Metformin reduces risk of ovarian hyperstimulation syndrome in patients with polycystic ovary syndrome during gonadotropin-stimulated in vitro fertilization cycles: a randomized, controlled trial

Objective To test whether metformin administration reduces the incidence of ovarian hyperstimulation syndrome (OHSS) in infertile high-risk patients with polycystic ovary syndrome (PCOS) who have been treated with gonadotropins for IVF. Design Parallel, randomized, double-blind, placebo-controlled c...

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Bibliographic Details
Published in:Fertility and sterility 2011-12, Vol.96 (6), p.1384-1390.e4
Main Authors: Palomba, Stefano, M.D, Falbo, Angela, M.D, Carrillo, Laura, M.D, Villani, Maria Teresa, M.D, Orio, Francesco, M.D, Russo, Tiziana, M.D, Di Cello, Annalisa, M.D, Cappiello, Fulvio, M.D, Capasso, Sabina, M.D, Tolino, Achille, M.D, Colao, Annamaria, M.D, Mastrantonio, Pasquale, M.D, La Sala, Giovanni Battista, M.D, Zullo, Fulvio, M.D, Cittadini, Ettore, M.D
Format: Article
Language:English
Subjects:
Administration, Oral
Adult
animal ovaries
Biological and medical sciences
Birth control
clinical trials
confidence interval
Double-Blind Method
Down-Regulation - drug effects
Drug Administration Schedule
Female
Female genital diseases
Fertilization in Vitro - methods
Gonadotropins
Gonadotropins - therapeutic use
Gynecology. Andrology. Obstetrics
Humans
Hypoglycemic Agents - administration & dosage
Hypoglycemic Agents - pharmacology
Hypoglycemic Agents - therapeutic use
in vitro fertilization
infertility
Internal Medicine
IVF
Medical sciences
metformin
Metformin - administration & dosage
Metformin - pharmacology
Metformin - therapeutic use
Non tumoral diseases
Obstetrics and Gynecology
OHSS
Ovarian Hyperstimulation Syndrome - epidemiology
Ovarian Hyperstimulation Syndrome - etiology
Ovarian Hyperstimulation Syndrome - prevention & control
Ovulation Induction - methods
patients
PCOS
Placebos
polycystic ovary syndrome
Polycystic Ovary Syndrome - complications
Polycystic Ovary Syndrome - drug therapy
Pregnancy
relative risk
Risk Factors
sterility
Sterility. Assisted procreation
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Summary:Objective To test whether metformin administration reduces the incidence of ovarian hyperstimulation syndrome (OHSS) in infertile high-risk patients with polycystic ovary syndrome (PCOS) who have been treated with gonadotropins for IVF. Design Parallel, randomized, double-blind, placebo-controlled clinical trial. Setting Academic departments, general hospital, and IVF centers. Patient(s) One hundred twenty patients with PCOS at high risk for OHSS. Intervention(s) Gonadotropins ovarian stimulation for IVF and metformin (500 mg three times daily) or placebo tablets (three times daily). Main Outcome Measure(s) The primary end point of the current clinical trial was the rate of OHSS. Anthropometric and reproductive data were evaluated. Result(s) The total OHSS and cancellation rates were significantly reduced in patients treated with metformin. The relative risk for OHSS was of 0.28 (95% confidence interval, 0.11–0.67). With metformin the stimulation length and the total amount of gonadotropins used were significantly increased, whereas the peak E2 levels were significantly reduced. Conclusion(s) In patients with PCOS who are at high risk for OHSS and who have been stimulated with gonadotropins for IVF cycles, metformin reduces the risk of OHSS by modulating the ovarian response to the stimulation. Registration ID number from clinicaltrials.gov NCT01233206.
ISSN:0015-0282
1556-5653
DOI:10.1016/j.fertnstert.2011.09.020