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

Recurrent Pregnancy Losses Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01688284
• Other study ID #: UNKTRPL
• Status: Terminated
• Phase: N/A
• Start date: March 2010
• Est. completion date: August 2012

Study information

• Verified date: January 2021
• Source: Woman's Health University Hospital, Egypt
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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:

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 500
• Est. completion date: August 2012
• Est. primary completion date: August 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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).

Related Conditions & MeSH terms

• Abortion, Habitual
• Abortion, Spontaneous
• Recurrent Pregnancy Losses

Intervention

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

Locations

Country	Name	City	State
Egypt	Women Health Hospital	Assiut

Sponsors (1)

Lead Sponsor	Collaborator
Woman's Health University Hospital, Egypt

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	to set in the horizon the role of immunomodulators as a treatment for RPL and implantation failure		two years