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Study aim
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Investigating the effectiveness of autologous Platelet-Rich Plasma (PRP) and Condition Medium of mesenchymal stem cells derived from the umbilical cord on the serum level of Anti Mullerian Hormone (AMH)
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Design
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Clinical trial with a control group, with parallel groups, no blinding, randomized, phase1,2 on 44 patients.
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Settings and conduct
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1. Patient identification
2. Preparation of umbilical cord from a newborn in Imam Khomeini Hospital, Sari
3. Preparation of Condition Medium of mesenchymal stem cells derived from the umbilical cord in the clean room of Sina Mehr Fajr Laboratory, Sari
4. Preparation of PRP in Imam Khomeini Hospital, Sari
5. Injection into the ovaries in the operating room of Imam Khomeini Hospital, Sari
6. Examination of serum AMH and AFC levels of patients before injection and 2, 6 and 14 weeks after injection
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Participants/Inclusion and exclusion criteria
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Inclusion criteria:
Women between 20 and 45 years of age, infertility for more than one year, having poor or diminished ovarian reserve, and one of the poor ovarian response criteria, which are:
Total AFC in both ovaries 7 or less on vaginal ultrasound, AMH less than 1.1 ng/ml, history of IVF with 3 or less eggs, signing informed consent form.
Exclusion criteria:
Pregnancy, history of IgA deficiency or currently, surgery leading to pelvic adhesions, taking anticoagulant drugs, mental illness with drug dependence, chronic malignancies or chronic pelvic pain, severe male factor infertility, drug addiction, endometriosis and abnormal uterine shape observed on hysterosalpingography, failure to sign the informed consent form.
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Intervention groups
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4 intervention groups: One group is injected with only autologous PRP, the other group with only Condition Medium, the next group with Condition Medium and PRP concurrently, and no injection for the control group.
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Main outcome variables
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Anti Mullerian Hormone, Antral Follicle Count