Abortion, MissedPhase 2NCT07230574
Autologous Decidual-like Natural Killer Cells Therapy for Reproductive Failure
A Phase 2 study testing NK cell perfusion group in people with Abortion, Missed and Infertility Unexplained, run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School.
Trial summary
The aim of this study is to verify the efficacy of in vitro induction of autologous decidual-like NK cells therapy for reproductive failure associated with uterine NK cells abnormalities. Read more about this study
- Who is it for?
- Ages 22 to 38 years, women only
- Conditions the study is for
- Abortion, Missed, Infertility Unexplained, Reproductive Disorder
- What is being tested?
- NK cell perfusion group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 159 participants
- Where
- No sites listed yet
- Study dates
- Nov 2025to Sep 2028
- Phase
- Phase 2
- 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 38 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Reproductive failure with abnormal endometrial natural killer (NK) cells in menstrual blood;
- With a clear intention to conceive;
- Normal ovarian function, or premature ovarian insufficiency with ≥2 high-quality cryopreserved embryos available for transfer;
- Endometrial thickness measured by transvaginal ultrasound during the periovulatory period ≥7 mm;
- Body mass index (BMI) between 18 kg/m² and 28 kg/m²;
- Willing to comply with the follow-up plan of this study.
Who cannot join
- Use of progesterone receptor modulators;
- One of the couple's chromosomal karyotype abnormalities, with no euploid embryo identified via preimplantation genetic testing for aneuploidy;
- Severe endometriosis or adenomyosis, uterine fibroids affecting uterine cavity morphology, uterine malformations, intrauterine adhesions, or thin endometrium;
- Uncontrolled autoimmune or endocrine disorders;
- Contraindications to pregnancy;
- History of malignant tumors;
- Participating in other clinical studies;
- Allergy to blood products.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Prospective, Multicenter, Randomized Controlled Clinical Study on Autologous Decidual-like NK Cells Therapy for Reproductive Failure Associated With Abnormal Uterine Natural Killer Cells
The aim of this study is to verify the efficacy of in vitro induction of autologous decidual-like NK cells therapy for reproductive failure associated with uterine NK cells abnormalities.
Read the detailed description
Participants with reproductive failure and reproductive intentions will be recruited and screened. After obtaining their informed consent, menstrual blood analysis will be performed. Participants with menstrual blood NK cell abnormalities will be randomly assigned to either the NK cell perfusion group or control group in a ratio of 2:1. After completing two rounds of NK cell therapy, the NK cell perfusion group will enter the follow-up period, while the control group will not receive interventions after randomization and enter the follow-up period directly. The following information will be recorded for all participants who undergo menstrual blood NK cell analysis, including menstrual blood analysis results, attempts to conceive, and pregnancy outcomes during the follow-up period.
- Being tested
- NK cell perfusion group
- Keywords
- Recurrent Pregnancy Loss, Repeated Implantation Failure, Unexplained Infertility, Decidual Natural Killer Cells
- Medical subject headings
- Abortion, Missed
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NK cell perfusion groupBiological
Completing two rounds of NK cell therapy
| Study group | Role | What they receive |
|---|---|---|
| NK cell perfusion group | Experimental | Accepting NK cell therapy Receives: Biological: NK cell perfusion group |
| Control group | No intervention | Not accepting NK cell therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ongoing pregnancy rate
Ongoing pregnancy is defined as at least 12 weeks of gestation, with ultrasound indicating fetal cardiac activity and fetal size consistent with the gestational age
Measured: 6 months, if a participant is confirmed to get a clinically pregnancy during this period, the follow-up endpoint will be extended until there is a pregnancy outcome
Secondary outcomes (5)
Improvement rate of NK cells
Improvement rate of NK cells in menstrual blood analysis after intrauterine perfusion of autologous decidual-like NK cells
Measured: 6 months
Clinical pregnancy rate
Clinical pregnancy is defined as the presence of a gestational sac in the uterine cavity as indicated by ultrasound at 5-7 weeks of gestation
Measured: 6 months
Miscarriage rate
Miscarriage is defined as the pregnancy loss before 28 weeks of gestation
Measured: 6 months, if a participant is confirmed to get a clinically pregnancy during this period, the follow-up endpoint will be extended until there is a pregnancy outcome
Preterm birth rate
Preterm birth is defined as delivery at 28 to 37 weeks of gestation
Measured: 6 months, if a participant is confirmed to get a clinically pregnancy during this period, the follow-up endpoint will be extended until there is a pregnancy outcome
Live birth rate
Live birth is defined as delivery of any number of neonates born at 26 or more weeks' gestation with signs of life
Measured: 6 months, if a participant is confirmed to get a clinically pregnancy during this period, the follow-up endpoint will be extended until there is a pregnancy outcome
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2025
- Study startNov 2025 (estimated)
- Primary completionSep 2028 (estimated)
