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

NCT01688284 | Terminated DMC

• 1 other identifier: UNKTRPL
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 1

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).

Conditions

Recurrent Pregnancy Losses

Keywords

uterine natural killer cells; recurrent miscarriages; alloimmunity

Outcome Measures

Primary Outcomes (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.

  two years

Secondary Outcomes (1)

• to set in the horizon the role of immunomodulators as a treatment for RPL and implantation failure

  two years

Study Arms (2)

No treatment

ACTIVE COMPARATOR

patients with recurrent miscarriages

Device: office hysteroscopy

OFFICE HYSTEROSCOPY

ACTIVE COMPARATOR

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

Device: office hysteroscopy

Interventions

office hysteroscopy 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

No treatment; OFFICE HYSTEROSCOPY

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Woman's Health University Hospital, Egypt: lead

Study Sites (1)

Women Health Hospital

Asyut, Egypt

Location

MeSH Terms

Conditions

Abortion, Habitual

Condition Hierarchy (Ancestors)

Abortion, Spontaneous; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Alaa M Ismail, MD

  women health hospital,assiut university,egypt

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor ob/gyn,specialest of infertility and fetal medicine

Study Record Dates

• First Submitted: August 6, 2012
• First Posted: September 19, 2012
• Study Start: March 1, 2010
• Primary Completion: August 1, 2012
• Study Completion: August 1, 2012
• Last Updated: January 7, 2021

Record last verified: 2021-01

Locations

EG (1)