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Could your own cells help you get pregnant? new trial explores NK cell therapy for infertility

NCT ID NCT06821685

Disease control Sponsor: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This early-phase study tests whether a woman's own natural killer cells, processed in a lab and infused into her uterus, can improve uterine immune function and lead to successful pregnancy. It includes 14 women with a history of recurrent miscarriage, failed IVF, unexplained infertility, or severe pregnancy complications linked to abnormal uterine NK cells. The goal is to see if the treatment is safe and can restore normal immune activity in the womb.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 14 people

The number the study aims to enrol. It can still change while the study runs.

Started

Feb 2025

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

22 to 40 years

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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; Exclusion Criteria: * 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.

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Conditions

The condition(s) this trial relates to.

fetal growth restriction habitual spontaneous abortion infertility disorder preeclampsia

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Abortion, habitual Embryo implantation Infertility unexplained Pre-eclampsia

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

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Contacts and locations

Locations

  • The Affiliated Drum Tower Hospital of Nanjing University

    RECRUITING

    Nanjing, Jiangsu, 210006, China

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