Time-lapse Evaluation of Embryo Development After Stimulation With One of Two Different Gonadotrophins.
The primary purpose of the investigation is to identify differences in embryo development after follicle stimulation with two different gonadotrophins.
Patients for In Vitro Fertilization(IVF)Treatment
Drug: recombinant FSH
|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).|
- 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
- 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.
|Study Start Date:||April 2011|
|Study Completion Date:||August 2012|
|Primary Completion Date:||July 2012 (Final data collection date for primary outcome measure)|
Active Comparator: urine-derived FSH
Follicle stimulating hormone
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
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01345812
|The fertility clinic|
|Braedstrup, Denmark, 8740|
|Principal Investigator:||Inge Agerholm, Phd||IVF clinic Braedstrup|