NCT04142190

Brief Summary

The study evaluates the influence of corifollitropin alfa (Elonva) on embryo morphokinetics and fertility treatment outcome in comparison to a control group stimulated with Follitropin beta (Puregon).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,351

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2013

Longer than P75 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2013

Completed
5.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

October 14, 2019

Completed
15 days until next milestone

First Posted

Study publicly available on registry

October 29, 2019

Completed
Last Updated

October 29, 2019

Status Verified

October 1, 2019

Enrollment Period

5.9 years

First QC Date

October 14, 2019

Last Update Submit

October 25, 2019

Conditions

Infertility

Keywords

follicle-stimulating hormoneembryo morphokineticsreproductive medicine

Outcome Measures

Primary Outcomes (10)

  • Time of pronuclei disappearance

    Time of pronuclei disappearance in embryos of patients stimulated with ELONVA versus embryos of patients stimulated with PUREGON

    16-18 hours after fertilization

  • Two discrete cells

    The first observation of two discrete cells in embryos of patients stimulated with ELONVA versus embryos of patients stimulated with PUREGON

    26-28 hours after fertilization

  • Three discrete cells

    The first observation of three discrete cells in embryos of patients stimulated with ELONVA versus embryos of patients stimulated with PUREGON

    28-44 hours after fertilization

  • Four discrete cells

    The first observation of four discrete cells in embryos of patients stimulated with ELONVA versus embryos of patients stimulated with PUREGON

    44-45 hours after fertilization

  • Five discrete cells

    The first observation of five discrete cells in embryos of patients stimulated with ELONVA versus embryos of patients stimulated with PUREGON

    44-68 hours after fertilization

  • Six discrete cells

    The first observation of six discrete cells in embryos of patients stimulated with ELONVA versus embryos of patients stimulated with PUREGON

    44-68 hours after fertilization

  • Seven discrete cells

    The first observation of seven discrete cells in embryos of patients stimulated with ELONVA versus embryos of patients stimulated with PUREGON

    44-68 hours after fertilization

  • Eight discrete cells

    The first observation of eight discrete cells in embryos of patients stimulated with ELONVA versus embryos of patients stimulated with PUREGON

    68-69 hours after fertilization

  • Nine discrete cells

    The first observation of nine discrete cells in embryos of patients stimulated with ELONVA versus embryos of patients stimulated with PUREGON

    69-92 hours after fertilization

  • Morula stage

    End of the compaction process; when observable compaction is complete in embryos of patients stimulated with ELONVA versus embryos of patients stimulated with PUREGON

    92 hours after fertilization

Secondary Outcomes (8)

  • Number of oocytes retrieved

    Number of oocytes retrieved will be evaluated after one treatment cycle (each cycle is between 28 and 35 days)

  • Stage of oocyte development

    Stage of oocytes retrieved will be evaluated after one treatment cycle (each cycle is between 28 and 35 days)

  • Fertilized oocytes

    Number of fertilized oocytes will be evaluated after one treatment cycle (each cycle is between 28 and 35 days)

  • Embryo grading

    The quality of embryos will be evaluated after one treatment cycle (each cycle is between 28 and 35 days)

  • Biochemical pregnancy (measurement of beta hCG)

    Biochemical pregnancies will be evaluated after successful implantation (1 week after embryo transfer)

  • +3 more secondary outcomes

Study Arms (2)

ELONVA

Patients stimulated with Elonva

Drug: ELONVA

PUREGON

Patients stimulated with Puregon

Drug: PUREGON

Interventions

ELONVADRUG

Elonva is a solution for injection that contains the active substance corifollitropin alfa. It is available as a pre-filled syringe (100 and 150 micrograms).Elonva is used in women who are undergoing fertility treatment to stimulate the development of more than one mature egg at a time in the ovaries.

ELONVA
PUREGONDRUG

Puregon contains the active substance follitropin beta. fertilisation). Puregon is administered to stimulate the ovaries to produce more than one egg at a time

PUREGON

Eligibility Criteria

Age18 Years - 42 Years
Sexfemale
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

Women suffering from infertility

You may qualify if:

  • Age: 18-42
  • BMI: 19-29.9
  • Primary or secondary infertility
  • Ovarian stimulation with Elonva/Puregon
  • Embryos cultured in embryoscope

You may not qualify if:

  • unexpected low response
  • genetic testing

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Das Kinderwunsch Institut Schenk GmbH

Dobl, Styria, 8143, Austria

Location

Related Publications (6)

  • Gryshchenko MG, Pravdyuk AI, Parashchyuk VY. Analysis of factors influencing morphokinetic characteristics of embryos in ART cycles. Gynecol Endocrinol. 2014 Oct;30 Suppl 1:6-8. doi: 10.3109/09513590.2014.945763.

    PMID: 25200818BACKGROUND

  • Wissing ML, Bjerge MR, Olesen AI, Hoest T, Mikkelsen AL. Impact of PCOS on early embryo cleavage kinetics. Reprod Biomed Online. 2014 Apr;28(4):508-14. doi: 10.1016/j.rbmo.2013.11.017. Epub 2013 Dec 17.

    PMID: 24581983BACKGROUND

  • Chawla M, Fakih M, Shunnar A, Bayram A, Hellani A, Perumal V, Divakaran J, Budak E. Morphokinetic analysis of cleavage stage embryos and its relationship to aneuploidy in a retrospective time-lapse imaging study. J Assist Reprod Genet. 2015 Jan;32(1):69-75. doi: 10.1007/s10815-014-0372-3. Epub 2014 Nov 14.

    PMID: 25395178BACKGROUND

  • Armstrong S, Vail A, Mastenbroek S, Jordan V, Farquhar C. Time-lapse in the IVF-lab: how should we assess potential benefit? Hum Reprod. 2015 Jan;30(1):3-8. doi: 10.1093/humrep/deu250. Epub 2014 Oct 14.

    PMID: 25316446BACKGROUND

  • Milewski R, Kuc P, Kuczynska A, Stankiewicz B, Lukaszuk K, Kuczynski W. A predictive model for blastocyst formation based on morphokinetic parameters in time-lapse monitoring of embryo development. J Assist Reprod Genet. 2015 Apr;32(4):571-9. doi: 10.1007/s10815-015-0440-3. Epub 2015 Feb 18.

    PMID: 25690157BACKGROUND

  • VerMilyea MD, Tan L, Anthony JT, Conaghan J, Ivani K, Gvakharia M, Boostanfar R, Baker VL, Suraj V, Chen AA, Mainigi M, Coutifaris C, Shen S. Computer-automated time-lapse analysis results correlate with embryo implantation and clinical pregnancy: a blinded, multi-centre study. Reprod Biomed Online. 2014 Dec;29(6):729-36. doi: 10.1016/j.rbmo.2014.09.005. Epub 2014 Sep 21.

    PMID: 25444507BACKGROUND

MeSH Terms

Conditions

Infertility

Interventions

follitropin beta

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Study Officials

  • Michael Schenk, Dr.

    Das Kinderwunsch Institut Schenkg GmbH

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 14, 2019

First Posted

October 29, 2019

Study Start

January 1, 2013

Primary Completion

December 1, 2018

Study Completion

December 1, 2018

Last Updated

October 29, 2019

Record last verified: 2019-10

Locations

AU(1)