Using natural killer cells from patients to improve fertility and pregnancy outcomes

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study explores the effectiveness of autologous decidual-like natural killer (NK) cells therapy in patients experiencing infertility or adverse pregnancy outcomes. Patients with abnormal uterine NK cell function will undergo menstrual blood analysis and, if eligible, will have their peripheral blood collected to isolate and culture NK cells. These cells will then be infused into the uterus, with continuous monitoring of NK cell function and subsequent pregnancy attempts over a six-month period. If necessary, patients may receive up to two treatments to enhance NK cell function.

Why it matters

Who can join: the full rules

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.

Where it's running

• The Affiliated Drum Tower Hospital of Nanjing University
  Nanjing, Jiangsu, China Recruiting

Study contacts

• Principal investigator: Yali Hu — The Affiliated Drum Tower Hospital of Nanjing University
• Study coordinator: Yali Hu
• Email: glyyhuyali@163.com
• Phone: 86-025-83106666

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.