Corifollitropin Alfa on D5 Versus D7 After Contraceptive Pill

Administration of Corifollitropin Alfa on Day 5 Versus Day 7 After Last Oral Contraceptive Pill in a GnRH (Gonadotropin-releasing Hormone ) Antagonist Protocol in Donors

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02490150

Enrollment

Registered

2015-07-03

Start date

2015-02-28

Completion date

2016-06-30

Last updated

2017-05-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Oocyte Donation

Keywords

Corifollitropin alfa, Stimulation protocol

Brief summary

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.

Interventions

DRUGCorifollitropin alfa

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 35 Years

Healthy volunteers

Yes

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…)

Design outcomes

Primary

Measure	Time frame
total dosis of rFSH (IU)	donors will be followed until the end of stimulation period, an expected average of 15 days

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026