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

Study Overview
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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.

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

Conditions
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Patients for In Vitro Fertilization(IVF)Treatment

Intervention / Treatment
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* Drug: HP-HMG
* Drug: recombinant FSH


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: urine-derived FSH<br>Follicle stimulating hormone | Drug: HP-HMG<br>* 100 - 300 IU for stimulation of women in ART treatment<br>* Other names: Menopure;|
| Active Comparator: recombinant FSH<br>Follicle stimulation hormone | Drug: recombinant FSH<br>* 100 -300 IU for stimulation of women in ART treatment<br>* Other names: Gonal-F;|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ART, IVF, Timelapse