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

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ClinicalTrials.gov Identifier: NCT01688284
Recruitment Status : Terminated
First Posted : September 19, 2012
Last Update Posted : January 7, 2021
Sponsor:
Information provided by (Responsible Party):
alaa eldeen mahmoud ismail, Woman's Health University Hospital, Egypt

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).

Condition or disease Intervention/treatment Phase
Recurrent Pregnancy Losses Device: office hysteroscopy Not Applicable

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:

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 500 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: The Role of Uterine NK Cells and T Cell Cytokines in Recurrent Miscarriage.
Study Start Date : March 2010
Actual Primary Completion Date : August 2012
Actual Study Completion Date : August 2012

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: No treatment
patients with recurrent miscarriages
Device: office hysteroscopy
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

Active Comparator: OFFICE HYSTEROSCOPY
Office hysteroscopic endometrial biopsy at the luteal phase of the menestrual cycle
Device: office hysteroscopy
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 Measures :
  1. 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 Measures :
  1. to set in the horizon the role of immunomodulators as a treatment for RPL and implantation failure [ Time Frame: two years ]


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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Women with unexplained recurrent miscarriages (2 or more consecutive).
  2. All patients have normal uterine cavity diagnosed by HSG and /or hysteroscopy, normal semen analysis, normal thrombophilic profiles, no history of malformed
  3. normal fetus in the previous miscarriages

Exclusion Criteria:

  1. Age above forty years old .
  2. Antiphospholipid syndrome (lupus anticoagulant and/or anticardiolipin antibodies [IgG or IgM]); other recognised thrombophilic conditions (testing according to usual clinic practice).
  3. Intrauterine abnormalities (as assessed by ultrasound, hysterosonography, hysterosalpingogram, or hysteroscopy).
  4. Fibroids distorting uterine cavity .
  5. Abnormal parental karyotype .
  6. Other identifiable causes of recurrent miscarriages (tests initiated only if clinically indicated) e.g., diabetes, thyroid disease and systemic lupus erythematosus (SLE).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01688284


Locations
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Egypt
Women Health Hospital
Assiut, Egypt
Sponsors and Collaborators
Woman's Health University Hospital, Egypt
Investigators
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Principal Investigator: Alaa M Ismail, MD women health hospital,assiut university,egypt
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Responsible Party: alaa eldeen mahmoud ismail, Assistant professor ob/gyn,specialest of infertility and fetal medicine, Woman's Health University Hospital, Egypt
ClinicalTrials.gov Identifier: NCT01688284    
Other Study ID Numbers: UNKTRPL
First Posted: September 19, 2012    Key Record Dates
Last Update Posted: January 7, 2021
Last Verified: January 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by alaa eldeen mahmoud ismail, Woman's Health University Hospital, Egypt:
uterine natural killer cells
recurrent miscarriages
alloimmunity
Additional relevant MeSH terms:
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Abortion, Spontaneous
Abortion, Habitual
Pregnancy Complications