NCT02213627

Brief Summary

The purpose of this study is to determine if corifollitropin alfa (long-term gonadotropin administration) is effective in a controlled ovarian stimulation protocol in oocyte donors compared to daily gonadotropin administration (recombinant FSH or HP-hMG)

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Oct 2014

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

August 8, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 11, 2014

Completed
2 months until next milestone

Study Start

First participant enrolled

October 1, 2014

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2015

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

July 17, 2015

Status Verified

July 1, 2015

Enrollment Period

11 months

First QC Date

August 8, 2014

Last Update Submit

July 16, 2015

Conditions

Female Reproductive ProblemInfertility

Keywords

Corifollitropin alfa, recombinant FSH, HP-hMG, apoptosis, oocyte donation

Outcome Measures

Primary Outcomes (1)

  • Number of oocytes and mature oocytes

    3 months

Secondary Outcomes (5)

  • Fertilization and implantation rates

    3 months

  • Drop-out rate and cancellation rate

    3 months

  • Cost-effectiveness analysis

    6 months

  • Endocrine profile in serum and follicular fluid

    3 months

  • Apoptosis rate in cumulus cells

    6 months

Study Arms (3)

Corifollitropin alfa

EXPERIMENTAL

From day 2-3 of mense, a single 100 microgram dose of corifollitropin alfa is administered. Daily doses of 0.25 mg GnRH antagonist will start on day 6 of stimulation and a single dose of 0.2 mg of GnRH agonist will be administered for triggering final oocyte maturation.

Drug: Corifollitropin alfa

Recombinant FSH

EXPERIMENTAL

From day 2-3 of mense, daily injections of 150 IU of recombinant FSH will be administered. Daily doses of 0.25 mg GnRH antagonist will start on day 6 of stimulation and a single dose of 0.2 mg of GnRH agonist will be administered for triggering final oocyte maturation.

Drug: Recombinant FSH

HP-hMG

EXPERIMENTAL

From day 2-3 of mense, daily doses of 225 IU of HP-hMG will be administered. Daily doses of 0.25 mg GnRH antagonist will start on day 6 of stimulation and a single dose of 0.2 mg of GnRH agonist will be administered for triggering final oocyte maturation.

Drug: HP-hMG

Interventions

Corifollitropin alfaDRUG
Also known as: Elonva 100 micrograms
Corifollitropin alfa
Recombinant FSHDRUG
Also known as: Puregon 50 IU
Recombinant FSH
HP-hMGDRUG
Also known as: Menopur 600 IU
HP-hMG

Eligibility Criteria

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

You may qualify if:

  • Women aged 18-35 years who meet the entry criteria for the IVI Donor Program:
  • Weight \< 60 Kg
  • Women with at least 6 antral follicles per ovary
  • Women who will fit the protocoo during the period of the study
  • Women who give written consent to participate in the test

You may not qualify if:

  • Women with basal antral follicle count above 20 or below 6.
  • Women with comorbidities, in the judgement of the investigator, that may interfere with the trearment of ovarian stimulation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

IVI Madrid

Madrid, Madrid, 28023, Spain

RECRUITING

MeSH Terms

Conditions

Infertility

Interventions

follicle stimulating hormone, human, with HCG C-terminal peptidefollitropin betaMenotropins

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Intervention Hierarchy (Ancestors)

Gonadotropins, PituitaryGonadotropinsPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPituitary Hormones, AnteriorPituitary HormonesPeptidesAmino Acids, Peptides, and ProteinsBiological ProductsComplex Mixtures

Study Officials

  • Antonio Requena, MD, PhD

    IVI Madrid

    PRINCIPAL INVESTIGATOR

  • Manuel Muñoz, MD, PhD

    Instituto Valenciano de Infertilidad, IVI Alicante

    STUDY CHAIR

  • Pilar Alamá, MD, PhD

    IVI Valencia

    STUDY CHAIR

  • María Cruz, PhD

    IVI Madrid

    STUDY CHAIR

Central Study Contacts

Antonio Requena, MD, PhD

CONTACT

+34 911802900Antonio.Requena@ivi.es

María Cruz, PhD

CONTACT

+34 911802900Maria.Cruz@ivi.es

Study Design

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

Study Record Dates

First Submitted

August 8, 2014

First Posted

August 11, 2014

Study Start

October 1, 2014

Primary Completion

September 1, 2015

Study Completion

December 1, 2015

Last Updated

July 17, 2015

Record last verified: 2015-07

Locations

ES(1)