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

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

Status

Terminated

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01345812

Enrollment

291

Registered

2011-05-02

Start date

2011-04-30

Completion date

2012-08-31

Last updated

2012-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients for In Vitro Fertilization(IVF)Treatment

Keywords

ART, IVF, Timelapse

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.

Interventions

DRUGHP-HMG

100 - 300 IU for stimulation of women in ART treatment

DRUGrecombinant FSH

100 -300 IU for stimulation of women in ART treatment

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

21 Years to 45 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Number of Top Quality Embryos day 2	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

Measure	Time frame	Description
Implantation rate	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.

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026