Study Results
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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ACTIVE_NOT_RECRUITING
22 participants
OBSERVATIONAL
2019-02-18
2023-12-31
Brief Summary
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The collected endometrial tissue and blood samples will be examined for the cytokines profiling using commercially available ELISA kits.
The sample size was calculated choosing, as primary outcome, changes in endometrial LIF concentration between the disease and control Group, which is our main goal. Given a type I error of 5%, a maximum of 21 women are needed for each Group to reach the desired power of 80% to detect the least changes in concentrations.
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Detailed Description
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Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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Study group
Infertile women with autoimmune disease
Measure endometrial markers
Endometrial biopsies will be taken from participants in both groups
Control group
Women from couples with severe male infertility
Measure endometrial markers
Endometrial biopsies will be taken from participants in both groups
Interventions
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Measure endometrial markers
Endometrial biopsies will be taken from participants in both groups
Eligibility Criteria
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Inclusion Criteria
\* Females with infertility combined with autoimmune disease and in fertility treatment.
Control group:
\* Female from couples with severe male infertility and in fertility treatment.
Exclusion Criteria
* Abnormal follicle stimulating hormone (FSH),
* Abnormal antral follicles Count
* Genital infections
* Endometriosis
* Tubal occlusion
* Polycystic ovarian syndrome
18 Years
45 Years
FEMALE
No
Sponsors
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Odense University Hospital
OTHER
Responsible Party
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Jens Fedder
Professor, MD, PhD
Locations
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Centre of Andrology & Fertility Clinic, Department D, Odense University Hospital
Odense, , Denmark
Countries
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Other Identifiers
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Lab.Reprod.Biol. - Odense.04
Identifier Type: -
Identifier Source: org_study_id
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