Growth Hormone for Poor Responders in in Vitro Fertilization (IVF)

PHASE2CompletedINTERVENTIONAL
Enrollment

38

Participants

Timeline

Start Date

September 30, 2010

Primary Completion Date

May 31, 2015

Study Completion Date

May 31, 2015

Conditions
InfertilityPoor Ovarian Reserve
Interventions
DRUG

Growth Hormone

Subjects in this trial will use a 3.33mg vial (1 vial =10 IU) by daily subcutaneous injection. This will start on day 1 of the menstrual cycle preceding the stimulation phase of an IVF cycle, and will continue until the day of the human chorionic gonadotropin (hCG) trigger (approximately 5-6 weeks)

DRUG

Patch protocol

"Group A (n=10; control group) will receive patch protocol: 100ug estrogen patch (Estradot), Gonadotropin releasing hormone (GnRH) antagonist (Cetrotide; 0.25mg/d), gonadotropin stimulation 412 IU recombinant follicle stimulating hormone (r-FSH; Gonal F) and 150 IU of recombinant luteinizing hormone (r-LH; Luveris). With 3 or more follicles at mean diameter equal to or greater than 17mm, urinary human chorionic gonadotropin (u-hCG) 10,000 IU self-injected to complete final maturation of oocytes. Egg retrieval will occur 36 hours after hCG injection. Eggs fertilized by standard IVF or intra-cytoplasmic sperm injection (ICSI) depending on semen parameters. Embryos cultured to day 2 and the best 2-4 will be transferred back under ultrasound guidance. Surplus embryos will be frozen as per clinic protocol. Luteal support: Endometrin 100mg vaginally three times daily, starting on the day of egg retrieval and continuing until menses or positive serum beta-hCG, then stopped."

Trial Locations (1)

K2C 3V4

Ottawa Fertililty Centre, Ottawa

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

EMD Serono

INDUSTRY

lead

Ottawa Fertility Centre

OTHER

NCT01204840 - Growth Hormone for Poor Responders in in Vitro Fertilization (IVF) | Biotech Hunter | Biotech Hunter