Hum. Reprod. Advance Access originally published online on July 14, 2009
Human Reproduction 2009 24(10):2523-2530; doi:10.1093/humrep/dep239
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Individual versus standard dose of rFSH in a mild stimulation protocol for intrauterine insemination: a randomized study
1 The Fertility Clinic, Section 4071, Copenhagen University Hospital, Rigshospitalet, 2100 Copenhagen, Denmark 2 The Fertility Clinic, Copenhagen University Hospital, Hvidovre Hospital, 2650 Hvidovre, Denmark 3 The Fertility Clinic, Holbæk Sygehus, 4300, Holbæk, Denmark 4 The Fertility Clinic, Brædstrup Hospital, 8740 Brædstrup, Denmark
5 Correspondence address. E-mail: ninalcf{at}hotmail.com
BACKGROUND: Controlled ovarian stimulation (COS) and intrauterine insemination (IUI) are often used as the first-line treatment for subfertile couples. To minimize the variability in ovarian response in patients' first treatment cycle, we recently developed a recombinant follicle-stimulating hormone (rFSH) dosage nomogram. The nomogram has now been tested.
METHODS: Multicentre randomized controlled trial (RCT) including 228 ovulatory patients scheduled for COS and IUI. Patients were randomized to ‘individual’ (50–100 IU rFSH/day, n = 113) or ‘standard’ (75 IU rFSH/day, n = 115) dose. ‘Individual’ dose was prescribed according to the nomogram, which was based on patients' body weight and antral follicle count. The primary end-point was the proportion of patients with two to three follicles 
14 mm (maximum two follicles 18 mm) on the day of hCG (leading follicle = 18 mm). Primary analysis was made by intention-to-treat.
RESULTS: In the ‘individual’ group, 79/113 (70%) of the patients developed two to three follicles versus 64/115 (56%) in the ‘standard’ group [absolute difference = 14.3 percentage points; 95% confidence interval (CI) 2–26, P = 0.03; absolute difference = 14.4; 95% CI 2–27, P = 0.02, when adjusting for centre]. Among patients with two to three follicles, the proportion of patients with two follicles was 46/79 (58%) in the ‘individual’ group versus 34/64 (53%) in the ‘standard’ group, P = 0.54. Ongoing pregnancy rate was 23/113 (20%) in the ‘individual’ group and 21/115 (18%) in the ‘standard’ group and the rate of multiple gestations was 1/113 (1%) versus 5/115 (4%), P = 0.21.
CONCLUSIONS: This RCT is the first to clinically test a dosage nomogram in ovulatory IUI patients' first rFSH treatment cycle. Dosing according to the nomogram was superior to standard dosing.
Trial registration: ClinicalTrials.gov Identifier NCT00374634 [ClinicalTrials.gov] .
Key words: IUI/controlled ovarian stimulation/individual dosing/dosage nomogram/ovarian response
Submitted on March 25, 2009; resubmitted on June 4, 2009; accepted on June 10, 2009.
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