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).

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

Study Overview

• Status: Terminated
• Conditions: Patients for In Vitro Fertilization(IVF)Treatment
• Intervention / Treatment: Drug: HP-HMG; Drug: recombinant FSH

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.

• Study Type: Interventional
• Enrollment (Actual): 291
• Phase: Phase 4

Contacts and Locations

Study Locations

• Denmark
  • Braedstrup, Denmark, 8740
    • The fertility clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 45 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: urine-derived FSH; Follicle stimulating hormone	Drug: HP-HMG; 100 - 300 IU for stimulation of women in ART treatment; Other Names: Menopure
ACTIVE_COMPARATOR: recombinant FSH; Follicle stimulation hormone	Drug: recombinant FSH; 100 -300 IU for stimulation of women in ART treatment; Other Names: Gonal-F

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University of Aarhus
• Collaborators: Odense University Hospital; Ferring Pharmaceuticals; Herlev Hospital; The Fertility Clinic Braedstrup Hospital; Trianglen Fertility Clinic; Aagaard Fertility Clinic
• Investigators: Principal Investigator: Inge Agerholm, Phd, IVF clinic Braedstrup

Publications and helpful links

Helpful Links

• database

Study record dates

Study Major Dates

• Study Start: April 1, 2011
• Primary Completion (ACTUAL): July 1, 2012
• Study Completion (ACTUAL): August 1, 2012

Study Registration Dates

• First Submitted: April 29, 2011
• First Submitted That Met QC Criteria: April 29, 2011
• First Posted (ESTIMATE): May 2, 2011

Study Record Updates

• Last Update Posted (ESTIMATE): September 14, 2012
• Last Update Submitted That Met QC Criteria: September 13, 2012
• Last Verified: September 1, 2012

More Information

Terms related to this study

• Keywords: IVF; ART; Timelapse
• Other Study ID Numbers: 20090169