Comparison of the Effect of Lymphotherapy and Prednisolone Therapy on the Change in the Population of Natural Killer T Cells in Women with Recurrent Spontaneous Abortion

Comparison of the Effect of Lymphotherapy and Prednisolone Therapy on Subpopulation and Phenotype Change of Natural Killer Cells (NK) and NKT Cells in Women with Recurrent Spontaneous Abortion (RSA)

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20210115050041N2

Enrollment

Registered

2021-02-22

Start date

2021-04-21

Completion date

Unknown

Last updated

2021-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Recurrent Spontaneous Abortion. Spontaneous abortion

Interventions

Intervention 1: Intervention group: Oral administration of prednisolone tablets (Iran Hormone Pharmaceutical Co) for 2 months at a dose of 5 mg per day. Intervention 2: Intervention group:Treatment th

the lymphocytes are isolated and inactivated. Then they are injected subcutaneously into the woman's arms as a sterile cell suspension. These injections are repeated 3 times at 3-4 week intervals. Thi

Eligibility

Sex/Gender

Female

Age

20 Years to 35 Years

Inclusion criteria

Inclusion criteria: En Females in the age of 20 to 35 years Natural fertility History of two or more spontaneous abortions before 12 weeks of gestation APCA (anti-paternal cytotoxic antibody) titer less than 10%

Exclusion criteria

Exclusion criteria: Pregnancy Smoking and alcohol consumption BMI more than 30 kg / m² Certain autoimmune diseases such as SLE and APA Acute infection with TORCH agents including Toxoplasma, HCV, Rubella, CMV and HSV Previous treatment with corticosteroids and immunotherapy

Design outcomes

Primary

Measure	Time frame
Percentage of sub-population of NKT cells. Timepoint: Pre-intervention (beginning of treatment), post intervention (finished treatment); 2 months interval. Method of measurement: Cell's percentage by means of Flow cytometry technique.;Percentage of NK CD56 Bright cells. Timepoint: Pre-intervention (beginning of treatment), post intervention (finished treatment); 2 months interval. Method of measurement: cell's percentage by means of Flow cytometry technique.;Serum levels of IL-10. Timepoint: Pre-intervention (beginning of treatment), post intervention (finished treatment); 2 months interval. Method of measurement: Serum concentration of soluble cytokines through ELISA (enzyme-linked immunoassay) technique.;Serum levels of TGF-ß. Timepoint: Pre-intervention (beginning of treatment), post intervention (finished treatment); 2 months interval. Method of measurement: Serum concentration of soluble cytokines through ELISA (enzyme-linked immunoassay) technique.;Serum levels of GM-CSF. Timepoint: Pre-intervention (beginning of treatment), post intervention (finished treatment); 2 months interval. Method of measurement: Serum concentration of soluble cytokines through ELISA (enzyme-linked immunoassay) technique.	—

Measure

Time frame

Percentage of sub-population of NKT cells. Timepoint: Pre-intervention (beginning of treatment), post intervention (finished treatment); 2 months interval. Method of measurement: Cell's percentage by means of Flow cytometry technique.;Percentage of NK CD56 Bright cells. Timepoint: Pre-intervention (beginning of treatment), post intervention (finished treatment); 2 months interval. Method of measurement: cell's percentage by means of Flow cytometry technique.;Serum levels of IL-10. Timepoint: Pre-intervention (beginning of treatment), post intervention (finished treatment); 2 months interval. Method of measurement: Serum concentration of soluble cytokines through ELISA (enzyme-linked immunoassay) technique.;Serum levels of TGF-ß. Timepoint: Pre-intervention (beginning of treatment), post intervention (finished treatment); 2 months interval. Method of measurement: Serum concentration of soluble cytokines through ELISA (enzyme-linked immunoassay) technique.;Serum levels of GM-CSF. Timepoint: Pre-intervention (beginning of treatment), post intervention (finished treatment); 2 months interval. Method of measurement: Serum concentration of soluble cytokines through ELISA (enzyme-linked immunoassay) technique.

—

Secondary

Measure	Time frame
Decreasing the number of abortions. Timepoint: After trying to conceive; 2-6 months after the end of treatment. Method of measurement: questionnaire completion.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactFatemeh Rezayat

Esfahan University of Medical Sciences

fatemeh.rzt@resident.mui.ac.ir+98 31 3779 0480

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026