FemaleNCT03941470
Assessment of Natural Killer Cells in Unexplained Recurrent Pregnancy Loss
An observational study of Female and Recurrent Miscarriage, run by Assiut University at 1 site in Egypt.
Trial summary
To assess natural killer cells frequency and activation in cases of unexplained recurrent abortion in comparison to fertile cases 2. . To study the expression of stimulatory receptors of natural killer cell. 3-To study the expression of inhibitory receptors of natural killer cell. Read more about this study
- Who is it for?
- Ages Up to 35 years, women only
- Conditions the study is for
- Female, Recurrent Miscarriage, Unexplained Pregnancy Loss
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 30 Apr 2019to 20 Jul 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 35 years
- Women only
- No healthy volunteers
- Child, Adult
Study population: We will recruit patients from outpatient clinics from Assuit University Hospital,Women fulfilling eligibility criteria will be included after careful gynecologycal examination,Those who consent to participate will be referred to the lab for investigation.
Who may be able to join
- 1.Age less than 40 years. 2.History of two or more spontaneous miscarriages .
Who cannot join
- 1. Age more than 35 years. 2. Women with elevated level of TSH above (2.5 mIU/ml) or prolactin above( 19.5 ng/mL)and uncontrolled DM.
- 3. Women with autoimmune disorder (antiphospholipid antibody syndrome)with LA1/LA2 ratio more than( 1.2).
- 4.Women receiving oral contraceptive pills.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessment of Natural Killer Cells Activating and Inhibitors
To assess natural killer cells frequency and activation in cases of unexplained recurrent abortion in comparison to fertile cases
- 2. . To study the expression of stimulatory receptors of natural killer cell.
- 3-To study the expression of inhibitory receptors of natural killer cell.
Read the detailed description
NK-cell functioning is controlled by a wide range of receptors that are expressed on the cell surface. These receptors are either inhibitory or activating in nature. The family of inhibitory receptors consists of the killer immunoglobulin-like receptors (KIR) or Ig-like receptors (CD158), the C type lectin receptors (CD94-NKG2A) and leukocyte inhibitory receptors (LIR1, LAIR-1). Activating receptors are the natural cytotoxic receptors (NKp46, NKp44), C type lectin receptors (NKG2D, CD94-NKG2C), and Ig-like receptors (2B4). A particular NK cell typically expresses two to four inhibitory receptors in addition to an array of activation receptors. The killing by NK cells is mediated through several activating NK receptors. Among these are NKG2D and the three natural cytotoxicity receptors (NCRs), NKp30, NKp44, and NKp46 (Yang et al., 2000) Osne of the natural cytotoxicity receptors (NCRs) NKp46, , is a unique marker that functions in NK cell cytotoxicity and cytokine production. Expression of NKp46 on NK cells is lower in women with recurrent pregnancy loss, so evaluation of NKp46 on peripheral blood NK cells may provide a means of screening for reproductive abnormalities (Fukui et al., 2015).
During pregnancy, decidual NK cells comprise ∼70-80% of the decidual lymphocytes and are considered a special NK subset that does not exert cytolytic functions against trophoblast cells and has generally reduced cytotoxicity (Hanna and Mandelboim, 2007).
These cells express activating NK receptors, including all the NCRs and NKG2D. However, instead of triggering cytotoxicity, these receptors act to stimulate secretion of cytokines and angiogenic factors, which are essential for trophoblast invasion and vascular modifications (Hanna et al., 2006).
One study reported that pNK cell levels show changes in decidual NK cell levels (Park et al., 2010). Whereas some other reports have shown that the assessment of peripheral blood NK cells would not
- Conditions
- Female, Recurrent Miscarriage, Unexplained Pregnancy Loss
- Keywords
- NK ;natural killer cells
- Medical subject headings
- Abortion, Habitual
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| unexplained recurrent pregnancy loss | peripheral blood sample examined by flowcytometry | |
| control fertile multipara | peripheral blood sample examined by flowcytometry |
What is being measured
The primary outcome is the main question the study is designed to answer.
asses the number of Natural killer cells
flowcytometry
Measured: 15 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2019
- Study start30 Apr 2019
- Primary completion1 Dec 2019 (estimated)
- Study completion20 Jul 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for FemaleStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Other
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yossra Mahmoud Mohammed, Assiut University
- Investigators
- assiut university, Principal investigator, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03941470
- Sponsor's protocol ID
- 17200339
- Status last verified
- May 2019
- First submitted
- 6 May 2019
- Last updated
- 8 May 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Fukui A, Kamoi M, Funamizu A, Fuchinoue K, Chiba H, Yokota M, Fukuhara R, Mizunuma H. NK cell abnormality and its treatment in women with reproductive failures such as recurrent pregnancy loss, implantation failures, preeclampsia, and pelvic endometriosis. Reprod Med Biol. 2015 Apr 11;14(4):151-157. doi: 10.1007/s12522-015-0207-7. eCollection 2015 Oct.
