertility in PCOS patients because it is characterized by low costs, limited dose-dependent side effects, and simplicity of administration and management due to no need for ongoing monitoring.

Excellent results in terms of ovulations have been obtained using CC. However, only 50% of patients who ovulates under CC will conceive. The exact explanation for the discrepancy between the ovulation and pregnancy rates is unknown, but several hypotheses on the anti-estrogenic effects that CC exerts on the ovary and uterus have been suggested.

To date, few data are available on the optimal schedule for CC administration, and it is unknown how long patients who ovulate under CC should continue treatment before switching to second-line ovulation induction therapy. The aim of the study was to define the clinical benefits of CC administration according to its duration of administration.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Magna Graecia
• Treatments: Citric Acid; Clomiphene; Enclomiphene; Zuclomiphene

Criteria

Inclusion Criteria:

• Polycystic ovary syndrome (using NIH criteria)

• Anovulatory infertility (using WHO criteria)

• Previous three CC-stimulated ovulatory cycles

Exclusion Criteria:

• Age <18 or >35 years

• Severe obesity (BMI >35)

• 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, antidiabetic and anti-obesity drugs or other hormonal drugs

• Intention to start a diet or a specific program of physical activity

• Organic pelvic diseases

• Previous pelvic surgery

• Suspected peritoneal factor infertility

• Tubal or male factor infertility or sub-fertility