A prospective randomized noninferiority study comparing recombinant FSH and highly purified menotropin in intrauterine insemination cycles in couples with unexplained infertility and/or mild-moderate male factor.
OBJECTIVE
To demonstrate the noninferiority of highly purified menotropin (HP-hMG) compared with recombinant FSH (rFSH) regarding clinical pregnancy rate (PR) in intrauterine insemination (IUI) cycles.


METHODS
Prospective randomized noninferiority trial.


METHODS
Unit of physiopathology of human reproduction, university hospital.


METHODS
Five hundred twenty-three patients with unexplained infertility or mild male infertility undergoing controlled ovarian hyperstimulation for IUI.


METHODS
Patients were randomized for treatment with rFSH (262 patients) or HP-hMG (261 patients). Insemination was performed 34-36 hours after hCG injection.


METHODS
The primary outcome was clinical pregnancy rate (PR). The secondary outcome was the number of interrupted cycles for high risk of ovarian hyperstimulation syndrome (OHSS) and multiple pregnancy.


RESULTS
The clinical PR was 19.7% (95% confidence interval [CI] 15.3%-25.1%) in the HP-hMG group and 21.4% (95% CI 16.9%-26.8%) in the rFSH group [absolute difference -1.7% (95% CI -8.6%-5.2%)]; therefore, the noninferiority was demonstrated. The number of interrupted cycles for OHSS risk and multiple pregnancy was significantLy higher in the rFSH group, 8.4% (95% CI 5.6%-12.4%) than in the HP-hMG group 1.2% (95% CI 0.4%-3.3%) [absolute difference -7.27% (95% CI -11.3 to -3.7)].


CONCLUSIONS
HP-hMG is not inferior compared with rFSH regarding clinical PR.
Sagnella
Francesca
F
Department of Obstetrics and Gynaecology, Università Cattolica del Sacro Cuore, Rome, Italy. francescasagnella@libero.it
Moro
Francesca
F
Lanzone
Antonio
A
Tropea
Anna
A
Martinez
Daniela
D
Capalbo
Antonio
A
Gangale
Maria Francesca
MF
Spadoni
Valentina
V
Morciano
Andrea
A
Apa
Rosanna
R
D000328:Adult; D000465:Algorithms; D005191:Family Characteristics; D005260:Female; D005300:Fertility Agents, Female / Q000627:therapeutic use; D005640:Follicle Stimulating Hormone / Q000627:therapeutic use*; D006801:Humans; D007246:Infertility / Q000628:therapy*; D007248:Infertility, Male / Q000145:classification / Q000628:therapy*; D007315:Insemination, Artificial / Q000379:methods; D008297:Male; D008596:Menotropins / Q000302:isolation & purification / Q000627:therapeutic use*; D008597:Menstrual Cycle / Q000502:physiology; D011247:Pregnancy; D018873:Pregnancy Rate; D011994:Recombinant Proteins / Q000627:therapeutic use; D012720:Severity of Illness Index; D014599:Uterus
D005300:Fertility Agents, Female; D011994:Recombinant Proteins; D008596:Menotropins; D005640:Follicle Stimulating Hormone