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Metformin in Step-down Regimen Versus the Conventional Low Dose Step-up Protocol in Patients With Polycystic Ovary Syndrome Undergoing in Vitro Fertilization

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Stefano Palomba, University Magna Graecia
ClinicalTrials.gov Identifier:
NCT01438190
First received: September 19, 2011
Last updated: April 5, 2013
Last verified: April 2013
History of Changes

September 19, 2011
April 5, 2013
June 2013
December 2013   (final data collection date for primary outcome measure)
OHSS rate [ Time Frame: one month ] [ Designated as safety issue: Yes ]
Ovarian hyperstimulation syndrome
Same as current
Complete list of historical versions of study NCT01438190 on ClinicalTrials.gov Archive Site
  • cancellation rate [ Time Frame: one month ] [ Designated as safety issue: Yes ]
    rate of cancelled cycle for high risk of OHSS or low response
  • pregnancy rate [ Time Frame: one month ] [ Designated as safety issue: No ]
  • live-birth rate [ Time Frame: nine months ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Metformin in Step-down Regimen Versus the Conventional Low Dose Step-up Protocol in Patients With Polycystic Ovary Syndrome Undergoing in Vitro Fertilization
A Comparison Study of a Novel Stimulation Protocol With Metformin in Step-down Regimen and the Conventional Low Dose Step-up Protocol in Patients With Polycystic Ovary Syndrome Undergoing in Vitro Fertilization

Because many women with Polycystic Ovary Syndrome (PCOS) are very sensitive to the use of gonadotropins, several strategies have been proposed to reduce the risk of Ovarian hyperstimulation syndrome (OHSS) and multiple pregnancies.

The low dose step-up protocol and the step-down protocols in PCOS patients have been described in literature.

The step-down regimen is designed to achieve the follicle stimulating hormone (FSH) threshold through a loading dose of FSH with a subsequent stepwise reduction as soon as follicular development is observed on ultrasound. On the contrary the step-up regimen is based upon the principle of a stepwise increase in FSH supply to determine the FSH threshold for follicular development. After commencement of gonadotropin administration, if follicle development is not observed on ultrasound after 1 week, an increase in the dose is recommended. Once follicle growth is observed, the same FSH dose is maintained until follicular selection is achieved.

Preliminary studies report that both step-up and step-down regimens achieve similar high rates of monofollicular development. However, the largest study published so far has shown that the step-up regimen is safer in terms of monofollicular development.

Recent data demonstrate that metformin administration in infertile PCOS patients who are at high-risk for OHSS reduces the incidence and severity of OHSS during gonadotropin ovarian stimulation in a step-down regimen for in vitro fertilization (IVF) programs.

The aim of the present study will be to compare the conventional low dose step-up protocol and the combined protocol consisting in metformin and gonadotropin step-down regimen.
Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Prevention
  • Infertility
  • PCOS
  • Drug: Metformin, gonadotropins in step-down regimen
    Metformin 850 mg cps, two cps daily for 12 weeks. gonadotropins 75IU f, step-down regimen, starting dose of 225 IU daily.
  • Drug: Placebo, gonadotropins in step-up regimen
    Placebo cps, two cps daily. Gonadotropins 75IU f, step-up regimen, starting dose of 75 IU daily.
  • Experimental: Experimental
    Metformin plus step-down protocol
    Intervention: Drug: Metformin, gonadotropins in step-down regimen
  • Active Comparator: Control
    Placebo and step-up protocol
    Intervention: Drug: Placebo, gonadotropins in step-up regimen
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
120
Not Provided
December 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • PCOS
  • Infertility
  • High responders

Exclusion Criteria:

  • Poor responders
  • Major medical conditions
Female
18 Years to 35 Years
No
Contact information is only displayed when the study is recruiting subjects
Italy
 
NCT01438190
09/2011
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