Metformin in Step-down Regimen Versus Conventional Low Dose Step-up Protocol in Patients With PCOS Undergoing IVF
NCT ID: NCT01438190
Last Updated: 2013-07-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
120 participants
INTERVENTIONAL
2013-06-30
2014-12-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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Experimental
Metformin plus step-down protocol
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.
Control
Placebo and step-up protocol
Placebo, gonadotropins in step-up regimen
Placebo cps, two cps daily. Gonadotropins 75IU f, step-up regimen, starting dose of 75 IU daily.
Interventions
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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.
Placebo, gonadotropins in step-up regimen
Placebo cps, two cps daily. Gonadotropins 75IU f, step-up regimen, starting dose of 75 IU daily.
Eligibility Criteria
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Inclusion Criteria
* Infertility
* High responders
Exclusion Criteria
* Major medical conditions
18 Years
35 Years
FEMALE
No
Sponsors
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University of Modena and Reggio Emilia
OTHER
Responsible Party
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Stefano Palomba
MD
Principal Investigators
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Stefano Palomba, MD
Role: PRINCIPAL_INVESTIGATOR
Department of Obstetrics and Gynecology, University "Magna Graecia" of Catanzaro
Locations
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"Pugliese" Hospital
Catanzaro, , Italy
Countries
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Other Identifiers
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09/2011
Identifier Type: -
Identifier Source: org_study_id
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