The Role of Uterine NK Cells and T Cell Cytokines in Recurrent Miscarriage

Study Overview
=================
Brief Summary
-----------------
The aim of the study is to evaluate the role of uterine natural killer cell(uNK)in recurrent pregnancy losses and the correlation between the numbers of it and embryo toxicity by measuring the level of the Th2 cytokines in normal reproductive profile and in patients with Recurrent Pregnancy Losses (RPL).

Detailed Description
-----------------
Office hysteroscopy examination of the patients at the luteal phase of the natural cycle (day17 to day 20),with endometrial biopsy using pipple curette from the region of the fundus, the biopsy sent to flow cytometry laboratory in South Egypt Cancer Institute to be examined for: 1.1. Phenotypic analysis of uterine natural killer cells: 1.2. Induction and detection of intracellular cytokines by flow Cytometry:

Official Title
-----------------
The Role of Uterine NK Cells and T Cell Cytokines in Recurrent Miscarriage.

Conditions
-----------------
Recurrent Pregnancy Losses

Intervention / Treatment
-----------------
* Device: office hysteroscopy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women with unexplained recurrent miscarriages (2 or more consecutive). All patients have normal uterine cavity diagnosed by HSG and /or hysteroscopy, normal semen analysis, normal thrombophilic profiles, no history of malformed normal fetus in the previous miscarriages Exclusion Criteria: Age above forty years old . Antiphospholipid syndrome (lupus anticoagulant and/or anticardiolipin antibodies [IgG or IgM]); other recognised thrombophilic conditions (testing according to usual clinic practice). Intrauterine abnormalities (as assessed by ultrasound, hysterosonography, hysterosalpingogram, or hysteroscopy). Fibroids distorting uterine cavity . Abnormal parental karyotype . Other identifiable causes of recurrent miscarriages (tests initiated only if clinically indicated) e.g., diabetes, thyroid disease and systemic lupus erythematosus (SLE).

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Screening
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: No treatment<br>patients with recurrent miscarriages | Device: office hysteroscopy<br>* Endometrial wash and biopsy is taken at the day around implantation window (day 14_to day 22)of the menstrual cycle from patients of recurrent miscarriages to evaluate the levels of uterine natural killer cells compared to control of females of normal reproductive outcome<br>|
| Active Comparator: OFFICE HYSTEROSCOPY<br>Office hysteroscopic endometrial biopsy at the luteal phase of the menestrual cycle | Device: office hysteroscopy<br>* Endometrial wash and biopsy is taken at the day around implantation window (day 14_to day 22)of the menstrual cycle from patients of recurrent miscarriages to evaluate the levels of uterine natural killer cells compared to control of females of normal reproductive outcome<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the role of uterine natural killer cell(uNK)in recurrent pregnancy losses and the correlation between the numbers of it and embryo toxicity by measuring the level of the Th2 cytokines in normal reproductive profile and in patients with RPL. |  | two years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| to set in the horizon the role of immunomodulators as a treatment for RPL and implantation failure |  | two years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
uterine natural killer cells, recurrent miscarriages, alloimmunity