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

Not Applicable

Terminated

• Conditions: Recurrent Pregnancy Losses
• Interventions: Device: office hysteroscopy

• Registration Number: NCT01688284
• Lead Sponsor: 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).

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:

Study Timeline

• Study Start: 2010-03
• Primary Completion: 2012-08
• Study Completion: 2012-08
• Study First Submitted: 2012-08-06
• Study First Submitted QC: 2012-09-18
• Study First Posted: 2012-09-19
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-06
• Last Update Posted: 2021-01-07

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 500

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
No treatment	office hysteroscopy	patients with recurrent miscarriages
OFFICE HYSTEROSCOPY	office hysteroscopy	Office hysteroscopic endometrial biopsy at the luteal phase of the menestrual cycle

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
to set in the horizon the role of immunomodulators as a treatment for RPL and implantation failure	two years

Trial Locations

Locations (1)

Women Health Hospital; 🇪🇬 Assiut, Egypt