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Comparison of Three Different Strategies for Treating Infertility in Anovulatory Women With Polycystic Ovary Syndrome: a Multicentre Randomized Controlled Clinical Trial


Phase 4
18 Years
35 Years
Open (Enrolling)
Female
Anovulatory Infertility Related to Polycystic Ovary Syndrome

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Trial Information

Comparison of Three Different Strategies for Treating Infertility in Anovulatory Women With Polycystic Ovary Syndrome: a Multicentre Randomized Controlled Clinical Trial


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.


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Multiple pregnancy rate

Outcome Time Frame:

9 months

Safety Issue:

Yes

Principal Investigator

Stefano Palomba, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Department of Obstetrics and Gynecology, University "Magna Graecia" of Catanzaro

Authority:

Italy: The Italian Medicines Agency

Study ID:

01/2007

NCT ID:

NCT00461643

Start Date:

January 2007

Completion Date:

Related Keywords:

  • Anovulatory Infertility Related to Polycystic Ovary Syndrome
  • Anovulation
  • Clomiphene citrate
  • Infertility
  • Metformin
  • PCOS
  • RCT
  • Treatment
  • Infertility
  • Polycystic Ovary Syndrome

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