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Clinical Trials/NCT01345812
NCT01345812
Terminated
Phase 4

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

University of Aarhus1 site in 1 country291 target enrollmentApril 2011

Overview

Phase
Phase 4
Intervention
HP-HMG
Conditions
Patients for In Vitro Fertilization(IVF)Treatment
Sponsor
University of Aarhus
Enrollment
291
Locations
1
Primary Endpoint
Number of Top Quality Embryos day 2
Status
Terminated
Last Updated
13 years ago

Overview

Brief Summary

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

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.

Registry
clinicaltrials.gov
Start Date
April 2011
End Date
August 2012
Last Updated
13 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility 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

  • Endometriosis as primary diagnosis

Arms & Interventions

urine-derived FSH

Follicle stimulating hormone

Intervention: HP-HMG

recombinant FSH

Follicle stimulation hormone

Intervention: recombinant FSH

Outcomes

Primary Outcomes

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

Secondary Outcomes

  • Implantation rate(5 weeks after embryo transfer)

Study Sites (1)

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