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

Phase 4

Terminated

• Conditions: Patients for In Vitro Fertilization(IVF)Treatment
• Interventions: Drug: recombinant FSH; Drug: HP-HMG

• Registration Number: NCT01345812
• Lead Sponsor: University of Aarhus

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.

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study Start: 2011-04
• Study First Submitted: 2011-04-29
• Study First Submitted QC: 2011-04-29
• Study First Posted: 2011-05-02
• Primary Completion: 2012-07
• Study Completion: 2012-08
• Status Verified: 2012-09
• Last Update Submitted: 2012-09-13
• Last Update Posted: 2012-09-14

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 291

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

Read More

Exclusion Criteria

PCO

• Endometriosis as primary diagnosis

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
recombinant FSH	recombinant FSH	Follicle stimulation hormone
urine-derived FSH	HP-HMG	Follicle stimulating hormone

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

The fertility clinic; 🇩🇰 Braedstrup, Denmark