Strategies for Ovulation Induction in Anovulatory Infertile Patients With PCOS

• Status: Unknown status
• 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). Even if several first-step treatments have been proposed for anovulatory infertile PCOS patients, very few data are available in literature regarding the best integrated strategy. In fact, a single compound could be effective as first-step approach but not or less useful when integrated in a more complex strategy.

The goal of the current protocol will be to compare three different strategies for treating anovulatory infertility in PCOS patients having as primary end-point the multiple pregnancy rate.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

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

Criteria

Inclusion Criteria:

• Polycystic ovary syndrome (using ESHRE/ARSM 2004 criteria)

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

• Previous use of ovulation induction agents

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

• No uterine bleeding after progesterone challenge test

• Organic pelvic diseases

• Previous pelvic surgery

• Suspected peritoneal factor infertility

• Tubal or male factor infertility or sub-fertility