Corifollitropin Alfa on D5 Versus D7 After Contraceptive Pill

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.

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Key information

Conditions

Oocyte Donation

Age range

18 year–35 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Hospital Quiron Dexeus

Barcelona, 08028, Spain

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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…)

Treatment and study plan

Corifollitropin alfa

Drug

Primary outcomes

total dosis of rFSH (IU)

Time frame: donors will be followed until the end of stimulation period, an expected average of 15 days

Sponsors and collaborators

Lead sponsor

Fundacion Dexeus

Other

Collaborators

Buenaventura Coroleu
Elisabet Clua
Francisca Martínez
Ignacio Rodríguez

Registry information

Official study 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

Important dates

Study start: 2015
Primary completion: 2016
Study completion: 2016
First posted: Jul 3, 2015
Registry last updated: May 16, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed