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

Patients for In Vitro Fertilization(IVF)Treatment Clinical Trial

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).

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01345812
• Other study ID #: 20090169
• Status: Terminated
• Phase: Phase 4
• First received: April 29, 2011
• Last updated: September 13, 2012
• Start date: April 2011
• Est. completion date: August 2012

Study information

• Verified date: September 2012
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Ethics CommitteeDenmark: Danish Dataprotection Agency
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 291
• Est. completion date: August 2012
• Est. primary completion date: July 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years to 45 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Patients for In Vitro Fertilization(IVF)Treatment

Intervention

Drug:
• HP-HMG
100 - 300 IU for stimulation of women in ART treatment
• recombinant FSH
100 -300 IU for stimulation of women in ART treatment

Locations

Country	Name	City	State
Denmark	The fertility clinic	Braedstrup

Sponsors (7)

Lead Sponsor	Collaborator
University of Aarhus	Aagaard Fertility Clinic, Ferring Pharmaceuticals, Herlev Hospital, Odense University Hospital, The Fertility Clinic Braedstrup Hospital, Trianglen Fertility Clinic

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Implantation rate	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	No

External Links

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