TY - JOUR
T1 - Individual versus standard dose of rFSH in a mild stimulation protocol for intrauterine insemination: a randomized study
AU - la Cour Freiesleben, N
AU - Lossl, K
AU - Bogstad, J
AU - Bredkjaer, H E
AU - Toft, B
AU - Rosendahl, M
AU - Loft, A
AU - Bangsboll, S
AU - Pinborg, A
AU - Nyboe Andersen, A
AU - la Cour Freiesleben, N
AU - Løssl, Kristine
AU - Bogstad, J
AU - Bredkjaer, H E
AU - Toft, Bente
AU - Rosendahl, M
AU - Loft, A
AU - Bangsbøll-Andersen, Susanne
AU - Pinborg, A
AU - Andersen, Anders Nyboe
N1 - Keywords: Adult; Body Weight; Female; Follicle Stimulating Hormone, Human; Hormones; Humans; Insemination, Artificial; Nomograms; Ovary; Ovulation Induction; Pregnancy; Pregnancy Rate; Recombinant Proteins
PY - 2009/10/1
Y1 - 2009/10/1
N2 - 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.
AB - 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.
U2 - 10.1093/humrep/dep239
DO - 10.1093/humrep/dep239
M3 - Journal article
C2 - 19602518
SN - 0268-1161
VL - 24
SP - 2523
EP - 2530
JO - Human Reproduction
JF - Human Reproduction
IS - 10
ER -