NCT00565747

Brief Summary

This study is to assess whether addition of 2 ng/ml GM-CSF into a specific culture medium will increase the chance of a pregnancy after in vitro fertilisation.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
1,332

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Nov 2007

Typical duration for phase_3

Geographic Reach
2 countries

14 active sites

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

November 1, 2007

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

November 28, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 30, 2007

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2010

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2011

Completed
2.2 years until next milestone

Results Posted

Study results publicly available

November 8, 2013

Completed
Last Updated

May 15, 2015

Status Verified

April 1, 2015

Enrollment Period

3 years

First QC Date

November 28, 2007

Results QC Date

May 7, 2013

Last Update Submit

April 28, 2015

Conditions

Infertility

Keywords

GM-CSFinfertility

Outcome Measures

Primary Outcomes (1)

  • Ongoing Implantation Rate Week 7

    Defined as number of gestational sacs with fetal heart beat, shown by ultrasound in gestational week 7 in percentage of number of embryo transferred.

    Approximately 5 weeks from oocyte pick-up (corresponding to 7 weeks from ovulation)

Secondary Outcomes (2)

  • Number of Top Quality Embryos (TQE´s)

    3 days from oocyte pick-up

  • Live Birth

    Until 7 days after birth

Study Arms (2)

Test culture

EXPERIMENTAL

Culture with GM-CSF

Device: Test culture

Control culture

PLACEBO COMPARATOR

Culture without GM-CSF

Device: Control culture

Interventions

Test cultureDEVICE

A standard culture medium with added GM-CSF (ready-to-use)

Also known as: EmbryoGen
Test culture
Control cultureDEVICE

The same standard culture medium, but without any additions (ready-to-use)

Also known as: EmbryoAssist
Control culture

Eligibility Criteria

Age25 Years - 39 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • The couple or single woman has signed an informed consent form before any trial-related activities.
  • In Vitro Fertilization (IVF) or IntraCytoplasmic Sperm Injection (ICSI) treatment indicated
  • years of age (both inclusive)
  • Regular menstrual cycle: 21-35 days (both inclusive)
  • Women treated with a standard Gonadotropin-Releasing Hormone (GnRH) agonist or antagonist protocol and a Follicle Stimulating Hormone (FSH) / human Menopausal Gonadotropin (hMG) starting dose between 100 and 300 IU daily.
  • human Chorionic Gonadotropin (hCG) administration when the leading follicle has a calculated diameter of minimum 17 mm, or the day after.
  • At least 3 follicles with a calculated diameter of ≥ 14 mm at the day of hCG.

You may not qualify if:

  • The woman has previously participated in the DK001 study.
  • Use of assisted hatching.
  • Indication for Testicular Sperm Aspiration (TESA) or Percutaneous Epididymal Sperm Aspiration (PESA)
  • Any medical conditions or genetic disorders prohibiting IVF/ICSI or interfering with the interpretation of results of the study (including pre-implantation genetic diagnostics).
  • Use of any investigational drug within 30 days before oocyte retrieval
  • Any severe chronic disease of relevance for reproductive function.
  • Oocyte donation patients (donor or recipient).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (14)

Maigaard Fertilitetsklinik

Aarhus, 8200, Denmark

Location

Ciconia Aarhus Privathospital, Fertilitetsklinikken

Aarhus, 8270, Denmark

Location

Brædstrup Sygehus; IVF-Klinikken

Brædstrup, 8740, Denmark

Location

Rigshospitalet, Fertilitetsklinikken afd. 4071

Copenhagen, 2100, Denmark

Location

Fertilitetsklinikken Dronninglund

Dronninglund, 9330, Denmark

Location

IVF-SYD

Fredericia, 7000, Denmark

Location

Herlev Hospital, Fertilitetsklinikken G114F

Herlev, 2730, Denmark

Location

Holbæk Sygehus, Fertilitetsklinikken

Holbæk, 4300, Denmark

Location

Hvidovre Hospital; Fertilitetsklinikken afd. 455

Hvidovre, 2650, Denmark

Location

Odense Universitets Hospital, Fertilitetsklinikken

Odense, 5000, Denmark

Location

Regionshospitalet Skive, Fertilitetsklinikken

Skive, 7800, Denmark

Location

IVF Kliniken Öresund

Malmo, 205 12, Sweden

Location

Karolinska Universitetssjukhuset Huddinge, Fertilitetsenheten K59

Stockholm, 14186, Sweden

Location

Reproduktionscentrum

Uppsala, 751 85, Sweden

Location

Related Publications (2)

  • Rodriguez-Wallberg KA, Munding B, Ziebe S, Robertson SA. GM-CSF does not rescue poor-quality embryos: secondary analysis of a randomized controlled trial. Arch Gynecol Obstet. 2020 May;301(5):1341-1346. doi: 10.1007/s00404-020-05532-3. Epub 2020 Apr 9.

    PMID: 32274634DERIVED

  • Ziebe S, Loft A, Povlsen BB, Erb K, Agerholm I, Aasted M, Gabrielsen A, Hnida C, Zobel DP, Munding B, Bendz SH, Robertson SA. A randomized clinical trial to evaluate the effect of granulocyte-macrophage colony-stimulating factor (GM-CSF) in embryo culture medium for in vitro fertilization. Fertil Steril. 2013 May;99(6):1600-9. doi: 10.1016/j.fertnstert.2012.12.043. Epub 2013 Feb 4.

    PMID: 23380186DERIVED

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Results Point of Contact

Title
Chief Scientific Officer
Organization
Origio A/S
sbendz@origio.com
+45 46790200

Study Officials

  • Søren Ziebe, M.Sc.

    Rigshospitalet, Fertilitetsklinikken afd. 4071

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 28, 2007

First Posted

November 30, 2007

Study Start

November 1, 2007

Primary Completion

November 1, 2010

Study Completion

September 1, 2011

Last Updated

May 15, 2015

Results First Posted

November 8, 2013

Record last verified: 2015-04

Locations

DK(11)SE(3)