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Effect of Intrauterine Administration of Autologous PBMC Modulated With IFNt on IVF Outcome

Primary Purpose

Infertility, Female, IVF

Status
Recruiting
Phase
Not Applicable
Locations
Bulgaria
Study Type
Interventional
Intervention
PBMC immunomodulated with IFNt
Sponsored by
Nadezhda Women's Health Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Infertility, Female focused on measuring intrauterine PBMC, interferon tau, implantation, clinical pregnancy, live birth rate

Eligibility Criteria

18 Years - 50 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria: Participating in Assisted Reproduction Treatment Having primary infertility Having regular menstrual cycles Scheduled to undergo embryo transfer of euploid embryos only 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

Sites / Locations

  • Nadezhda Women's Health HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intrauterine administration of PBMC immunomodulated with IFNt

Control Group

Arm Description

Approximately 9 ml whole blood will be collected from each patient 5 days post LH peak by peripheral venipuncture using a 21G butterfly catheter affixed via vacutainer to negative pressure receiving tubes (BD vacutainer acid-citrate-dextrose (ACD-A), REF:366645). PBMC will be isolated by density gradient centrifugation in room-temperature centrifuge set to 400 g for 25 min. After washing the obtained PBMCs, they will be suspended in RPMI 1640 supplemented with 10% HSA (human serum albumin) and incubated in the presence of 500 IU/ml IFNt for 24 h at 37˚C. On day 6 after LH peak, this cultured cell suspension will be carefully introduced in the uterine cavity by catheter. The following day (LH+7), patients will undergo a standard embryo transfer (ET) procedure.

Participants will undergo standard embryo transfer procedure with no intervention.

Outcomes

Primary Outcome Measures

Rate of Implantation, %
Percentage of patients with positive hCG (human chorionic gonadotropin) test following ET
Clinical Pregnancy Rate, %
Percentage of patients with ultrasound confirmation of gestational sac or heartbeat following ET
Live Birth Rate, %
Percentage of patients with live birth following ET

Secondary Outcome Measures

Full Information

First Posted
March 7, 2023
Last Updated
March 7, 2023
Sponsor
Nadezhda Women's Health Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05775198
Brief Title
Effect of Intrauterine Administration of Autologous PBMC Modulated With IFNt on IVF Outcome
Official Title
Effects of Intrauterine Administration of Autologous Peripheral Blood Mononuclear Cells (PBMC) Immunomodulated With Interferon Tau (IFNt) Prior to Embryo Transfer on IVF Outcome
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 13, 2023 (Anticipated)
Primary Completion Date
March 13, 2026 (Anticipated)
Study Completion Date
April 28, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Nadezhda Women's Health Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The goal of this clinical trial is to test the effect of modulated specialised immune cells isolated from the patients' own blood when administered to the uterus before embryo transfer on the IVF outcome (implantation, pregnancy and live birth rates). To achieve this, blood will be obtained from eligible participants. Target cells will be isolated and incubated with the tested modulator for 24h, and returned to the uterine cavity 1 day prior to embryo transfer. Researchers will compare the reproductive outcome of the tested intervention to that of a control group who will not receive the investigated cell treatment prior to embryo transfer.
Detailed Description
Female patients with no known uterine pathologies scheduled to undergo embryo transfer will be identified through patient records and invited to participate in the study. Five days after luteinizing hormone (LH) surge, peripheral blood mononuclear cells (PBMC) will be isolated from these patients' peripheral blood by density gradient centrifugation and suspended in culture medium. The obtained PBMC will be incubated with 500 IU/ml IFNt at 37˚C for 24 hours. This cell suspension will be carefully introduced in the uterine cavity by catheter on day 6 post LH surge. Embryo transfer will be performed the following day. A suitable age-matched control group will be recruited that will undergo embryo transfer but will not be administered immunomodulated PBMC prior to the transfer. Reproductive outcomes in terms of rate of implantation, rate of clinical pregnancy and live birth rates will be recorded and compared between the two groups. Data analysis will be performed by investigators blind to the patient group.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility, Female, IVF
Keywords
intrauterine PBMC, interferon tau, implantation, clinical pregnancy, live birth rate

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Masking Description
Data analysis will be performed by investigators blind to the patient group.
Allocation
Randomized
Enrollment
300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intrauterine administration of PBMC immunomodulated with IFNt
Arm Type
Experimental
Arm Description
Approximately 9 ml whole blood will be collected from each patient 5 days post LH peak by peripheral venipuncture using a 21G butterfly catheter affixed via vacutainer to negative pressure receiving tubes (BD vacutainer acid-citrate-dextrose (ACD-A), REF:366645). PBMC will be isolated by density gradient centrifugation in room-temperature centrifuge set to 400 g for 25 min. After washing the obtained PBMCs, they will be suspended in RPMI 1640 supplemented with 10% HSA (human serum albumin) and incubated in the presence of 500 IU/ml IFNt for 24 h at 37˚C. On day 6 after LH peak, this cultured cell suspension will be carefully introduced in the uterine cavity by catheter. The following day (LH+7), patients will undergo a standard embryo transfer (ET) procedure.
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
Participants will undergo standard embryo transfer procedure with no intervention.
Intervention Type
Biological
Intervention Name(s)
PBMC immunomodulated with IFNt
Intervention Description
Autologous peripheral blood mononuclear cells (PBMC) isolated using a standard protocol will be cultured in the presence of interferon tau (IFNt) for 24 hours at 37 ˚C and administered in the uterine cavity of patients 1 day prior to embryo transfer.
Primary Outcome Measure Information:
Title
Rate of Implantation, %
Description
Percentage of patients with positive hCG (human chorionic gonadotropin) test following ET
Time Frame
4 to 6 weeks post ET procedure
Title
Clinical Pregnancy Rate, %
Description
Percentage of patients with ultrasound confirmation of gestational sac or heartbeat following ET
Time Frame
6 weeks post ET procedure
Title
Live Birth Rate, %
Description
Percentage of patients with live birth following ET
Time Frame
up to 10 months post ET procedure

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Participating in Assisted Reproduction Treatment Having primary infertility Having regular menstrual cycles Scheduled to undergo embryo transfer of euploid embryos only 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dimitar Parvanov, PhD
Phone
885944618
Ext
359
Email
dimparvanov@abv.bg
Facility Information:
Facility Name
Nadezhda Women's Health Hospital
City
Sofia
ZIP/Postal Code
1330
Country
Bulgaria
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Georgi Stamenov, MD
Phone
888269839
Ext
359
Email
g.stamenov@abv.bg
First Name & Middle Initial & Last Name & Degree
Margarita Ruseva, MSc
Phone
889150267
Ext
359
Email
margarita.ruseva@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No

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Effect of Intrauterine Administration of Autologous PBMC Modulated With IFNt on IVF Outcome

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