Corifollitropin Alfa on D5 Versus D7 After Contraceptive Pill

Institut Universitari Dexeus

Status and phase

Completed

Phase 4

Conditions

Oocyte Donation

Treatments

Drug: Corifollitropin alfa

Study type

Interventional

Funder types

Other

Identifiers

NCT02490150

HDQ-COR-2014-01

Details and patient eligibility

About

To evaluate if the administration of corifollitropin alfa on day 7 instead of on day 5 after pre-treatment with oral contraceptive pill results in a reduced total rFSH (recombinant follicle stimulating hormone ) consumption in a GnRH antagonist protocol in donors.

Enrollment

70 patients

Sex

Female

Ages

18 to 35 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Women 18-35 y old ,with regular spontaneous menstrual cycles of 25-30 days length
Who had vaginal sexual intercourse or have no inconvenient for vaginal explorations
Donors can´t have more than 6 children (neither own or after donations)
Not be adopted or being born after a gamete donation pregnancy
BMI between 18-28 kg/m2
Height > 1.55cm
Gynecological and general examination with Pap smear, HIV, HCV (hepatitis C virus ), HBV (hepatitis B virus ) and RPR(rapid plasma reagin test ) negative serology, and with normal karyotype
No abnormal Psychological profile
Discard any disease: blood disorders, neurodegenerative/psychiatric diseases, Fragile X Syndrome, cystic fibrosis carrier, oncology diseases.
Without psychological/psychiatric family history
Will conform to the protocol for the duration of the study
Willingness of adhesion to protocol during the whole study period
Signed informed consent

Exclusion criteria

Polycystic ovarian syndrome
Antral follicle count > 20
Hypersensitivity to the active substance or any of the excipients
Abnormal vaginal bleeding of unknown ethiology
Presence of ovarian cysts or increased size ovaries
History of ovarian hyperstimulation syndrome
Previous controlled ovarian stimulation cycle with more than 30 follicles ≥ 11mm
Previous abdominal surgery that contraindicated the practice of follicular puncture
HIV, HCV, HBV positive serology in women or partner
Important systemic diseases that could interfere with gonadotrophin treatment (ovarian and hypothalamic tumors...)