Time-lapse Evaluation of Embryo Development After Stimulation With One of Two Different Gonadotrophins.

September 13, 2012 updated by: University of Aarhus

Time-lapse Assessed Evaluation of Embryo Development After Stimulation With Either Recombinant Follicle Stimulating Hormone (FSH) or Urine-derived Follicle Stimulating Hormone (FSH).

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

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

So far the assessment of the development potential of the single embryo has been limited by the vulnerability of the embryos when exposed to fluctuations in temperature and CO2 levels.

Thus embryos can only be allowed to leave incubators for a very limited time period.

However, with the development of time-lapse systems for clinical use it is possible to make continuous time-lapse recordings of embryos while they are in a safe incubator environment.

The embryos are not compromised, but the entire embryonic development can still be seen, and will subsequently provide new and essential information on the competence of the single embryo.

Based on the above it is expected that the probability of selecting the most viable and competent embryo is increased, which, in turn, will increase the success rate for couples seeking infertility treatment.

Study Type

Interventional

Enrollment (Actual)

291

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Braedstrup, Denmark, 8740
        • The fertility clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 45 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

PCO

- Endometriosis as primary diagnosis

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: urine-derived FSH
Follicle stimulating hormone
Drug: HP-HMG
100 - 300 IU for stimulation of women in ART treatment
Other Names:
  • Menopure
ACTIVE_COMPARATOR: recombinant FSH
Follicle stimulation hormone
Drug: recombinant FSH
100 -300 IU for stimulation of women in ART treatment
Other Names:
  • Gonal-F

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Top Quality Embryos day 2
Time Frame: 44 h after insemination
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Implantation rate
Time Frame: 5 weeks after embryo transfer
The pregnancy is verified by a blood sample two weeks after embryo transfer and the number of embryos implanted are verified by ultrasound scanning five weeks after embryo transfer.
5 weeks after embryo transfer

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Aarhus

Collaborators

Odense University Hospital
Ferring Pharmaceuticals
Herlev Hospital
The Fertility Clinic Braedstrup Hospital
Trianglen Fertility Clinic
Aagaard Fertility Clinic

Investigators

  • Principal Investigator: Inge Agerholm, Phd, IVF clinic Braedstrup

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2011

Primary Completion (ACTUAL)

July 1, 2012

Study Completion (ACTUAL)

August 1, 2012

Study Registration Dates

First Submitted

April 29, 2011

First Submitted That Met QC Criteria

April 29, 2011

First Posted (ESTIMATE)

May 2, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

September 14, 2012

Last Update Submitted That Met QC Criteria

September 13, 2012

Last Verified

September 1, 2012

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 20090169

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe