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


BACKGROUND
ClinicalTrials.gov Identifier NCT00374634.
la Cour Freiesleben
N
N
The Fertility Clinic, Section 4071, Copenhagen University Hospital, Rigshospitalet, 2100 Copenhagen, Denmark. ninalcf@hotmail.com
Lossl
K
K
Bogstad
J
J
Bredkjaer
H E
HE
Toft
B
B
Rosendahl
M
M
Loft
A
A
Bangsboll
S
S
Pinborg
A
A
Nyboe Andersen
A
A
D000328:Adult; D001835:Body Weight; D005260:Female; D043373:Follicle Stimulating Hormone, Human / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D006728:Hormones / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D006801:Humans; D007315:Insemination, Artificial / Q000379:methods*; D049451:Nomograms; D010053:Ovary / Q000187:drug effects; D010062:Ovulation Induction / Q000379:methods*; D011247:Pregnancy; D018873:Pregnancy Rate; D011994:Recombinant Proteins / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*
D043373:Follicle Stimulating Hormone, Human; D006728:Hormones; D011994:Recombinant Proteins