Strategies for Ovulation Induction in Anovulatory Infertile Patients With PCOS

University Magna Graecia

Status and phase: Unknown; Phase 4

Conditions: Anovulatory Infertility Related to Polycystic Ovary Syndrome

Treatments: Drug: Clomiphene citrate, metformin, metformin plus clomiphene citrate, gonadotropins

Study type: Interventional

Funder types: Other

Identifiers

NCT00461643

01/2007

Details and patient eligibility

About

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.

Full description

All patients eligible will undergo baseline assessment consisting of antropometric, hormonal, and ultrasonographic assessments. Successively, patients enrolled will be allocated in three different strategies (strategy A, B, and C).

A total of 184 infertile PCOS patients per arm will be enrolled and treated with three different integrated strategies: clomiphene followed by clomiphene plus metformin followed by gonadotropins (strategy A); metformin followed by metformin plus clomiphene followed by gonadotropins(strategy B); and metformin plus clomiphene followed by gonadotropins(strategy C).

In all patients, the same regimen will be used to administered clomiphene, metformin, and gonadotropins.Both clomiphene and metformin will be administered at incremental doses in each case.Gonadotropins will be administrated to obtain a controlled ovarian stimulation using highly purified urinary FSH in a low-dose step-up protocol.

During the study, the clinical and reproductive outcomes, and adverse experiences will be evaluated in each woman.

Enrollment: 552 estimated patients

Sex: Female

Ages: 18 to 35 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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552 participants in 3 patient groups

Strategy A

Active Comparator group

Description:

clomiphene followed by clomiphene plus metformin followed by gonadotropins

Treatment:

Drug: Clomiphene citrate, metformin, metformin plus clomiphene citrate, gonadotropins

Strategy B

Active Comparator group

Description:

metformin followed by metformin plus clomiphene followed by gonadotropins

Treatment:

Drug: Clomiphene citrate, metformin, metformin plus clomiphene citrate, gonadotropins

Strategy C

Active Comparator group

Description:

metformin plus clomiphene followed by gonadotropins

Treatment:

Drug: Clomiphene citrate, metformin, metformin plus clomiphene citrate, gonadotropins