A prospective, randomized, controlled trial comparing highly purified hMG with recombinant FSH in women undergoing ICSI: ovarian response and clinical outcomes.
BACKGROUND
To assess the clinical profile and efficacy in assisted reproductive treatment of a new human-derived highly purified (HP) menotropin, we compared HP hMG and recombinant (r) FSHalpha use in ICSI within a prospective, randomized, controlled study.


METHODS
100 infertile women were treated with HP hMG (50 patients) or rFSHalpha (50 patients). All patients received the same daily gonadotrophin dose (150 IU) following GnRH agonist suppression (long regimen) until more than three follicles >17 mm and estradiol (E(2)) levels >600 pg/ml were reached. Patients were monitored with daily LH, FSH, hCG, estradiol (E(2)), progesterone, and testosterone measurements; and alternate day pelvic ultrasound.


RESULTS
Treatment duration (11.1 +/- 0.4 versus 12.9 +/- 0.5 days, P < 0.05) and gonadotrophin dose (22.4 +/- 1.0 versus 27.0 +/- 1.5 ampoules, P < 0.05) were lower in the HP hMG group. Conversely, peak pre-ovulatory E(2) (1342 +/- 127 versus 933 +/- 109 pg/ml, P < 0.005); and area under the curve of E(2) (3491 +/- 350 versus 2602 +/- 349 pg/ml.day, P < 0.05), immunoreactive serum FSH (65.9 +/- 2.1 versus 48.8 +/- 1.8 IU/l.day, P < 0.001). and hCG (1.7 +/- 0.3 versus 0.0 +/- 0.0 IU/l/day, P < 0.001) during treatment were higher in the HP hMG group. Cycle cancellation rates, transferred embryo number, pregnancy rates per started cycle (30 versus 28%) and per embryo transfer (35 versus 35%) and miscarriage rates (6 versus 6%) were not significantly different.


CONCLUSIONS
HP hMG treatment was associated with: (i) a more efficient patient response, as reflected by reduced treatment duration and gonadotrophin requirements; (ii) increased serum levels of hCG, E(2), and immunoreactive FSH during treatment; (iii) an ICSI outcome indistinguishable from rFSHalpha.
Kilani
Z
Z
Farah Hospital, Amman, Jordan and Reproductive Endocrinology Center, University of Bologna, Via Massarenti 13 40138, Italy.
Dakkak
A
A
Ghunaim
S
S
Cognigni
G E
GE
Tabarelli
C
C
Parmegiani
L
L
Filicori
M
M
D000022:Abortion, Spontaneous / Q000453:epidemiology; D000328:Adult; D006063:Chorionic Gonadotropin / Q000097:blood; D004624:Embryo Transfer; D004958:Estradiol / Q000097:blood; D005260:Female; D005640:Follicle Stimulating Hormone / Q000097:blood; D015292:Glycoprotein Hormones, alpha Subunit / Q000008:administration & dosage*; D006801:Humans; D007986:Luteinizing Hormone / Q000097:blood; D008596:Menotropins / Q000008:administration & dosage*; D010062:Ovulation Induction; D011247:Pregnancy; D011374:Progesterone / Q000097:blood; D011446:Prospective Studies; D011994:Recombinant Proteins / Q000008:administration & dosage; D020554:Sperm Injections, Intracytoplasmic / Q000379:methods*; D013739:Testosterone / Q000097:blood; D016896:Treatment Outcome
D006063:Chorionic Gonadotropin; D015292:Glycoprotein Hormones, alpha Subunit; D011994:Recombinant Proteins; D013739:Testosterone; D011374:Progesterone; D004958:Estradiol; D008596:Menotropins; D007986:Luteinizing Hormone; D005640:Follicle Stimulating Hormone