NCT02254928

Brief Summary

A randomised, crossover, multicentre, national, clinical trial comparing the efficacy of corifollitropin alfa versus daily recombinant FSH and HMG in the controlled ovarian stimulation of women with a poor ovarian response undergoing IVF treatments. The main objective of this study is comparing the number of oocytes obtained after the follicle puncture when using each of these two stimulation protocols. Only poor responders according to the Bologna criteria will be recruited for this trial. All participants will undergo two stimulation cycles to obtain and accumulate oocytes by vitrification. One of the cycles will be done with the corifollitropin alfa protocol and the other with daily rFSH and HMG, the order of application of these protocols will be randomised (crossover clinical trial) in each patient.

Trial Health

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Trial Health Score

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

Enrollment
26

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Sep 2014

Geographic Reach
1 country

4 active sites

Status
terminated

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2014

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

September 25, 2014

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 2, 2014

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2015

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2015

Completed
Last Updated

January 18, 2016

Status Verified

January 1, 2016

Enrollment Period

10 months

First QC Date

September 25, 2014

Last Update Submit

January 15, 2016

Conditions

Infertility

Keywords

poor ovarian responsecontrolled ovarian stimulationrandomised clinical trialcorifollitropin alfarecombinant follicle-stimulating hormone (rFSH)human menopausal gonadotropin (HMG)

Outcome Measures

Primary Outcomes (1)

  • Number of mature oocytes (metaphase II)

    Number of mature oocytes (metaphase II) obtained after the follicle puncture

    1 year

Secondary Outcomes (5)

  • Total number of oocytes

    1 year

  • Symptoms associated with the ovarian stimulation protocol

    1 year

  • Patient perception of the stimulation treatment

    1 year

  • Length of the stimulation treatment

    1 year

  • Number of subcutaneous injections

    1 year

Study Arms (2)

Group 1

OTHER

First stimulation cycle with corifollitropin alfa (experimental) Second stimulation cycle with rFSH and HMG (active comparator)

Drug: Corifollitropin alfa

Group 2

OTHER

First stimulation cycle with rFSH and HMG (active comparator) Second stimulation cycle with corifollitropin alfa (experimental)

Drug: Corifollitropin alfa

Interventions

Corifollitropin alfaDRUG

One dose of 150 μg of corifollitropin alfa will be administered at day 1 of stimulation. Stimulation will be continued with 250-300 IU/day of rFSH from day 8 forward.

Also known as: Elonva
Group 1Group 2

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Advanced maternal age (≥40 years)
  • A previous poor ovarian response (≤3 oocytes with a conventional stimulation protocol)
  • An abnormal ovarian reserve test (i.e. antral follicle count \<5-7 follicles or anti-mullerian hormone level \<0.5-1.1 ng/ml)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

IVI Barcelona

Barcelona, Barcelona, 08017, Spain

Location

IVI Madrid

Madrid, Madrid, 28023, Spain

Location

IVI Sevilla

Seville, Seville, 41006, Spain

Location

IVI Valencia

Valencia, Valencia, 46015, Spain

Location

MeSH Terms

Conditions

Infertility

Interventions

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

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 25, 2014

First Posted

October 2, 2014

Study Start

September 1, 2014

Primary Completion

July 1, 2015

Study Completion

November 1, 2015

Last Updated

January 18, 2016

Record last verified: 2016-01

Locations

ES(4)