Abortion, HabitualPhase 1NCT06821685
Autologous Decidual-like Natural Killer Cells Therapy for Infertility or Adverse Pregnancy History
A Phase 1 study testing autologous decidual-like NK cells in people with Abortion, Habitual and Infertility Unexplained, run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School at 1 site in China.
Trial summary
The aim of this study is preliminary exploration of the effectiveness and duration of autologous decidual-like NK cells therapy in improving uterine NK cells dysfunction. Read more about this study
- Who is it for?
- Ages 22 to 40 years, women only
- Conditions the study is for
- Abortion, Habitual, Infertility Unexplained, Embryo Implantation
- What is being tested?
- autologous decidual-like NK cells
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteChina
- Study dates
- 13 Feb 2025to Dec 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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 22 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- abnormal uterine NK cell function;
- have one of the following medical history: unexplained recurrent spontaneous abortions (≥2 spontaneous abortions, including biochemical pregnancy), repeated implantation failure (failure of implantation of good-quality embryos in at least two IVF cycles), unexplained infertility, early-onset severe gestational hypertension or early-onset fetal growth restriction;
- have clear fertility desires;
- normal ovarian function or with frozen embryos;
- edometrium thickness measured by vaginal ultrasound before ovulation or at mid-luteal phase >= 7mm;
- 18kg/m^2 < Body mass index < 30kg/m^2;
Who cannot join
- using progesterone receptor modulator;
- chromosomal karyotype abnormalities in one spouse;
- severe endometriosis, uterine fibroids affecting the shape of the uterine cavity or the size of the whole uterus more than 2 and a half months of pregnancy, uterine malformation, uterine adhesion or thin endometrium;
- uncontrolled autoimmune diseases;
- abnormal blood coagulation function, abnormal liver and kidney function, or other uncontrolled basic diseases (hypertension, diabetes, thyroid disease, etc.) that the researcher access which may affect the progress of the study;
- history of pelvic malignant tumors;
- currently participating in other clinical studies;
- allergic to blood products.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The Affiliated Drum Tower Hospital of Nanjing University
Nanjing, Jiangsu, 210006
Yali Hu
About this study
Official title: Clinical Study of Autologous Decidual-like Natural Killer Cells Therapy for Infertility or Adverse Pregnancy History Caused by Abnormal Uterine Natural Killer Cells
The aim of this study is preliminary exploration of the effectiveness and duration of autologous decidual-like NK cells therapy in improving uterine NK cells dysfunction.
Read the detailed description
Menstrual blood analysis will be performed on patients with infertility or a history of adverse pregnancy outcomes who have fertility needs. Those with abnormal uterine NK cells function will be screened and given informed consent forms pre-treatment. Collecting peripheral blood from the patients, isolating and inducing in vitro culture to obtain autologous decidual like NK cells which will be perfused into their uterine. Perform continuous menstrual blood analysis within 6 months after the first treatment to assess the improvement of uterine NK cell function. If the function of uterine NK cells improves, enter the stage of attempting pregnancy and follow up pregnancy outcomes; If the function of uterine NK cells does not improve, then autologous decidual like NK cells uterine cavity perfusion therapy will be performed again. NK cells intrauterine infusion will be treated up to 2 times.
- Being tested
- autologous decidual-like NK cells
- Keywords
- recurrent pregnancy loss, repeated implantation failure, unexplained infertility, decidual natural killer cells
- Medical subject headings
- Abortion, Habitual, Pre-Eclampsia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
autologous decidual-like NK cellsBiological
intrauterine infusion
| Study group | Role | What they receive |
|---|---|---|
| autologous decidual-like NK cells | Experimental | Autologous decidual like NK cells will be isolated and induced in vitro culture from the patients' peripheral blood and perfused into their uterine. Receives: Biological: autologous decidual-like NK cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement rate of NK cells
Improvement rate of NK cells in menstrual blood of patients after intrauterine infusion of autologous decidual like NK cells
Measured: 6 months after the first intrauterine infusion therapy
Secondary outcomes (6)
Duration of improvement in NK cells
Duration of improvement in NK cells in menstrual blood of patients after intrauterine infusion of autologous decidual like NK cells
Measured: 6 months after the first intrauterine infusion therapy
Clinical pregnancy
Ultrasound indicates the presence of a gestational sac and fetal heartbeat in the uterine cavity
Measured: 1 year after completion of NK cells therapy
Ongoing pregnancy
At least 12 weeks of pregnancy, ultrasound indicates that the fetus has cardiac activity and the size of the fetus matches the gestational age
Measured: 1 year after completion of NK cells therapy
Live birth
Delivery of any number of neonates born at 26 or more weeks' gestation with signs of life
Measured: 1 year after completion of NK cells therapy
preeclampsia
The occurrence of preeclampsia during successful ongoing pregnancy after cell therapy
Measured: 1 year after completion of NK cells therapy
fetal growth restriction
The occurrence of fetal growth restriction during successful ongoing pregnancy after cell therapy
Measured: 1 year after completion of NK cells therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2025
- Study start13 Feb 2025
- Primary completionJul 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Abortion, HabitualStudies of the same condition, open and under way.
