Strategies for Ovulation Induction in Anovulatory Infertile Patients With PCOS

This study is currently recruiting participants.
Verified April 2013 by University Magna Graecia
Sponsor:
Information provided by (Responsible Party):
Stefano Palomba, University Magna Graecia
ClinicalTrials.gov Identifier:
NCT00461643
First received: April 13, 2007
Last updated: April 5, 2013
Last verified: April 2013

April 13, 2007
April 5, 2013
January 2007
December 2015   (final data collection date for primary outcome measure)
Multiple pregnancy rate [ Time Frame: 9 months ] [ Designated as safety issue: Yes ]
Multiple pregnancy rate
Complete list of historical versions of study NCT00461643 on ClinicalTrials.gov Archive Site
  • Ovulation rate [ Time Frame: 15 months ] [ Designated as safety issue: No ]
  • Pregnancy rate [ Time Frame: 15 months ] [ Designated as safety issue: No ]
  • Abortion rate [ Time Frame: 15 months ] [ Designated as safety issue: Yes ]
  • Live-birth rate [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • Adverse-events [ Time Frame: 15 ] [ Designated as safety issue: Yes ]
  • Ovulation rate
  • Pregnancy rate
  • Abortion rate
  • Live-birth rate
  • Adverse-events
Not Provided
Not Provided
 
Strategies for Ovulation Induction in Anovulatory Infertile Patients With PCOS
Comparison of Three Different Strategies for Treating Infertility in Anovulatory Women With Polycystic Ovary Syndrome: a Multicentre Randomized Controlled Clinical Trial

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.

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Anovulatory Infertility Related to Polycystic Ovary Syndrome
Drug: Clomiphene citrate, metformin, metformin plus clomiphene citrate, gonadotropins
  • Active Comparator: Strategy A
    clomiphene followed by clomiphene plus metformin followed by gonadotropins
    Intervention: Drug: Clomiphene citrate, metformin, metformin plus clomiphene citrate, gonadotropins
  • Active Comparator: Strategy B
    metformin followed by metformin plus clomiphene followed by gonadotropins
    Intervention: Drug: Clomiphene citrate, metformin, metformin plus clomiphene citrate, gonadotropins
  • Active Comparator: Strategy C
    metformin plus clomiphene followed by gonadotropins
    Intervention: Drug: Clomiphene citrate, metformin, metformin plus clomiphene citrate, gonadotropins

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
552
Not Provided
December 2015   (final data collection date for primary outcome measure)

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
Female
18 Years to 35 Years
Yes
Contact: Stefano Palomba, MD +39-0961.883234 stefanopalomba@tin.it
Italy
 
NCT00461643
01/2007
No
Stefano Palomba, University Magna Graecia
University Magna Graecia
Not Provided
Principal Investigator: Stefano Palomba, MD Department of Obstetrics and Gynecology, University "Magna Graecia" of Catanzaro
University Magna Graecia
April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP