Corifollitropin Alfa on D5 Versus D7 After Contraceptive Pill

May 15, 2017 updated by: Ignacio Rodriguez, Institut Universitari Dexeus

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

70

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Barcelona, Spain, 08028
        • Hospital Quiron Dexeus

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 35 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Day 5
Administration of corifollitropin alfa on Day 5 after last oral contraceptive pill in a GnRH antagonist protocol in donors.
Drug: Corifollitropin alfa
ACTIVE_COMPARATOR: Day 7
Administration of corifollitropin alfa on Day 7 after last oral contraceptive pill in a GnRH antagonist protocol in donors.
Drug: Corifollitropin alfa

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
total dosis of rFSH (IU)
Time Frame: donors will be followed until the end of stimulation period, an expected average of 15 days
donors will be followed until the end of stimulation period, an expected average of 15 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institut Universitari Dexeus

Collaborators

Francisca Martínez
Buenaventura Coroleu
Elisabet Clua
Ignacio Rodríguez

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

February 1, 2015

Primary Completion (ACTUAL)

June 1, 2016

Study Completion (ACTUAL)

June 1, 2016

Study Registration Dates

First Submitted

June 22, 2015

First Submitted That Met QC Criteria

July 1, 2015

First Posted (ESTIMATE)

July 3, 2015

Study Record Updates

Last Update Posted (ACTUAL)

May 16, 2017

Last Update Submitted That Met QC Criteria

May 15, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • HDQ-COR-2014-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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