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Autologous Platelet-Rich Plasma Combined with Peripheral Blood Mononuclear Cells for Intraovarian Injection in Improving Ovarian Function in Older Women with Diminished Ovarian Reserve: A Multicenter Randomized Controlled Study Protocol

Autologous Platelet-Rich Plasma Combined with Peripheral Blood Mononuclear Cells for Intraovarian Injection in Improving Ovarian Function in Older Women with Diminished Ovarian Reserve: A Multicenter Randomized Controlled Study Protocol

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600117705
Enrollment
Unknown
Registered
2026-01-28
Start date
2026-02-01
Completion date
Unknown
Last updated
2026-02-02

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

Conditions

Advanced Age-Related Diminished Ovarian Reserve

Interventions

T1 group:Performed on an outpatient basis between days 3 and 7 of the menstrual cycle (patients are instructed to abstain from intercourse during this period). Under conscious sedation, a 35cm 19G sin
T2 group:Performed on an outpatient basis between days 3 and 7 of the menstrual cycle (patients are instructed to abstain from intercourse during this period). Under conscious sedation, a 35cm 19G sin
C1 group:Conventional assisted reproductive techniques are employed without prior intraovarian injection

Sponsors

Qinzhou Maternity and Child Healthcare Hospital
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
35 Years to 45 Years

Inclusion criteria

Inclusion criteria: 1. Participants must sign an informed consent form; 2. Age 35–45 years; 3. BMI 18.5–28.0 kg/m^2; 4. AMH level =10 IU/L, or transvaginal ultrasound showing a total bilateral ovarian antral follicle count (AFC) <=5; 5. Patients agree to enter an IVF-ET cycle within 3 months after PRP combined with PBMCs ovarian injection treatment.

Exclusion criteria

Exclusion criteria: 1. Ovarian failure caused by non-natural factors such as chromosomal karyotype abnormalities, history of oophorectomy/partial oophorectomy, pelvic radiotherapy/chemotherapy, or autoimmune oophoritis; 2. Indications for preimplantation genetic testing (PGT); 3. Presence of untreated hydrosalpinx, known moderate or severe endometriosis, history of recurrent miscarriage, endometrial lesions, uterine malformations, or other diseases that may affect IVF-ET success; 4. Poorly controlled endocrine or metabolic disorders, such as pituitary, adrenal, pancreatic, liver, or kidney diseases, uncontrolled thyroid diseases, diabetes (HbA1c >7.0%), severe obesity or emaciation; 5. Factors affecting the safety of PRP/PBMCs treatment, such as platelet function disorders, coagulation abnormalities, active infections, history of malignancy, severe active autoimmune diseases, or allergies to related preparations; 6. Receiving targeted treatments within 3–6 months prior to enrollment that may interfere with efficacy evaluation, such as hormone replacement cycles, antioxidant therapy, IVF cycles, or other ovarian regeneration treatments; 7. Severe male factor infertility without planned use of ICSI or donor sperm; 8. Other factors deemed by the investigator to make participation inappropriate, or contraindications to fertility treatment/pregnancy.

Design outcomes

Primary

MeasureTime frame
Cumulative Live Birth Rate;

Secondary

MeasureTime frame
LH Elevation / Spontaneous Ovulation Rate;Number of Oocytes Retrieved;Number of Mature Oocytes;Number of Fertilized Oocytes;Number of Cleavage-Stage Embryos;Number of High-Quality Embryos;Blastocyst Formation Rate;Number of Cryopreserved Embryos/Blastocysts;Full Embryo Cryopreservation Rate;ß-hCG Positivity Rate;Clinical Pregnancy Rate;Ongoing Pregnancy Rate (Pregnancy =10 weeks);

Countries

China

Contacts

Public ContactHongbo Wu

Qinzhou Maternity and Child Healthcare Hospital

wuhongbo20212021@163.com+86 777 239 1663

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 7, 2026