Repeated Implantation FailureUNKNCT04867759
Uterine Natural Killer (uNK) Cell Expression in Patients With Repeated ICSI Failures: A Multicenter Cohort Study
An observational study of Repeated Implantation Failure and ICSI Failure, run by Tanta University at 1 site in Egypt.
Trial summary
uterine NK (uNK) cells are characterized by a high expression of CD56 (CD56brihgt), lack of CD16 expression, high secretion of cytokines and rather low cytotoxic activity. It has been shown that uNK cells increase in number during the late secretory phase and during early pregnancy. Read more about this study
- Who is it for?
- Ages 20 to 40 years, women only
- Conditions the study is for
- Repeated Implantation Failure, ICSI Failure, uNatural Killer Cells
- What is being tested?
- Endometrial Biopsy
- Type of treatment
- Surgery or procedure
- How many people
- 120 participants
- Where
- 1 siteEgypt
- Study dates
- 1 May 2021to 1 Dec 2024
- 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 40 years
- Women only
- Adult
Study population: Patients with repeated implantation faikure
Who may be able to join
- Patients with IVF/ICSI failures more than 2 times
- Age 20-40 years
Who cannot join
- prior uterine surgery
- immunological disease
- previous testing to uNK cells
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Adel Elgergawy
Tanta, 3111
Adel Elgergawy, MD, +201002057250, dradelali775@gmail.com
About this study
uterine NK (uNK) cells are characterized by a high expression of CD56 (CD56brihgt), lack of CD16 expression, high secretion of cytokines and rather low cytotoxic activity. It has been shown that uNK cells increase in number during the late secretory phase and during early pregnancy. This study was designed to assess the possible role of uNK cells in repeated ICSI failure.
Read the detailed description
For occurrence of the "window of implantation", the endometrium must proliferate, increase in thickness, then, after ovulation, adequately respond to progesterone, and become receptive. Ultrasound examination of the thickness and appearance of the endometrium is an easily performed means of assessing morphological changes occurring in the endometrium during the follicular phase, and is thus used as a measure to predict successful implantation. Indeed, several studies have reported a strong association between endometrial thickness and successful implantation. However, others failed to confirm such an association. The minimal adequate endometrial thickness for successful implantation, as measured in the late proliferative phase, varies between studies, with a range of 6-8 mm. However, although rare, some investigators have reported successful implantation in an endometrium of no more than 5 mm thickness.
Uterine NK cell testing can only be done via an endometrial biopsy. Uterine natural killer cells never come into direct contact with the fetal cells-they only have direct access to placental cells.The biopsy is performed on day 21 of your menstrual cycle, when the NK cell count is at its highest. The procedure is done at outpatient clinics and results take about two weeks to receive. If your NK cell activity reading is greater than 14 % on day 21 biopsy, then diagnosed with high levels of NK cell activity.
- Being tested
- Endometrial Biopsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endometrial BiopsyProcedure or surgery
On outpatient basis, we will take a uterine sample on mid-luteal phase day 21 by Novac curette or pipelle aspirator. Samples of endometrium will be kept in formaline solution and will be sent to National Institute of research and medical sceinces at Alexandria University to be tested for uNK Cells CD56.
| Study group | Role | What they receive |
|---|---|---|
| Study group | On outpatient basis, we will take a uterine sample on mid-luteal phase day 21 by Novac curette or pipelle aspirator. Samples of endometrium will be kept in formaline solution and will be sent to National Institute of research and medical sceinces at Alexandria University to be tested for uNK Cells CD56. Receives: Procedure: Endometrial Biopsy | |
| Control group | On outpatient basis, we will take a uterine sample on mid-luteal phase day 21 by Novac curette or pipelle aspirator. Samples of endometrium will be kept in formaline solution and will be sent to National Institute of research and medical sceinces at Alexandria University to be tested for uNK Cells CD56. Receives: Procedure: Endometrial Biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Level of uNK cells
Measurement of level of uNK cells by flowcytometry
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2021
- Study start1 May 2021
- Primary completion1 Dec 2024 (estimated)
- Study completion1 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Repeated Implantation FailureStudies of the same condition, open and under way.
