Recurrent Pregnancy LossesNCT01688284
The Role of Uterine NK Cells and T Cell Cytokines in Recurrent Miscarriage
A study testing office hysteroscopy in people with Recurrent Pregnancy Losses, run by Woman's Health University Hospital, Egypt at 1 site in Egypt.
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). Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Recurrent Pregnancy Losses
- What is being tested?
- office hysteroscopy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 1 siteEgypt
- Study dates
- Mar 2010to Aug 2012
- Phase
- Interventional
- 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 18 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Role of Uterine NK Cells and T Cell Cytokines in Recurrent Miscarriage.
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).
Read the 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:
- Conditions
- Recurrent Pregnancy Losses
- Being tested
- office hysteroscopy
- Keywords
- uterine natural killer cells, recurrent miscarriages, alloimmunity
- Medical subject headings
- Abortion, Habitual
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
office hysteroscopyDevice
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
| Study group | Role | What they receive |
|---|---|---|
| No treatment | Active comparator | patients with recurrent miscarriages Receives: Device: office hysteroscopy |
| OFFICE HYSTEROSCOPY | Active comparator | Office hysteroscopic endometrial biopsy at the luteal phase of the menestrual cycle Receives: Device: office hysteroscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: two years
Secondary outcomes (1)
to set in the horizon the role of immunomodulators as a treatment for RPL and implantation failure
Measured: two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2012 (estimated)
- Study startMar 2010
- Primary completionAug 2012
- Study completionAug 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Recurrent Pregnancy LossesStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 500 participants (actual)
Sponsor and investigators
- Lead sponsor
- Woman's Health University Hospital, Egypt
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, alaa eldeen mahmoud ismail, Woman's Health University Hospital, Egypt
- Investigators
- Alaa M Ismail, MD, Principal investigator, women health hospital,assiut university,egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01688284
- Sponsor's protocol ID
- UNKTRPL
- Status last verified
- Jan 2021
- First submitted
- 6 Aug 2012
- Last updated
- 7 Jan 2021
- 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 7 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Uterine NK Cells and T Cell Cytokines in Recurrent Miscarriage.
- ClinicalTrials.gov ID
- NCT01688284
- Acronym / sponsor ID
- UNKTRPL
- Conditions
- Recurrent Pregnancy Losses
- Keywords
- uterine natural killer cells, recurrent miscarriages, alloimmunity
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 500 participants (actual)
- Lead sponsor
- Woman's Health University Hospital, EgyptUniversity, hospital or other
- Study start
- Mar 2010
- Primary completion
- Aug 2012 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 19 Sep 2012 (estimated)
- 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.
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 design
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| No treatment | Active comparator | Device: office hysteroscopypatients with recurrent miscarriages |
| OFFICE HYSTEROSCOPY | Active comparator | Device: office hysteroscopyOffice hysteroscopic endometrial biopsy at the luteal phase of the menestrual cycle |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (6 listed)
- 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 .
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 |
|---|---|---|
| office hysteroscopyEndometrial 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 | Device | No treatment, OFFICE HYSTEROSCOPY |
Primary outcome
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.
Time frame: two years
1 secondary outcome
to set in the horizon the role of immunomodulators as a treatment for RPL and implantation failure
Time frame: two years
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2021.
Related trials for Recurrent Pregnancy Losses
RecruitingObservational study
Cohort of Patients Presenting Unexplained Recurrent Miscarriages and Identification of Early Miscarriage Recidivism Factors
Miscarriage, Early Pregnancy Loss
Not yet recruitingObservational study
On Pregnancy After Losses - OPAL Study
Recurrent 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.
Alaa M Ismail, MD principal investigator
women health hospital,assiut university,egypt
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing office hysteroscopy in people with Recurrent Pregnancy Losses, run by Woman's Health University Hospital, Egypt 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 6 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: stopped early, as of the sponsor's last update on 7 Jan 2021. 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 was stopped early. 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?
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. (time frame: two years). 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 7 Jan 2021.