- Study completionSep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Abortion, MissedStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 159 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- The University of Science and Technology of China, Sir Run Run Shaw Hospital, Second Affiliated Hospital of Soochow University, The First Affiliated Hospital of Anhui Medical University, The First Affiliated Hospital of University of Science and Technology of China
- Responsible party
- Principal investigator, Yali Hu, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
- Investigators
- Yali Hu, Principal investigator, The Affiliated Drum Tower Hospital of Nanjing University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07230574
- Sponsor's protocol ID
- SC2025-0013-01
- Status last verified
- Nov 2025
- First submitted
- 13 Nov 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
- A Prospective, Multicenter, Randomized Controlled Clinical Study on Autologous Decidual-like NK Cells Therapy for Reproductive Failure Associated With Abnormal Uterine Natural Killer Cells
- ClinicalTrials.gov ID
- NCT07230574
- Acronym / sponsor ID
- SC2025-0013-01
- Keywords
- Recurrent Pregnancy Loss, Repeated Implantation Failure, Unexplained Infertility, Decidual Natural Killer Cells
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 159 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, Sir Run Run Shaw Hospital, Second Affiliated Hospital of Soochow University, The First Affiliated Hospital of Anhui Medical University, The First Affiliated Hospital of University of Science and Technology of China
- Study start
- Nov 2025 (estimated)
- Primary completion
- Sep 2028 (estimated)
- Study completion
- Sep 2028 (estimated)
- First posted
- 17 Nov 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 to verify the efficacy of in vitro induction of autologous decidual-like NK cells therapy for reproductive failure associated with uterine NK cells abnormalities.
Detailed description
Participants with reproductive failure and reproductive intentions will be recruited and screened. After obtaining their informed consent, menstrual blood analysis will be performed. Participants with menstrual blood NK cell abnormalities will be randomly assigned to either the NK cell perfusion group or control group in a ratio of 2:1. After completing two rounds of NK cell therapy, the NK cell perfusion group will enter the follow-up period, while the control group will not receive interventions after randomization and enter the follow-up period directly. The following information will be recorded for all participants who undergo menstrual blood NK cell analysis, including menstrual blood analysis results, attempts to conceive, and pregnancy outcomes during the follow-up period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NK cell perfusion group | Experimental | Biological: NK cell perfusion groupAccepting NK cell therapy |
| Control group | No intervention | –Not accepting NK cell therapy |
Who may qualify
- Ages
- 22 to 38 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Reproductive failure with abnormal endometrial natural killer (NK) cells in menstrual blood;
- With a clear intention to conceive;
- Normal ovarian function, or premature ovarian insufficiency with ≥2 high-quality cryopreserved embryos available for transfer;
- Endometrial thickness measured by transvaginal ultrasound during the periovulatory period ≥7 mm;
- Body mass index (BMI) between 18 kg/m² and 28 kg/m²;
Key exclusion criteria (8 listed)
- Use of progesterone receptor modulators;
- One of the couple's chromosomal karyotype abnormalities, with no euploid embryo identified via preimplantation genetic testing for aneuploidy;
- Severe endometriosis or adenomyosis, uterine fibroids affecting uterine cavity morphology, uterine malformations, intrauterine adhesions, or thin endometrium;
- Uncontrolled autoimmune or endocrine disorders;
- Contraindications to pregnancy;
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 |
|---|---|---|
| NK cell perfusion groupCompleting two rounds of NK cell therapy | Biological | NK cell perfusion group |
Primary outcome
Ongoing pregnancy rate
Time frame: 6 months, if a participant is confirmed to get a clinically pregnancy during this period, the follow-up endpoint will be extended until there is a pregnancy outcome
Ongoing pregnancy is defined as at least 12 weeks of gestation, with ultrasound indicating fetal cardiac activity and fetal size consistent with the gestational age
5 secondary outcomes
Improvement rate of NK cells
Time frame: 6 months
Clinical pregnancy rate
Time frame: 6 months
Miscarriage rate
Time frame: 6 months, if a participant is confirmed to get a clinically pregnancy during this period, the follow-up endpoint will be extended until there is a pregnancy outcome
Preterm birth rate
Time frame: 6 months, if a participant is confirmed to get a clinically pregnancy during this period, the follow-up endpoint will be extended until there is a pregnancy outcome
Live birth rate
Time frame: 6 months, if a participant is confirmed to get a clinically pregnancy during this period, the follow-up endpoint will be extended until there is a pregnancy outcome
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
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing NK cell perfusion group in people with Abortion, Missed and Infertility Unexplained, run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School.
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: opening soon, 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.
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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Ongoing pregnancy rate (time frame: 6 months, if a participant is confirmed to get a clinically pregnancy during this period, the follow-up endpoint will be extended until there is a pregnancy outcome). 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.