Clinical trial NCT02490150: Corifollitropin Alfa on D5 Versus D7 After Contraceptive Pill
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Oocyte Donation
Keywords: Corifollitropin alfa
Stimulation protocol
Lead sponsor: Fundacion Dexeus
Sponsor class: OTHER
Collaborators: name: Francisca Martínez
name: Buenaventura Coroleu
name: Elisabet Clua
name: Ignacio Rodríguez
First posted: 2015-07-03
Enrollment: 70
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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...)

Primary outcomes:
measure: total dosis of rFSH (IU)
timeFrame: donors will be followed until the end of stimulation period, an expected average of 15 days
Secondary outcomes:
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Hospital Quiron Dexeus
Study officials:
References:
citation: 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. doi: 10.1093/humrep/deu105. Epub 2014 May 9.