Health TrialsbyHealthPanel

Autologous Decidual-like Natural Killer Cells Therapy for Reproductive Failure

ConditionsAbortion, MissedInfertility UnexplainedReproductive Disorder
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexFemale
Age22-38
SponsorThe Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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;

Disqualifiers

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;

Trial design

Design model

Parallel

Treatments tested in this trial

  • NK cell perfusion group

    Biological/Vaccine

    Completing two rounds of NK cell therapy

Treatment groups

159 Participants
are divided into 2 treatment groups
Group A: NK cell perfusion groupExperimental treatment 1 intervention
Group B: Control groupNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

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

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

Secondary outcomes

1

Improvement rate of NK cells

Improvement rate of NK cells in menstrual blood analysis after intrauterine perfusion of autologous decidual-like NK cells

Time frame
6 months
2

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

Time frame
6 months
3

Miscarriage rate

Miscarriage is defined as the pregnancy loss before 28 weeks of gestation

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
4

Preterm birth rate

Preterm birth is defined as delivery at 28 to 37 weeks of gestation

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

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Lead sponsor

The University of Science and Technology of China

Collaborator

Sir Run Run Shaw Hospital

Collaborator

Second Affiliated Hospital of Soochow University

Collaborator

The First Affiliated Hospital of Anhui Medical University

Collaborator

The First Affiliated Hospital of University of Science and Technology of China

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: