MiscarriageNCT04492098
Mucosal-Associated Invariant T Cells in Cases of Miscarriage
An observational study of Miscarriage, run by Assiut University at 1 site in Egypt.
Trial summary
Miscarriage is the most frequently encountered complication of pregnancy ranging from 10% to 30%. The etiology of recurrent spontaneous miscarriage (RSM) in 40%-50% of cases cannot be identified. Immunological disturbances have been suggested to play an important role. Read more about this study
- Who is it for?
- Ages 20 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Miscarriage
- What is being tested?
- MAIT cells
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jun 2021to 1 Dec 2022
- 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 20 to 35 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: All pregnant women presented with spontaneous miscarriage
Who may be able to join
- Regular marital life with the same partner.
- Regularly menstruating before current pregnancy.
- Spontaneous conception.
Who cannot join
- Women with Polycystic ovarian syndrome or any endocrinal abnormalities like DM, thyroid disorders.
- History of abnormal uterine cavity proved by sonohysterography or hysteroscopy before pregnancy.
- Women with positive consanguinity.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Analysis of Mucosal-Associated Invariant T (MAIT) Cells in Cases of Spontaneous and Recurrent Miscarriage
Miscarriage is the most frequently encountered complication of pregnancy ranging from 10% to 30%. The etiology of recurrent spontaneous miscarriage (RSM) in 40%-50% of cases cannot be identified. Immunological disturbances have been suggested to play an important role.
Previous studies have focused that women with miscarriage have elevated NK cell numbers and activity both in the periphery and in the endometrium. Also, NK cells in women with RSM displayed an imbalance of Killer cell Ig-like receptors (KIRs) in favor of activating KIR leading to an unbalanced activation of dNK cytotoxicity and higher risk of miscarriage.
- Conditions
- Miscarriage
- Being tested
- MAIT cells
- Medical subject headings
- Abortion, Spontaneous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MAIT cellsDiagnostic test
1- Decidual tissues will be washed in phosphate buffer saline (PBS), and then preserved in Rosewell Park Memorial Institute (RPMI) 1640 medium supplemented with 100 U/mL penicillin, 100 mg/mL streptomycin and 5% fetal bovine serum (GIBCO BRL, Thermo Fisher Scientific, USA) until transfer to the laboratory. At the flow cytometry laboratory, the tissue samples will be minced finely and enzymatically digested by adding 3 ml collagenase enzyme type Ia and 2 ml PBS for 40 minutes at 37°C in shaking water path at 100 r.p.m. Cell suspensions obtained will be filtered, then the pellet after centrifugation will be treated with red blood cells lysing solution and washed with PBS.
| Study group | Role | What they receive |
|---|---|---|
| study group | women with spontaneous miscarriage Receives: Diagnostic Test: MAIT cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
The percentages of MAIT cells and MAIT cells expressing CD56 and CD16 in comparison with NK cells and NKT cells in both blood and decidua
All markers will be measured by flow cytometry
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2020
- Study start1 Jun 2021
- Primary completion1 Oct 2022
- Study completion1 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MiscarriageStudies 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Mohamed Abbas, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04492098
- Sponsor's protocol ID
- MAIT-RPL
- Status last verified
- Jan 2023
- First submitted
- 27 Jul 2020
- Last updated
- 31 Jan 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of Mucosal-Associated Invariant T (MAIT) Cells in Cases of Spontaneous and Recurrent Miscarriage
- ClinicalTrials.gov ID
- NCT04492098
- Acronym / sponsor ID
- MAIT-RPL
- Conditions
- Miscarriage
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Jun 2021 (actual)
- Primary completion
- 1 Oct 2022 (actual)
- Study completion
- 1 Dec 2022 (actual)
- First posted
- 30 Jul 2020 (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.
Miscarriage is the most frequently encountered complication of pregnancy ranging from 10% to 30%. The etiology of recurrent spontaneous miscarriage (RSM) in 40%-50% of cases cannot be identified. Immunological disturbances have been suggested to play an important role.
Previous studies have focused that women with miscarriage have elevated NK cell numbers and activity both in the periphery and in the endometrium. Also, NK cells in women with RSM displayed an imbalance of Killer cell Ig-like receptors (KIRs) in favor of activating KIR leading to an unbalanced activation of dNK cytotoxicity and higher risk of miscarriage.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| study group | – | Diagnostic Test: MAIT cellswomen with spontaneous miscarriage |
Who may qualify
- Ages
- 20 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- All pregnant women presented with spontaneous miscarriage
Key inclusion criteria (3 listed)
- Regular marital life with the same partner.
- Regularly menstruating before current pregnancy.
- Spontaneous conception.
Key exclusion criteria (3 listed)
- Women with Polycystic ovarian syndrome or any endocrinal abnormalities like DM, thyroid disorders.
- History of abnormal uterine cavity proved by sonohysterography or hysteroscopy before pregnancy.
- Women with positive consanguinity.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MAIT cells1- Decidual tissues will be washed in phosphate buffer saline (PBS), and then preserved in Rosewell Park Memorial Institute (RPMI) 1640 medium supplemented with 100 U/mL penicillin, 100 mg/mL streptomycin and 5% fetal bovine serum (GIBCO BRL, Thermo Fisher Scientific, USA) until transfer to the laboratory. At the flow cytometry laboratory, the tissue samples will be minced finely and enzymatically digested by adding 3 ml collagenase enzyme type Ia and 2 ml PBS for 40 minutes at 37°C in shaking water path at 100 r.p.m. Cell suspensions obtained will be filtered, then the pellet after centrifugation will be treated with red blood cells lysing solution and washed with PBS. | Diagnostic test | study group |
Primary outcome
The percentages of MAIT cells and MAIT cells expressing CD56 and CD16 in comparison with NK cells and NKT cells in both blood and decidua
Time frame: 24 hours
All markers will be measured by flow cytometry
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2023.
Related trials for Miscarriage
Not yet recruitingObservational study
Predictors of Successful Office Operative Hysteroscopy Using a Mini-Resectoscope
Retained Products of Conception, Hysteroscopy
Recruiting
GRACE - Genetic Insights Into Early pRegnancy Loss Using Cell-free fEtal DNA
Miscarriage in First Trimester, Prenatal Genetic Diagnosis
Not yet recruitingObservational study
Cohort Study on the Levels of Placental Growth Factor and Nucleosomes in Early Pregnancy and Adverse Pregnancy Outcomes
Preeclampsia, Premature Birth
Recruiting
Hysteroscopic Resection Versus Manual Vacuum Aspiration for Early Pregnancy
Miscarriage in First Trimester
Not yet recruiting
Cost-utility Analysis of Outpatient Manual Vacuum Aspiration Versus Operating Room Electric Aspiration for the Management of First-trimester Miscarriage
Miscarriage, Pregnancy Loss
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.
The record lists no contact. Use the official record to reach the sponsor.
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 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 3 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: finished, as of the sponsor's last update on 31 Jan 2023. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
The percentages of MAIT cells and MAIT cells expressing CD56 and CD16 in comparison with NK cells and NKT cells in both blood and decidua (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 31 Jan 2023; AzTrials last refreshed its copy on 7 Nov 2026.