Autologous Decidual-like Natural Killer Cells Therapy for Reproductive Failure

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE2

Total Enrollment

159 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-11-30

Study Completion Date

2028-09-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Abortion, Missed Infertility Unexplained Reproductive Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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NK cell perfusion group

Accepting NK cell therapy

Group Type EXPERIMENTAL

NK cell perfusion group

Intervention Type BIOLOGICAL

Completing two rounds of NK cell therapy

Control group

Not accepting NK cell therapy

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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NK cell perfusion group

Completing two rounds of NK cell therapy

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* 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.

Minimum Eligible Age

22 Years

Maximum Eligible Age

38 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No