Corifollitropin Alfa on D5 Versus D7 After Contraceptive Pill

Oocyte Donation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02490150
• Other study ID #: HDQ-COR-2014-01
• Status: Completed
• Phase: Phase 4
• First received: June 22, 2015
• Last updated: May 15, 2017
• Start date: February 2015
• Est. completion date: June 2016

Study information

• Verified date: May 2017
• Source: Institut Universitari Dexeus
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: June 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 35 Years

Eligibility

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…)

Related Conditions & MeSH terms

• Oocyte Donation

Intervention

Drug:
• Corifollitropin alfa

Locations

Country	Name	City	State
Spain	Hospital Quiron Dexeus	Barcelona

Sponsors (5)

Lead Sponsor	Collaborator
Institut Universitari Dexeus	Buenaventura Coroleu, Elisabet Clua, Francisca Martínez, Ignacio Rodríguez

Country where clinical trial is conducted

Spain, 

References & Publications (1)

Blockeel C, Polyzos NP, Derksen L, De Brucker M, Vloeberghs V, van de Vijver A, De Vos M, Tournaye H. Administration of corifollitropin alfa on Day 2 versus Day 4 of the cycle in a GnRH antagonist protocol: a randomized controlled pilot study. Hum Reprod. 2014 Jul;29(7):1500-7. Epub 2014 May 9. — View Citation

Outcome

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