Corifollitropin Alfa on D5 Versus D7 After Contraceptive Pill

Phase 4

Completed

• Conditions: Oocyte Donation
• Interventions: Drug: Corifollitropin alfa

• Registration Number: NCT02490150
• Lead Sponsor: Institut Universitari Dexeus

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-02
• Study First Submitted: 2015-06-22
• Study First Submitted QC: 2015-07-01
• Study First Posted: 2015-07-03
• Primary Completion: 2016-06
• Study Completion: 2016-06
• Status Verified: 2017-05
• Last Update Submitted: 2017-05-15
• Last Update Posted: 2017-05-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 70

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...)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Day 5	Corifollitropin alfa	Administration of corifollitropin alfa on Day 5 after last oral contraceptive pill in a GnRH antagonist protocol in donors.
Day 7	Corifollitropin alfa	Administration of corifollitropin alfa on Day 7 after last oral contraceptive pill in a GnRH antagonist protocol in donors.

Primary Outcome Measures

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

Trial Locations

Locations (1)

Hospital Quiron Dexeus; 🇪🇸 Barcelona, Spain