Strategies for Ovulation Induction in Anovulatory Infertile Patients With PCOS
- Conditions
- Anovulatory Infertility Related to Polycystic Ovary Syndrome
- Interventions
- Registration Number
- NCT00461643
- Lead Sponsor
- University Magna Graecia
- Brief 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.
- Detailed 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Female
- Target Recruitment
- 552
- Polycystic ovary syndrome (using ESHRE/ARSM 2004 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Strategy A Clomiphene citrate, metformin, metformin plus clomiphene citrate, gonadotropins clomiphene followed by clomiphene plus metformin followed by gonadotropins Strategy B Clomiphene citrate, metformin, metformin plus clomiphene citrate, gonadotropins metformin followed by metformin plus clomiphene followed by gonadotropins Strategy C Clomiphene citrate, metformin, metformin plus clomiphene citrate, gonadotropins metformin plus clomiphene followed by gonadotropins
- Primary Outcome Measures
Name Time Method Multiple pregnancy rate 9 months
- Secondary Outcome Measures
Name Time Method Ovulation rate 15 months Pregnancy rate 15 months Abortion rate 15 months Live-birth rate 24 months Adverse-events 15
Trial Locations
- Locations (2)
"Pugliese" Hospital
🇮🇹Catanzaro, Italy
Pugliese-Ciaccio Hospital
🇮🇹Catanzaro, Italy