Evaluation of mixed protocols with Bravelle (human-derived FSH) and Repronex (hMG) to assess clinical efficacy (EMBRACE) in women undergoing in vitro fertilization.
OBJECTIVE
To compare the efficacy and safety of three different ratios of human-derived follicle-stimulating hormone/human menopausal gonadotropin (human-derived FSH:hMG, Bravelle and Repronex) mixed together in the same syringe and administered subcutaneously once daily, to in vitro fertilization (IVF) patients <34 years or 34 to 40 years of age.


METHODS
Two randomized, prospective, age stratified, IVF studies.


METHODS
Twenty-one academic and private clinics with experience in IVF/embryo transfer (ET).


METHODS
Infertile premenopausal women undergoing IVF-ET.


METHODS
Pituitary suppression with leuprolide acetate, randomization to one of three treatment groups, followed by gonadotropin stimulation (GS) for up to 15 days. The human-derived FSH:hMG ratios were the following: Group 1, a 1:1 ratio throughout; Group 2, a 3:0 ratio that was changed to 1:1 after GS day 5; Group 3, a 2:1 ratio that was increased to 3:1, 4:1, or 5:1 after GS day 5, as needed.


METHODS
Mean number of oocytes retrieved; peak estradiol levels; dose and duration of stimulation; implantation rates; adverse events; injection site pain; and pregnancy and live birth rates.


RESULTS
Overall, women <34 years had higher E(2) levels, more oocytes retrieved, and improved implantation and live birth rates compared with women 34 to 40 years old. Nonetheless, each ratio of human-derived FSH:hMG produced comparable implantation rates, and continuing pregnancy and take-home baby rates.


CONCLUSIONS
All three ratios of human-derived FSH:hMG in both age groups produced comparable pregnancy and live birth rates with similar safety results.
In Vitro Fertility Clinic, William Beaumont Hospital, Royal Oak, Michigan, USA.
William R
WR
Keye
Richard P
RP
Marrs
Jerome H
JH
Check
Vicki
V
Schnell
Mark
M
Surrey
Dennis C
DC
Marshall
D000328:Adult; D004624:Embryo Transfer; D004958:Estradiol / Q000097:blood; D005260:Female; D005300:Fertility Agents, Female / Q000627:therapeutic use*; D005307:Fertilization in Vitro; D005640:Follicle Stimulating Hormone / Q000627:therapeutic use*; D006801:Humans; D016729:Leuprolide / Q000627:therapeutic use; D009930:Organic Chemicals; D011247:Pregnancy / Q000706:statistics & numerical data*; D011994:Recombinant Proteins / Q000627:therapeutic use
D005300:Fertility Agents, Female; D009930:Organic Chemicals; D011994:Recombinant Proteins; C432248:Repronex; D004958:Estradiol; D005640:Follicle Stimulating Hormone; D016729:Leuprolide