Individual versus standard dose of rFSH in a mild stimulation protocol for intrauterine insemination: a randomized study

Nina la Cour Freiesleben, N la Cour Freiesleben, K Lossl, Kristine Løssl, Jeanette Bogstad, J Bogstad, H E Bredkjaer, H.E. Bredkjær, Birgitte Grønkær Toft, B Toft, M Rosendahl, Mikkel Rosendahl, A Loft, Anne Loft, S Bangsboll, Susanne Bangsbøll, A Pinborg, Anja Pinborg, A. Nyboe Andersen, Anders Nyboe Andersen
Human Reproduction · 2009 · vol. 24(10) , pp. 2523–2530 · doi:10.1093/humrep/dep239 · PMID:19602518 · W2152509683
RCT OA: closed CC0
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This randomized trial evaluated a recombinant follicle-stimulating hormone dosage nomogram in ovulatory women undergoing intrauterine insemination, finding that individualized dosing significantly improved the proportion of patients achieving optimal ovarian response compared to standard fixed-dose regimens.

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Abstract

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 > or = 14 mm (maximum two follicles > or = 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.

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MeSH descriptors

Follicle Stimulating Hormone, Human Hormones Insemination, Artificial Ovulation Induction Recombinant Proteins Adult Body Weight Female Follicle Stimulating Hormone, Human Follicle Stimulating Hormone, Human Follicle Stimulating Hormone, Human Hormones Hormones Hormones Humans Insemination, Artificial Nomograms Ovary Ovary Ovulation Induction

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