Menopause Clinical Trial
Official title:
Platelet Rich Plasma Ovarian in Vitro Activation and Stem Cells Transplantation In Women With Ovarian Failure
SEGOVA procedure includes - Stem cell therapy, G - Growth factor Platelet Plasma Rich therapy and in Vitro Activation of the ovaries.
The current study seeks to demonstrate how integrative ovarian rejuvenation program called
SEGOVA influence the restoration of hormone stability and increase in the number of follicles
in ovarian failure patients. The recruitment of patients and data collection would be
performed at three sites: The Special Hospital Jevremova Belgrade, Saint James Hospital
Malta, and Remedica Skopje Hospital, Macedonia. A 50-100 of Infertile women with ovarian
failure will be included in the period between July 2019 - December 2021. The patients would
be coded when entering the program, and all personal information would be protected.
Information about medical treatment and background will be held on both paper and electronic
case report forms.The result of the procedure will be maintained in the research database
with blinding to clinical physician that will perform post procedure follow-up of those
patients. In case of a complication, possibly related to treatment, the case will be
unblinded.
The first day of procedure, autologous platelet rich plasma (PRP) is obtained from 100-120 mL
of whole blood. After separation 4 mL of PRP is obtained. Concentration of platelets is
optimised on 6-8x baseline and 2-3x leucocytes baseline. For activation of PRP autologous
thrombin is used in ratio 1:10.
On the same day the laparoscopic cortical resection of the ovary is performed in standard
technique. Ovarian cortex sample is minced in a petri dish.The volume of activated PRP (4 mL)
is mixed with ovarian fragments and incubated for the next 48h at 37℃ and 5% CO2. After 48h,
the bone marrow sampling from tibia under general anesthesia is performed to obtain bone
marrow. After centrifugation the Bone Marrow Aspirate Concentrate (BMAC) with nucleated cells
is obtained (3 +/- 1,5 mL).
Finally, after the 48h has passed from ovarian cortex tissue incubation, fragmented tissue of
the ovary with 4 mL of PRP will be injected together with 3 +/- 1.5 mL BMAC into the
subcortical region of the both ovaries as transvaginal ultra sound guided injection.
After the procedure, during one year follow up, hormone levels of follicle stimulating
hormone (FSH), luteinizing hormone (LH),estradiol (E2), progesterone (PG) and anti-mullerian
hormone (AMH) would be measured and the follicle numbers would be monitored to provide
insight regarding the ovarian function.To investigate the changes in hormone levels,
comparisons of the levels detected prior to the intervention, and 3, 6 and 12 months
post-intervention, would be performed using Wilcoxon's rank test. Descriptive statistics will
be provided for each variable as mean or median number, frequency, percentage, table or
graph.
In patients with oocytes retrieved after SEGOVA procedure, standard In Vitro Fertilization
protocol would be performed,and fertilization, cleavage and clinical pregnancy rates will be
monitored.
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