- More trials run by Tanta 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Collaborators
- Mansoura University, Benha University
- Responsible party
- Principal investigator, Ayman S Dawood, MD, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04867759
- Sponsor's protocol ID
- uNK in ICSI failure
- Acronym
- UNK
- Status last verified
- Feb 2024
- First submitted
- 29 Apr 2021
- Last updated
- 28 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: On valuable request
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Uterine Natural Killer (uNK) Cell Expression in Patients With Repeated ICSI Failures: A Multicenter Cohort Study
- ClinicalTrials.gov ID
- NCT04867759
- Acronym / sponsor ID
- UNK / uNK in ICSI failure
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Collaborators
- Mansoura University, Benha University
- Study start
- 1 May 2021 (actual)
- Primary completion
- 1 Dec 2024 (estimated)
- Study completion
- 1 Dec 2024 (estimated)
- First posted
- 30 Apr 2021 (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.
uterine NK (uNK) cells are characterized by a high expression of CD56 (CD56brihgt), lack of CD16 expression, high secretion of cytokines and rather low cytotoxic activity. It has been shown that uNK cells increase in number during the late secretory phase and during early pregnancy. This study was designed to assess the possible role of uNK cells in repeated ICSI failure.
Detailed description
For occurrence of the "window of implantation", the endometrium must proliferate, increase in thickness, then, after ovulation, adequately respond to progesterone, and become receptive. Ultrasound examination of the thickness and appearance of the endometrium is an easily performed means of assessing morphological changes occurring in the endometrium during the follicular phase, and is thus used as a measure to predict successful implantation. Indeed, several studies have reported a strong association between endometrial thickness and successful implantation. However, others failed to confirm such an association. The minimal adequate endometrial thickness for successful implantation, as measured in the late proliferative phase, varies between studies, with a range of 6-8 mm. However, although rare, some investigators have reported successful implantation in an endometrium of no more than 5 mm thickness.
Uterine NK cell testing can only be done via an endometrial biopsy. Uterine natural killer cells never come into direct contact with the fetal cells-they only have direct access to placental cells.The biopsy is performed on day 21 of your menstrual cycle, when the NK cell count is at its highest. The procedure is done at outpatient clinics and results take about two weeks to receive. If your NK cell activity reading is greater than 14 % on day 21 biopsy, then diagnosed with high levels of NK cell activity.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study group | – | Procedure: Endometrial BiopsyOn outpatient basis, we will take a uterine sample on mid-luteal phase day 21 by Novac curette or pipelle aspirator. Samples of endometrium will be kept in formaline solution and will be sent to National Institute of research and medical sceinces at Alexandria University to be tested for uNK Cells CD56. |
| Control group | – | Procedure: Endometrial BiopsyOn outpatient basis, we will take a uterine sample on mid-luteal phase day 21 by Novac curette or pipelle aspirator. Samples of endometrium will be kept in formaline solution and will be sent to National Institute of research and medical sceinces at Alexandria University to be tested for uNK Cells CD56. |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Age groups
- Adult
- Study population
- Patients with repeated implantation faikure
Key inclusion criteria (2 listed)
- Patients with IVF/ICSI failures more than 2 times
- Age 20-40 years
Key exclusion criteria (3 listed)
- prior uterine surgery
- immunological disease
- previous testing to uNK cells
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 |
|---|---|---|
| Endometrial BiopsyOn outpatient basis, we will take a uterine sample on mid-luteal phase day 21 by Novac curette or pipelle aspirator. Samples of endometrium will be kept in formaline solution and will be sent to National Institute of research and medical sceinces at Alexandria University to be tested for uNK Cells CD56. | Procedure or surgery | Control group, Study group |
Primary outcome
Level of uNK cells
Time frame: 4 months
Measurement of level of uNK cells by flowcytometry
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2024.
- Individual participant dataSharing planned: Yes. On valuable request
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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.
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 Repeated Implantation Failure and ICSI Failure, run by Tanta 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 2 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 28 Feb 2024. 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?
Contact Ayman Dawoog, MD (+202020972067, ayman.dawood@med.tanta.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Level of uNK cells (time frame: 4 months). 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 28 Feb 2024.