Effects of Intrauterine Administration of Autologous PBMC Modulated With IFNt on Endometrial Cell Populations
Launched by NADEZHDA WOMEN'S HEALTH HOSPITAL · Mar 7, 2023
Trial Information
Current as of July 25, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is looking at how a specific treatment might improve the chances of pregnancy for women experiencing infertility. The treatment involves giving patients a special type of immune cells from their own body, which are modified in the lab, directly into the uterus. Researchers want to see how this treatment affects the inner lining of the uterus (called the endometrium) during the critical time when an embryo would implant. To do this, they will take small samples of the endometrium from participants before and after the treatment to study any changes.
Women who are between 18 and 62 years old, have regular menstrual cycles, and are undergoing assisted reproductive treatments may be eligible to join the study. Participants will need to provide consent and will have two small biopsies taken during their menstrual cycles. It’s important to note that women with certain health issues, like specific infections or autoimmune conditions, will not be able to participate. This trial is currently recruiting, and it offers an opportunity for women seeking help with infertility to potentially benefit from a new treatment approach.
Gender
FEMALE
Eligibility criteria
- Inclusion Criteria:
- • Participating in Assisted Reproduction Treatment
- • Having primary infertility
- • Having regular menstrual cycles
- • Having signed informed consent
- Exclusion Criteria:
- • Uterine pathologies
- • Endometrial bacterial infections
- • Active endometrial inflammation
- • Polycystic ovary syndrome
- • Presence of auto antibodies such as anti-TPO (thyroid peroxidase), anti-TG (thyroglobulin), ACA (anticentromere antibodies), APA (antiphospholipid antibodies), ANA (antinuclear antibodies), and anti-dsDNA
- • Presence of mutations involving the coagulation system such as deficiency of factor XII, Pro C, Pro S
- • Oncological condition
- • Positive HIV (human immunodeficiency virus), HCV (hepatitis C virus) or HBV (hepatitis B virus) tests
About Nadezhda Women's Health Hospital
Nadezhda Women's Health Hospital is a leading healthcare institution dedicated to advancing women's health through innovative clinical research and comprehensive patient care. With a focus on evidence-based practices, the hospital conducts a range of clinical trials aimed at improving treatment outcomes and enhancing the quality of life for women. Employing a multidisciplinary approach, Nadezhda Women's Health Hospital collaborates with experienced researchers and healthcare professionals to ensure the highest standards of safety, efficacy, and ethical considerations in all its studies. Committed to fostering a supportive environment, the hospital prioritizes patient-centered care while contributing to the broader medical community's understanding of women's health issues.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Sofia, , Bulgaria
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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