PubMed 29259412
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Natural Killer Cells Activating and Inhibitors
- ClinicalTrials.gov ID
- NCT03941470
- Acronym / sponsor ID
- 17200339
- Conditions
- Female, Recurrent Miscarriage, Unexplained Pregnancy Loss
- Keywords
- NK ;natural killer cells
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 30 Apr 2019 (actual)
- Primary completion
- 1 Dec 2019 (estimated)
- Study completion
- 20 Jul 2020 (estimated)
- First posted
- 8 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To assess natural killer cells frequency and activation in cases of unexplained recurrent abortion in comparison to fertile cases
- 2. . To study the expression of stimulatory receptors of natural killer cell.
- 3-To study the expression of inhibitory receptors of natural killer cell.
Detailed description
NK-cell functioning is controlled by a wide range of receptors that are expressed on the cell surface. These receptors are either inhibitory or activating in nature. The family of inhibitory receptors consists of the killer immunoglobulin-like receptors (KIR) or Ig-like receptors (CD158), the C type lectin receptors (CD94-NKG2A) and leukocyte inhibitory receptors (LIR1, LAIR-1). Activating receptors are the natural cytotoxic receptors (NKp46, NKp44), C type lectin receptors (NKG2D, CD94-NKG2C), and Ig-like receptors (2B4). A particular NK cell typically expresses two to four inhibitory receptors in addition to an array of activation receptors. The killing by NK cells is mediated through several activating NK receptors. Among these are NKG2D and the three natural cytotoxicity receptors (NCRs), NKp30, NKp44, and NKp46 (Yang et al., 2000) Osne of the natural cytotoxicity receptors (NCRs) NKp46, , is a unique marker that functions in NK cell cytotoxicity and cytokine production. Expression of NKp46 on NK cells is lower in women with recurrent pregnancy loss, so evaluation of NKp46 on peripheral blood NK cells may provide a means of screening for reproductive abnormalities (Fukui et al., 2015).
During pregnancy, decidual NK cells comprise ∼70-80% of the decidual lymphocytes and are considered a special NK subset that does not exert cytolytic functions against trophoblast cells and has generally reduced cytotoxicity (Hanna and Mandelboim, 2007).
These cells express activating NK receptors, including all the NCRs and NKG2D. However, instead of triggering cytotoxicity, these receptors act to stimulate secretion of cytokines and angiogenic factors, which are essential for trophoblast invasion and vascular modifications (Hanna et al., 2006).
One study reported that pNK cell levels show changes in decidual NK cell levels (Park et al., 2010). Whereas some other reports have shown that the assessment of peripheral blood NK cells would not
Study design
- Observational model
- Case-control
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| unexplained recurrent pregnancy loss | – | –peripheral blood sample examined by flowcytometry |
| control fertile multipara | – | –peripheral blood sample examined by flowcytometry |
Who may qualify
- Ages
- Up to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- We will recruit patients from outpatient clinics from Assuit University Hospital,Women fulfilling eligibility criteria will be included after careful gynecologycal examination,Those who consent to participate will be referred to the lab for investigation.
Key inclusion criteria (1 listed)
- 1.Age less than 40 years. 2.History of two or more spontaneous miscarriages .
Key exclusion criteria (3 listed)
- 1. Age more than 35 years. 2. Women with elevated level of TSH above (2.5 mIU/ml) or prolactin above( 19.5 ng/mL)and uncontrolled DM.
- 3. Women with autoimmune disorder (antiphospholipid antibody syndrome)with LA1/LA2 ratio more than( 1.2).
- 4.Women receiving oral contraceptive pills.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
asses the number of Natural killer cells
Time frame: 15 month
flowcytometry
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2019.
- Results publication: PubMed 29259412Fukui A, Kamoi M, Funamizu A, Fuchinoue K, Chiba H, Yokota M, Fukuhara R, Mizunuma H. NK cell abnormality and its treatment in women with reproductive failures such as recurrent pregnancy loss, implantation failures, preeclampsia, and pelvic endometriosis. Reprod Med Biol. 2015 Apr 11;14(4):151-157. doi: 10.1007/s12522-015-0207-7. eCollection 2015 Oct.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
assiut university principal investigator
Assiut University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Female and Recurrent Miscarriage, run by Assiut University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
asses the number of Natural killer cells (time frame: 15 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03941470, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2019.