Corifollitropin Alfa on D5 Versus D7 After Contraceptive Pill

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-02-28

Study Completion Date

2016-06-30

Brief Summary

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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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Detailed Description

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Conditions

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Oocyte Donation

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Day 5

Administration of corifollitropin alfa on Day 5 after last oral contraceptive pill in a GnRH antagonist protocol in donors.

Group Type EXPERIMENTAL

Corifollitropin alfa

Intervention Type DRUG

Day 7

Administration of corifollitropin alfa on Day 7 after last oral contraceptive pill in a GnRH antagonist protocol in donors.

Group Type ACTIVE_COMPARATOR

Corifollitropin alfa

Intervention Type DRUG

Interventions

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Corifollitropin alfa

Intervention Type DRUG

Eligibility Criteria

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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…)

Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes