Does metformin affect the ovarian response to gonadotropins for in vitro
fertilization treatment in patients with polycystic ovary syndrome and reduced
ovarian reserve? A randomized controlled trial.
Author(s): Palomba S, Falbo A, Di Cello A, Cappiello F, Tolino A, Zullo F.
Affiliation(s): Department of Obstetrics and Gynecology, University Magna Graecia of Catanzaro,
Catanzaro, Italy. stefanopalomba@tin.it
Publication date & source: 2011, Fertil Steril. , 96(5):1128-33
OBJECTIVE: To evaluate the effects of metformin on the ovarian response to
gonadotropins given for in vitro fertilization (IVF) programs in patients with
polycystic ovary syndrome (PCOS) and reduced ovarian reserve.
DESIGN: Prospective, parallel, randomized, double-blind, placebo-controlled
clinical trial.
SETTING: Academic departments of obstetrics and gynecology, and a private IVF
center.
PATIENT(S): Primary infertile patients with PCOS older than 35 years and/or with
a basal follicle-stimulating hormone (FSH) level higher than 10 IU/L who were
scheduled for IVF cycles.
INTERVENTION(S): Gonadotropin-releasing hormone agonist flare-up protocol and
high starting doses of recombinant FSH plus metformin or placebo tablets.
MAIN OUTCOME MEASURE(S): Primary end point: cancellation rate for low ovarian
response. Secondary end-points: other clinical, biochemical, and reproductive
data.
RESULT(S): Enrollment was stopped after 88 participants had been randomized and
analyzed due to an unacceptable increased risk of poor ovarian response in the
metformin arm. Statistically significant differences between the metformin and
placebo groups were observed in the dose of gonadotropins used, peak estradiol
levels, and the number of dominant follicles, retrieved oocytes, and metaphase II
oocytes.
CONCLUSION(S): In patients with PCOS and reduced ovarian reserve, metformin
worsened the response to gonadotropins, and its administration should be stopped
before the start of controlled ovarian hyperstimulation for IVF programs.
CLINICAL TRIALS IDENTIFICATION NUMBER: NCT01208740.
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