NCT02490150

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Feb 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2015

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

June 22, 2015

Completed
11 days until next milestone

First Posted

Study publicly available on registry

July 3, 2015

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
Last Updated

May 16, 2017

Status Verified

May 1, 2017

Enrollment Period

1.3 years

First QC Date

June 22, 2015

Last Update Submit

May 15, 2017

Conditions

Oocyte Donation

Keywords

Corifollitropin alfaStimulation protocol

Outcome Measures

Primary Outcomes (1)

  • total dosis of rFSH (IU)

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

Study Arms (2)

Day 5

EXPERIMENTAL

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

Drug: Corifollitropin alfa

Day 7

ACTIVE COMPARATOR

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

Drug: Corifollitropin alfa

Interventions

Corifollitropin alfaDRUG
Day 5Day 7

Eligibility Criteria

Age18 Years - 35 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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…)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Quiron Dexeus

Barcelona, 08028, Spain

Location

Related 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. doi: 10.1093/humrep/deu105. Epub 2014 May 9.

    PMID: 24813196BACKGROUND

MeSH Terms

Interventions

follicle stimulating hormone, human, with HCG C-terminal peptide

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD.

Study Record Dates

First Submitted

June 22, 2015

First Posted

July 3, 2015

Study Start

February 1, 2015

Primary Completion

June 1, 2016

Study Completion

June 1, 2016

Last Updated

May 16, 2017

Record last verified: 2017-05

Locations

ES(1)