Set up of new stem cell therapy method for infertile women with diminished ovarian reserve (DOR) by using autologous menstrual blood-derived stem cells and plasma rich platelet (PRP)

Evaluation the effect of mesenchymal stem cells derived from menstrual blood and autologous platelet-rich plasma (PRP) on ovarian reserves and pregnancy

Clinical trial with a control group, with parallel groups, without blinding, randomized, phase1,2 on 40 patients. The selection of the group type for each person through random allocation 2 statistical software.

1. Isolation and culture of mesenchymal stem cells from menstrual blood of DOR patients in Clean room of Sinai Mehr Fajr Laboratory in Sari 2. Flow cytometry 4. Preparation of PRP 5. Patient selection 6. Check the serum level of AMH, FSH, estradiol and AFC two weeks before and after injection. Registration of embryo quality and pregnancy success rate after injection in Imam Khomeini Hospital, Sari

Inclusion criteria : 20 to 45 years old with DOR, history of infertility for more than one year, rejection of at least one IVF, AFC of two ovaries less than 7 or serum level of AMH less than 1.1 ng/mL, with few egg count or low quality embryos in IVF cycle. Absence of ovulation or amenorrhea (at least three months). Exclusion criteria: Pregnancy, IgA deficiency, secondary ovarian failure caused by sex chromosomes, use of anticoagulants, history of mental illnesses with drug addiction, surgery leading to pelvic adhesions, malignancy or chronic pelvic pain, infertility due to severe male factor, abnormal uterine shape and endometrium caused by abscess.

4 intervention groups.One group is injected with autologous menstrual blood-derived stem cells, the other group is injected with autologous PRP, the next group is injected with both stem cells and PRP, and nothing is injected into the control group.

AMH; AFC; FSH; Estradiol; Embryo quality; Pregnancy success rate

To allocate the samples to each group, the random block method will be used. For this purpose, patients will receive number 1 to 40 according to their arrival. The randomization unit will be individually and by number with blocks of 4 people. The selection of the group type for each person will be done through random allocation 2 statistical software. In order to make a random sequence, A, B, C, D codes will be generated from the software, and each code will be considered for one group. Finally, the codes will be placed in the sealed envelope and the number of each patient will be written on the envelope. As each patient enters, the doctor will open the envelope and apply the desired treatment.