Intralipid treatment and infertility
Phase 1
- Conditions
- Infertility conditions that required IVF treatment Male infertility Endometrosis PCOS uNEXPLAINED INFERTILITY Tubal damageTherapeutic area: Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13]
- Registration Number
- EUCTR2017-002936-17-SE
- Lead Sponsor
- ivio Falun
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- Not specified
- Target Recruitment
- 2200
Inclusion Criteria
Inclusion -Eligible for IVF tratment .Max female age 39years ,AMH=>1
NG/ML, BMI<35, Ejaculated Viable Spermatozoa.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 2200
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 0
Exclusion Criteria
Myoma-Firoids ,uterine anomlies,Allergies against soya,peanuts,glycin
and eggs.
diseases requiring medications such as diabetes,Female age öve r39
years .
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br> Main Objective: The overall goal of the study is to resarch the benfit of modulating the<br> immune response using intravenously adminsterad intralipid for clinets<br> during the first IVF cycle<br> ;Secondary Objective: no;Primary end point(s): Positive Preganancy test;Timepoint(s) of evaluation of this end point: 4-5 weeks of pregnancy
- Secondary Outcome Measures
Name Time Method Secondary end point(s): Ultrasound verifed pregnancy;Timepoint(s) of evaluation of this end point: 7-8 weeks of pregnancy