NCT02018159

Brief Summary

This post-marketing, multi-center prospective study will be conducted in a open-label, non-interventional setting, for women seeking fertility treatment and will describe morphokinetic de-selection parameters in human embryos.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
738

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2014

Typical duration for all trials

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 17, 2013

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 23, 2013

Completed
9 days until next milestone

Study Start

First participant enrolled

January 1, 2014

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 12, 2016

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 12, 2016

Completed
Last Updated

August 28, 2017

Status Verified

August 1, 2017

Enrollment Period

2.1 years

First QC Date

December 17, 2013

Last Update Submit

August 25, 2017

Conditions

Infertility

Outcome Measures

Primary Outcomes (4)

  • Incidence of direct cleavage from 1 to 3 and from 2 to 5 cells

    1 week after oocyte retrieval

  • Incidence of uneven blastomeres at the 2 and 4 cell stage

    1 week after oocyte retrieval

  • Incidence of bi- and multinucleation at 2 cell and 4 cell stage

    1 week after oocyte retrieval

  • Incidence of Smooth Endoplasmatic Reticulum at the Metaphase II stage, the Pro Nuclei stage and the 2, 3 and 4 cell stage

    1 week after oocyte retrieval

Secondary Outcomes (5)

  • Positive serum human Chorion Gonadotrophin (hCG) rate

    13-15 days after transfer

  • Implantation rate

    5 weeks after transfer

  • Clinical pregnancy rate

    7 weeks after transfer

  • Ongoing pregnancy rate

    10 weeks after transfer

  • Live birth rate

    9 months

Study Arms (1)

Women treated with Menopur

Women treated with Menopur can participate with more than one cycle. 700 cycles will be enrolled.

Drug: menotropin

Interventions

menotropinDRUG
Also known as: Menopur
Women treated with Menopur

Eligibility Criteria

Age21 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Women seeking fertility treatment

You may qualify if:

  • Age 21-45 years
  • In Vitro Fertilisation/Intra Cytoplasmic Sperm Injection treatment in long or short protocol
  • Receiving follicle stimulation with Menopur 600/1200 IU

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fertilitetsklinikken Hospitalsenheden Horsens, Regionshospitalet Horsens (there may be other sites in this country)

Horsens, Denmark

Location

MeSH Terms

Conditions

Infertility

Interventions

Menotropins

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

  • Clinical Development Support

    Ferring Pharmaceuticals

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 17, 2013

First Posted

December 23, 2013

Study Start

January 1, 2014

Primary Completion

February 12, 2016

Study Completion

May 12, 2016

Last Updated

August 28, 2017

Record last verified: 2017-08

Locations

DK(1)