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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

500 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-03-31

Study Completion Date

2012-08-31

Brief Summary

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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).

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Detailed Description

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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:

Conditions

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Recurrent Pregnancy Losses

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

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No treatment

patients with recurrent miscarriages

Group Type ACTIVE_COMPARATOR

office hysteroscopy

Intervention Type DEVICE

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

OFFICE HYSTEROSCOPY

Office hysteroscopic endometrial biopsy at the luteal phase of the menestrual cycle

Group Type ACTIVE_COMPARATOR

office hysteroscopy

Intervention Type DEVICE

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

Interventions

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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

Intervention Type DEVICE

Eligibility Criteria

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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).

Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes