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A randomized controlled trial of autologous peripheral blood mononuclear cells in the treatment of repeated implantation failure in patients with adenomyosis

A randomized controlled trial of autologous peripheral blood mononuclear cells in the treatment of repeated implantation failure in patients with adenomyosis

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500111043
Enrollment
Unknown
Registered
2025-10-24
Start date
2025-10-24
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adenomyosis

Interventions

Experimental Group:Intrauterine perfusion of autologous peripheral blood mononuclear cells (PBMCs)and HCG,PBMCs are isolated, in vitro, then perfused into the uterine cavity 3-5 days before embryo tra
Control group:Intrauterine perfusion of Human Chorionic Gonadotropin (HCG). 1ml (1000U) HCG solution is perfused into the uterine cavity 3-5 days before embryo transfer.

Sponsors

Shenzhen Maternity and Child Healthcare Hospital and Center, Southern Medical University, Shenzhen
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
20 Years to 45 Years

Inclusion criteria

Inclusion criteria: 1. Age between 20 and 45. 2. Consistent with the diagnosis of adenomyosis (confirmed by ultrasound and MRI) : The patient has typical symptoms of adenomyosis, such as dysmenorrhea (especially with increasing pain over time), menorrhagia, chronic pelvic pain, etc. The typical ultrasound features of adenomyosis were discovered by transvaginal ultrasound. It is recommended to adopt the 2018 federation international of gynecology and obstetrics. The FIGO authorized the morphological uterus sonographic assessment (MUSA) collaborative group to develop the criteria for diagnosing adenomyosis based on TVUS imaging. There are a total of 8 ultrasonic features, namely asymmetric thickening of the uterine myometrium; Cystic foci in the myometrium Island-like high-echo signal Fan-shaped shadow Linear or dot-like echoes under the endometrium; There are strip-shaped blood flow signals passing through the lesion. The shape of the junction band is irregular. The junction band is discontinuous. The evaluation of the junction band is recommended to be confirmed by combining 3D-TVUS examination. If two or more of the above signs are found in the ultrasound examination, adenomyosis is suspected. For cases where the results of ultrasound examination are uncertain or further diagnosis confirmation is needed, MRI should be used to conduct a detailed assessment of the anatomical structure of the uterus, such as the unevenness of the thickness of the uterine wall and the interior of the uterus Glandular invasion. 3. Patients with repeated embryo implantation failure (RIF) : Patients under 45 years old who have undergone IVF-ET and failed to achieve clinical pregnancy after at least 4 high-quality embryos were transplanted in at least 3 fresh or frozen cycles. (High-quality embryos: blastocysts (>=3BB) and third-day embryos (8>= cells, uniform blastomeres, fragmentation rate < 10)). 4. Male semen condition: Normal semen; Or if the male partner has mild to moderate asthenospermia or mild to moderate oligospermia, and the normal sperm morphology rate is between 1.5% and 4%, only patients undergoing conventional IVF treatment will be included.

Exclusion criteria

Exclusion criteria: 1. Exclude patients with severe oligospermia, severe asthenospermia, severe teratozoospermia (normal morphology rate <=1.5%), azoospermia in the male partner, and other patients requiring ICSI or TESA-ICSI. 2. Previous history of malignant tumors or major surgeries. 3. Autoimmune diseases or other diseases that affect the immune system. 4. Those with serious diseases who are not suitable for pregnancy. 5. Known to be allergic to therapeutic ingredients. 6. Either spouse has chromosomal abnormalities.

Design outcomes

Primary

MeasureTime frame
Clinical pregnancy rate;

Secondary

MeasureTime frame
Embryo implantation rate;Live birth rate;Miscarriage rate;Rate of symptom improvement in adenomyosis;Endometrial thickness;Distribution of lymphocyte subsets in the perfusion fluid;Immunoglobulin levels;Levels of cytokines in the perfusion fluid;

Countries

China

Contacts

Public ContactShuhua Wu

Shenzhen Maternity and Child Healthcare Hospital and Center Southern Medical University, Shenzhen

39028018@qq.com+86 135 1091 9152

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026