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

NCT01438190 | Unknown Phase 4

• 1 other identifier: 09/2011
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Infertility; PCOS

Outcome Measures

Primary Outcomes (1)

• OHSS rate

  Ovarian hyperstimulation syndrome

  one month

Secondary Outcomes (3)

• cancellation rate

  one month

• pregnancy rate

  one month

• live-birth rate

  nine months

Study Arms (2)

Experimental

EXPERIMENTAL

Metformin plus step-down protocol

Drug: Metformin, gonadotropins in step-down regimen

Control

ACTIVE COMPARATOR

Placebo and step-up protocol

Drug: Placebo, gonadotropins in step-up regimen

Interventions

Metformin, gonadotropins in step-down regimen DRUG

Metformin 850 mg cps, two cps daily for 12 weeks. gonadotropins 75IU f, step-down regimen, starting dose of 225 IU daily.

Experimental

Placebo, gonadotropins in step-up regimen DRUG

Placebo cps, two cps daily. Gonadotropins 75IU f, step-up regimen, starting dose of 75 IU daily.

Control

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• PCOS
• Infertility
• High responders

You may not qualify if:

• Poor responders
• Major medical conditions

Sponsors & Collaborators

• University of Modena and Reggio Emilia: lead

Study Sites (1)

"Pugliese" Hospital

Catanzaro, 88100, Italy

Location

MeSH Terms

Conditions

Infertility

Interventions

Metformin; Gonadotropins

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

• Stefano Palomba, MD

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: September 19, 2011
• First Posted: September 22, 2011
• Study Start: June 1, 2013
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2014
• Last Updated: July 12, 2013

Record last verified: 2013-07

Locations

IT (1)