Back to resultsThe Role of Uterine NK Cells and T Cell Cytokines in Recurrent Miscarriage
Primary Purpose
Recurrent Pregnancy Losses
Status
Terminated
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
office hysteroscopy
Sponsored by
About this trial
This is an interventional screening trial for Recurrent Pregnancy Losses focused on measuring uterine natural killer cells, recurrent miscarriages, alloimmunity
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).
Sites / Locations
- Women Health Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
No treatment
OFFICE HYSTEROSCOPY
Arm Description
patients with recurrent miscarriages
Office hysteroscopic endometrial biopsy at the luteal phase of the menestrual cycle
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
to set in the horizon the role of immunomodulators as a treatment for RPL and implantation failure
Full Information
NCT ID
NCT01688284
First Posted
August 6, 2012
Last Updated
January 6, 2021
Sponsor
Woman's Health University Hospital, Egypt
1. Study Identification
Unique Protocol Identification Number
NCT01688284
Brief Title
The Role of Uterine NK Cells and T Cell Cytokines in Recurrent Miscarriage
Official Title
The Role of Uterine NK Cells and T Cell Cytokines in Recurrent Miscarriage.
Study Type
Interventional
2. Study Status
Record Verification Date
January 2021
Overall Recruitment Status
Terminated
Study Start Date
March 2010 (undefined)
Primary Completion Date
August 2012 (Actual)
Study Completion Date
August 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Woman's Health University Hospital, Egypt
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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:
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Recurrent Pregnancy Losses
Keywords
uterine natural killer cells, recurrent miscarriages, alloimmunity
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
500 (Actual)
8. Arms, Groups, and Interventions
Arm Title
No treatment
Arm Type
Active Comparator
Arm Description
patients with recurrent miscarriages
Arm Title
OFFICE HYSTEROSCOPY
Arm Type
Active Comparator
Arm Description
Office hysteroscopic endometrial biopsy at the luteal phase of the menestrual cycle
Intervention Type
Device
Intervention Name(s)
office hysteroscopy
Intervention Description
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
Primary Outcome Measure Information:
Title
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.
Time Frame
two years
Secondary Outcome Measure Information:
Title
to set in the horizon the role of immunomodulators as a treatment for RPL and implantation failure
Time Frame
two years
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alaa M Ismail, MD
Organizational Affiliation
women health hospital,assiut university,egypt
Official's Role
Principal Investigator
Facility Information:
Facility Name
Women Health Hospital
City
Assiut
Country
Egypt
12. IPD Sharing Statement
Learn more about this trial
The Role of Uterine NK Cells and T Cell Cytokines in Recurrent Miscarriage
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