- More trials run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical SchoolThe 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
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 14 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- The University of Science and Technology of China
- Responsible party
- Sponsor
- Investigators
- Yali Hu, Principal investigator, The Affiliated Drum Tower Hospital of Nanjing UniversityHui Zhu, Principal investigator, The Affiliated Drum Tower Hospital of Nanjing University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06821685
- Sponsor's protocol ID
- 2024-LCYJ-PY-50
- Status last verified
- Jun 2025
- First submitted
- 6 Feb 2025
- Last updated
- 17 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study of Autologous Decidual-like Natural Killer Cells Therapy for Infertility or Adverse Pregnancy History Caused by Abnormal Uterine Natural Killer Cells
- ClinicalTrials.gov ID
- NCT06821685
- Acronym / sponsor ID
- 2024-LCYJ-PY-50
- Keywords
- recurrent pregnancy loss, repeated implantation failure, unexplained infertility, decidual natural killer cells
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 14 participants (estimated)
- Lead sponsor
- The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical SchoolUniversity, hospital or other
- Collaborators
- The University of Science and Technology of China
- Study start
- 13 Feb 2025 (actual)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 12 Feb 2025 (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.
The aim of this study is preliminary exploration of the effectiveness and duration of autologous decidual-like NK cells therapy in improving uterine NK cells dysfunction.
Detailed description
Menstrual blood analysis will be performed on patients with infertility or a history of adverse pregnancy outcomes who have fertility needs. Those with abnormal uterine NK cells function will be screened and given informed consent forms pre-treatment. Collecting peripheral blood from the patients, isolating and inducing in vitro culture to obtain autologous decidual like NK cells which will be perfused into their uterine. Perform continuous menstrual blood analysis within 6 months after the first treatment to assess the improvement of uterine NK cell function. If the function of uterine NK cells improves, enter the stage of attempting pregnancy and follow up pregnancy outcomes; If the function of uterine NK cells does not improve, then autologous decidual like NK cells uterine cavity perfusion therapy will be performed again. NK cells intrauterine infusion will be treated up to 2 times.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| autologous decidual-like NK cells | Experimental | Biological: autologous decidual-like NK cellsAutologous decidual like NK cells will be isolated and induced in vitro culture from the patients' peripheral blood and perfused into their uterine. |
Who may qualify
- Ages
- 22 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- abnormal uterine NK cell function;
- have one of the following medical history: unexplained recurrent spontaneous abortions (≥2 spontaneous abortions, including biochemical pregnancy), repeated implantation failure (failure of implantation of good-quality embryos in at least two IVF cycles), unexplained infertility, early-onset severe gestational hypertension or early-onset fetal growth restriction;
- have clear fertility desires;
- normal ovarian function or with frozen embryos;
- edometrium thickness measured by vaginal ultrasound before ovulation or at mid-luteal phase >= 7mm;
Key exclusion criteria (8 listed)
- using progesterone receptor modulator;
- chromosomal karyotype abnormalities in one spouse;
- severe endometriosis, uterine fibroids affecting the shape of the uterine cavity or the size of the whole uterus more than 2 and a half months of pregnancy, uterine malformation, uterine adhesion or thin endometrium;
- uncontrolled autoimmune diseases;
- abnormal blood coagulation function, abnormal liver and kidney function, or other uncontrolled basic diseases (hypertension, diabetes, thyroid disease, etc.) that the researcher access which may affect the progress of the study;
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 |
|---|---|---|
| autologous decidual-like NK cellsintrauterine infusion | Biological | autologous decidual-like NK cells |
Primary outcome
Improvement rate of NK cells
Time frame: 6 months after the first intrauterine infusion therapy
Improvement rate of NK cells in menstrual blood of patients after intrauterine infusion of autologous decidual like NK cells
6 secondary outcomes
Duration of improvement in NK cells
Time frame: 6 months after the first intrauterine infusion therapy
Clinical pregnancy
Time frame: 1 year after completion of NK cells therapy
Ongoing pregnancy
Time frame: 1 year after completion of NK cells therapy
Live birth
Time frame: 1 year after completion of NK cells therapy
preeclampsia
Time frame: 1 year after completion of NK cells therapy
fetal growth restriction
Time frame: 1 year after completion of NK cells therapy
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2025.
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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.
Yali Hu principal investigator
The Affiliated Drum Tower Hospital of Nanjing University
Hui Zhu principal investigator
The Affiliated Drum Tower Hospital of Nanjing University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing autologous decidual-like NK cells in people with Abortion, Habitual and Infertility Unexplained, run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School at 1 site in China.
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 6 inclusion and 8 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: looking for participants now, as of the sponsor's last update on 17 Nov 2025. 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 China. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yali Hu (86-025-83106666 ext. 11201, glyyhuyali@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement rate of NK cells (time frame: 6 months after the first intrauterine infusion therapy). 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 17 Nov 2025.