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

NCT ID: NCT01345812

Last Updated: 2012-09-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

291 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-04-30

Study Completion Date

2012-08-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Patients for In Vitro Fertilization(IVF)Treatment

Keywords

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ART IVF Timelapse

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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urine-derived FSH

Follicle stimulating hormone

Group Type ACTIVE_COMPARATOR

HP-HMG

Intervention Type DRUG

100 - 300 IU for stimulation of women in ART treatment

recombinant FSH

Follicle stimulation hormone

Group Type ACTIVE_COMPARATOR

recombinant FSH

Intervention Type DRUG

100 -300 IU for stimulation of women in ART treatment

Interventions

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HP-HMG

100 - 300 IU for stimulation of women in ART treatment

Intervention Type DRUG

recombinant FSH

100 -300 IU for stimulation of women in ART treatment

Intervention Type DRUG

Other Intervention Names

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Menopure Gonal-F

Eligibility Criteria

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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
Minimum Eligible Age

21 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Fertility Clinic Braedstrup Hospital

UNKNOWN

Sponsor Role collaborator

Herlev Hospital

OTHER

Sponsor Role collaborator

Odense University Hospital

OTHER

Sponsor Role collaborator

Trianglen Fertility Clinic

UNKNOWN

Sponsor Role collaborator

Aagaard Fertility Clinic

OTHER

Sponsor Role collaborator

Ferring Pharmaceuticals

INDUSTRY

Sponsor Role collaborator

University of Aarhus

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Inge Agerholm, Phd

Role: PRINCIPAL_INVESTIGATOR

IVF clinic Braedstrup

Locations

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The fertility clinic

Brædstrup, , Denmark

Site Status

Countries

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Denmark

Related Links

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http://www.ncbi.nlm.nih.gov/pubmed/

database

Other Identifiers

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20090169

Identifier Type: -

Identifier Source: org_study_id