NCT01345812

Brief Summary

The primary purpose of the investigation is to identify differences in embryo development after follicle stimulation with two different gonadotrophins.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
291

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Apr 2011

Geographic Reach
1 country

1 active site

Status
terminated

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

April 1, 2011

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

April 29, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 2, 2011

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2012

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2012

Completed
Last Updated

September 14, 2012

Status Verified

September 1, 2012

Enrollment Period

1.3 years

First QC Date

April 29, 2011

Last Update Submit

September 13, 2012

Conditions

Patients for In Vitro Fertilization(IVF)Treatment

Keywords

ARTIVFTimelapse

Outcome Measures

Primary Outcomes (1)

  • Number of Top Quality Embryos day 2

    The oocytes are inseminated and loaded to the time-lapse instrument and cultured for two days. The embryo developemnt are followed at the movie and the embryos are scored according to a standard scoring criteria at 44 h after insemination

    44 h after insemination

Secondary Outcomes (1)

  • Implantation rate

    5 weeks after embryo transfer

Study Arms (2)

urine-derived FSH

ACTIVE COMPARATOR

Follicle stimulating hormone

Drug: HP-HMG

recombinant FSH

ACTIVE COMPARATOR

Follicle stimulation hormone

Drug: recombinant FSH

Interventions

HP-HMGDRUG

100 - 300 IU for stimulation of women in ART treatment

Also known as: Menopure
urine-derived FSH
recombinant FSHDRUG

100 -300 IU for stimulation of women in ART treatment

Also known as: Gonal-F
recombinant FSH

Eligibility Criteria

Age21 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Participants(heterosexuals, lesbian couples and single women) must sign a document of informed consent
  • Female age 21-45 years(both inclusive)
  • Patients for IVF treatment
  • Regular menstrual cycle 21-35 days(both inclusive)
  • Normal FSH levels(1-15 IU/L)
  • BMI between 18-32(both inclusive)
  • Patients must be able to read and understand patient information in national language

You may not qualify if:

  • PCO
  • \- Endometriosis as primary diagnosis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The fertility clinic

Brædstrup, 8740, Denmark

Location

Related Links

MeSH Terms

Interventions

follitropin alfa

Study Officials

  • Inge Agerholm, Phd

    IVF clinic Braedstrup

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 29, 2011

First Posted

May 2, 2011

Study Start

April 1, 2011

Primary Completion

July 1, 2012

Study Completion

August 1, 2012

Last Updated

September 14, 2012

Record last verified: 2012-09

Locations

DK(1)