Growth Hormone in Poor Responders to IVF Trial

PHASE2/PHASE3TerminatedINTERVENTIONAL
Enrollment

60

Participants

Timeline

Start Date

June 30, 2012

Primary Completion Date

June 30, 2015

Study Completion Date

August 31, 2015

Conditions
Infertility
Interventions
DRUG

Saizen (Human Growth Hormone)

Subjects will receive the standard protocol treatment, as well as adjuvant GH. One 3.33 mg vial Human Growth Hormone(10 IU Saizen®) will be self-administered daily by subcutaneous injection. GH treatment will start 14 days before FSH start and will continue until the day of the HCG treatment.

DRUG

Saizen (Human Growth Hormone)

Subjects will receive the standard IVF treatment, as well as adjuvant GH as above. One 3.33 mg vial Human Growth Hormone(10 IU Saizen®) will be self-administered daily by subcutaneous injection. GH treatment will start on the same day as the FSH start and will continue until the day of HCG treatment.

DRUG

No Saizen Control (Standard IVF Protocol)

All patients will be administered an oral contraceptive (Marvelon®). FSH treatment (daily subcutaneous injections of 450 IU Gonal-F®; Serono Canada) must begin 4 days after OCP stop, providing both of the following criteria are met. Pituitary downregulation with GnRH antagonist (Cetrotide®, Serono Canada) 0.25mg daily (subcutaneous injection) and LH (Luveris®, Serono Canada) 75 IU daily (subcutaneous injection) will be initiated when one or both of the following criteria are satisfied. Monitoring will continue until a lead follicle reaches ≥18 mm, at which time HCG (Ovidrel®, Serono Canada) 250 mcg will be administered by subcutaneous injection. Oocytes will be retrieved 36 hours after HCG treatment. Luteal support for the endometrium (90 mg progesterone (8% progesterone gel; Crinone® gel), administered intravaginally once daily) will begin one day after oocyte retrieval and will be maintained at least until day 31 of gestation.

Trial Locations (1)

V5G 4X7

Pacific Centre for Reproductive Medicine, Burnaby

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

EMD Serono

INDUSTRY

lead

Pacific Centre for Reproductive Medicine

NETWORK

NCT01616225 - Growth Hormone in Poor Responders to IVF Trial | Biotech Hunter | Biotech Hunter