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Metformin in Step-down Regimen Versus Conventional Low Dose Step-up Protocol in Patients With PCOS Undergoing IVF

Primary Purpose

Infertility, PCOS

Status
Unknown status
Phase
Phase 4
Locations
Italy
Study Type
Interventional
Intervention
Metformin, gonadotropins in step-down regimen
Placebo, gonadotropins in step-up regimen
Sponsored by
University of Modena and Reggio Emilia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Infertility

Eligibility Criteria

18 Years - 35 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • PCOS
  • Infertility
  • High responders

Exclusion Criteria:

  • Poor responders
  • Major medical conditions

Sites / Locations

  • "Pugliese" Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Experimental

Control

Arm Description

Metformin plus step-down protocol

Placebo and step-up protocol

Outcomes

Primary Outcome Measures

OHSS rate
Ovarian hyperstimulation syndrome

Secondary Outcome Measures

cancellation rate
rate of cancelled cycle for high risk of OHSS or low response
pregnancy rate
live-birth rate

Full Information

First Posted
September 19, 2011
Last Updated
July 11, 2013
Sponsor
University of Modena and Reggio Emilia
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1. Study Identification

Unique Protocol Identification Number
NCT01438190
Brief Title
Metformin in Step-down Regimen Versus Conventional Low Dose Step-up Protocol in Patients With PCOS Undergoing IVF
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2013
Overall Recruitment Status
Unknown status
Study Start Date
June 2013 (undefined)
Primary Completion Date
December 2013 (Anticipated)
Study Completion Date
December 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Modena and Reggio Emilia

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility, PCOS

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Experimental
Arm Type
Experimental
Arm Description
Metformin plus step-down protocol
Arm Title
Control
Arm Type
Active Comparator
Arm Description
Placebo and step-up protocol
Intervention Type
Drug
Intervention Name(s)
Metformin, gonadotropins in step-down regimen
Intervention Description
Metformin 850 mg cps, two cps daily for 12 weeks. gonadotropins 75IU f, step-down regimen, starting dose of 225 IU daily.
Intervention Type
Drug
Intervention Name(s)
Placebo, gonadotropins in step-up regimen
Intervention Description
Placebo cps, two cps daily. Gonadotropins 75IU f, step-up regimen, starting dose of 75 IU daily.
Primary Outcome Measure Information:
Title
OHSS rate
Description
Ovarian hyperstimulation syndrome
Time Frame
one month
Secondary Outcome Measure Information:
Title
cancellation rate
Description
rate of cancelled cycle for high risk of OHSS or low response
Time Frame
one month
Title
pregnancy rate
Time Frame
one month
Title
live-birth rate
Time Frame
nine months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: PCOS Infertility High responders Exclusion Criteria: Poor responders Major medical conditions
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stefano Palomba, MD
Organizational Affiliation
Department of Obstetrics and Gynecology, University "Magna Graecia" of Catanzaro
Official's Role
Principal Investigator
Facility Information:
Facility Name
"Pugliese" Hospital
City
Catanzaro
ZIP/Postal Code
88100
Country
Italy

12. IPD Sharing Statement

Learn more about this trial

Metformin in Step-down Regimen Versus Conventional Low Dose Step-up Protocol in Patients With PCOS Undergoing IVF

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