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

University of Aarhus logo

University of Aarhus

Status and phase

Terminated
Phase 4

Conditions

Patients for In Vitro Fertilization(IVF)Treatment

Treatments

Drug: recombinant FSH
Drug: HP-HMG

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT01345812
20090169

Details and patient eligibility

About

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

Full 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.

Enrollment

291 patients

Sex

All

Ages

21 to 45 years old

Volunteers

No 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

291 participants in 2 patient groups

urine-derived FSH
Active Comparator group
Description:
Follicle stimulating hormone
Treatment:
Drug: HP-HMG
recombinant FSH
Active Comparator group
Description:
Follicle stimulation hormone
Treatment:
Drug: recombinant FSH

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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