The goal of this multicenter, randomized, placebo-controlled, double-blind clinical trial is toto evaluate the efficacy and safety of a human menopausal gonadotropin (hMG) in the development of multiple follicles, pregnancy, and cumulative live birth as part of an Assisted Reproductive Technology (ART) cycle in in women with a diagnosis of infertility.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
659
daily subcutaneous injection
daily subcutaneous injection
HRC Fertility
Encino, California, United States
RECRUITINGIllume Fertility
Norwalk, Connecticut, United States
cumulative live birth rate
cumulative live birth rate following vitrified-thawed, single-euploid blastocyst transfer(s)
Time frame: 12 months
Positive pregnancy (serum β-human chorionic gonadotropin [hCG])
Time frame: 10 +/-2 days after Embryo transfer
Clinical pregnancy (intrauterine gestational sac with fetal heartbeat)
Time frame: 5 weeks ± 6 days post-embryo transfer
Ongoing pregnancy (intrauterine pregnancy with fetal heartbeat)
Time frame: 10 weeks ± 6 days post-embryo transfer (ET)
Live birth rate
Time frame: 9 months after ET
Number of oocytes retrieved per stimulation cycle
Time frame: 12-22 days after controlled ovarian stimulation start
Number of metaphase II (MII) oocytes retrieved
Time frame: 12-22 days after controlled ovarian stimulation start
Fertilization rate (proportion of MII oocytes with normal fertilization)
Time frame: 12-22 days after Controlled Ovarian stimulation start
Number of Day 5 blastocysts from oocyte retrievals from Period 1 and Period 2
Time frame: 12-22 days after controlled ovarian stimulation start
Total gonadotropin dose required per stimulation cycle
Time frame: 12-20 days after start Controlled ovarian stimulation
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Reproductive Associates of Delaware CCRM
Newark, Delaware, United States
NOT_YET_RECRUITINGIVF Florida Reproductive Associates
Margate, Florida, United States
RECRUITINGCenter for Reproductive Medicine
Winter Park, Florida, United States
RECRUITINGReproductive Biology Associates (RBA)
Atlanta, Georgia, United States
RECRUITINGFertility Institute of Hawaii
Honolulu, Hawaii, United States
RECRUITINGFertility Centers of Illinois
Chicago, Illinois, United States
RECRUITINGShady Grove Fertility - Rockville
Rockville, Maryland, United States
RECRUITINGBoston IVF
Waltham, Massachusetts, United States
RECRUITING...and 6 more locations
Serum estradiol concentration on the day of ovulation trigger
Time frame: 12-20 days after controlled ovarian stimulation start
Serum progesterone (P4) on Day 5 of stimulation
Time frame: 5 days after start controlled ovarian stimulation
Serum Follicular Stimulation Hormone (FSH) level on stimulation day 1, pre-dose
Time frame: 1 day of stimulation
Serum Luteinizing hormone (LH) level on stimulation day 1, pre-dose
Time frame: 1 day of stimulation
Serum human Chorionic Gonadotropin (hCG) level on stimulation day 1, pre-dose
Time frame: 1 day of stimulation
FSH level on stimulation day 1, 1-4 hours post dose
Time frame: 1 day of stimulation
LH level on stimulation day 1, 1-4 hours post dose
Time frame: 1 day of stimulation
hCG level on stimulation day 1, 1-4 hours post dose
Time frame: 1 day of stimulation
FSH level on stimulation day 5
Time frame: After 5 day of stimulation
LH level on stimulation day 5
Time frame: After 5 day of stimulation
hCG level on stimulation day 5
Time frame: After 5 day of stimulation
FSH level on last stimulation day
Time frame: 12-20 days after controlled ovarian stimulation start
LH level on last stimulation day
Time frame: 12-20 days after controlled ovarian stimulation start
hCG level on last stimulation day
Time frame: 12-20 days after controlled ovarian stimulation start
FSH level on oocytes retrieval day
Time frame: 12-22 days after controlled ovarian stimulation start
LH level on oocytes retrieval day
Time frame: 12-22 days after controlled ovarian stimulation start
hCG level on oocytes retrieval day
Time frame: 12-22 days after controlled ovarian stimulation start