A double-blind, randomized, placebo-controlled study to assess the efficacy of ketoconazole for reducing the risk of ovarian hyperstimulation syndrome.
OBJECTIVE
To evaluate the role of ketoconazole in prevention of ovarian hyperstimulation syndrome (OHSS) in women with the polycystic ovary syndrome (PCOS) undergoing ovarian stimulation with gonadotropins.


METHODS
Prospective, randomized, double-blind, placebo-controlled study.


METHODS
University hospitals. One hundred nine women with PCOS who were referred for treatment with gonadotropins.


METHODS
Fifty patients were randomly assigned to receive two ampoules of hMG beginning on day 2 or 3 of the cycle and ketoconazole (50 mg every 48 hours) starting on the first day of hMG treatment. Fifty-one patients received the same amount of hMG plus one tablet of placebo every 48 hours.


METHODS
Follicular development, E(2) level, and pregnancy rate.


RESULTS
The total number of hMG ampoules and duration of treatment to attain ovarian stimulation were higher among ketoconazole recipients. The serum E(2) level and number of patients with dominant follicles on day 9 of the cycle were greater in placebo recipients. Serum E(2) level and total number of follicles at the time of hCG administration did not differ between the two groups. The cancellation rate and OHSS rate were similar in the two groups.


CONCLUSIONS
Ketoconazole does not prevent OHSS in patients with PCOS who are undergoing ovarian stimulation. It may reduce the rate of folliculogenesis and steroidogenesis.
Parsanezhad
Mohammad Ebrahim
ME
Shiraz University of Medical Sciences, Shiraz, Iran. parsame@sums.ac.ir
Alborzi
Saeed
S
Pakniat
Mahnaz
M
Schmidt
Ernst Heinrich
EH
D000328:Adult; D000726:Androgen Antagonists / Q000008:administration & dosage / Q000627:therapeutic use*; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D004359:Drug Therapy, Combination; D004958:Estradiol / Q000097:blood; D005260:Female; D005300:Fertility Agents, Female / Q000008:administration & dosage; D006801:Humans; D015994:Incidence; D007247:Infertility, Female / Q000188:drug therapy* / Q000209:etiology* / Q000503:physiopathology; D007654:Ketoconazole / Q000008:administration & dosage / Q000627:therapeutic use*; D008596:Menotropins / Q000008:administration & dosage; D006080:Ovarian Follicle / Q000187:drug effects / Q000503:physiopathology; D016471:Ovarian Hyperstimulation Syndrome / Q000453:epidemiology / Q000517:prevention & control*; D010062:Ovulation Induction / Q000379:methods; D010919:Placebos; D011085:Polycystic Ovary Syndrome / Q000150:complications*; D011247:Pregnancy; D018873:Pregnancy Rate; D017211:Treatment Failure
D000726:Androgen Antagonists; D005300:Fertility Agents, Female; D010919:Placebos; D004958:Estradiol; D008596:Menotropins; D007654:Ketoconazole