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

This study has been terminated.
(Lack of patients for recruitment)
Sponsor:
Collaborators:
The Fertility Clinic Braedstrup Hospital
Herlev Hospital
Odense University Hospital
Trianglen Fertility Clinic
Aagaard Fertility Clinic
Ferring Pharmaceuticals
Information provided by (Responsible Party):
University of Aarhus
ClinicalTrials.gov Identifier:
NCT01345812
First received: April 29, 2011
Last updated: September 13, 2012
Last verified: September 2012
  Purpose

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


Condition Intervention Phase
Patients for In Vitro Fertilization(IVF)Treatment
Drug: HP-HMG
Drug: recombinant FSH
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Time-lapse Assessed Evaluation of Embryo Development After Stimulation With Either Recombinant Follicle Stimulating Hormone (FSH) or Urine-derived Follicle Stimulating Hormone (FSH).

Resource links provided by NLM:


Further study details as provided by University of Aarhus:

Primary Outcome Measures:
  • Number of Top Quality Embryos day 2 [ Time Frame: 44 h after insemination ] [ Designated as safety issue: No ]
    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


Secondary Outcome Measures:
  • Implantation rate [ Time Frame: 5 weeks after embryo transfer ] [ Designated as safety issue: No ]
    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.


Enrollment: 291
Study Start Date: April 2011
Study Completion Date: August 2012
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: urine-derived FSH
Follicle stimulating hormone
Drug: HP-HMG
100 - 300 IU for stimulation of women in ART treatment
Other Name: Menopure
Active Comparator: recombinant FSH
Follicle stimulation hormone
Drug: recombinant FSH
100 -300 IU for stimulation of women in ART treatment
Other Name: Gonal-F

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.

  Eligibility

Ages Eligible for Study:   21 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01345812

Locations
Denmark
The fertility clinic
Braedstrup, Denmark, 8740
Sponsors and Collaborators
University of Aarhus
The Fertility Clinic Braedstrup Hospital
Herlev Hospital
Odense University Hospital
Trianglen Fertility Clinic
Aagaard Fertility Clinic
Ferring Pharmaceuticals
Investigators
Principal Investigator: Inge Agerholm, Phd IVF clinic Braedstrup
  More Information

Additional Information:
No publications provided

Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT01345812     History of Changes
Other Study ID Numbers: 20090169
Study First Received: April 29, 2011
Last Updated: September 13, 2012
Health Authority: Denmark: Ethics Committee
Denmark: Danish Dataprotection Agency

Keywords provided by University of Aarhus:
ART
IVF
Timelapse

Additional relevant MeSH terms:
Follicle Stimulating Hormone
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on November 27, 2014