Ovarian Injection of PRP (Platelet -Rich Plasma) Vs Normal Saline in Premature Ovarian Insufficiency

Overview

60 cases with premature ovarian insufficiency will be randomized to either receive PRP or saline injection in their ovaries. Then follow up by hormonal & ultrasound & clinically to monitor any changes

Full Title of Study: “Ovarian Injection of PRP (Platelet -Rich Plasma) Vs Normal Saline in Premature Ovarian Insufficiency: A Randomized Controlled Trial”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Participant, Outcomes Assessor)
  • Study Primary Completion Date: December 1, 2021

Detailed Description

In this pilot study, 60 patients will be included. All patients will have a premature ovarian insufficiency (PORs) who meet at least two of the following three Bologna criteria. The following data will be registered for all the cases: age, weight, height, menstrual history, previous pregnancies and their outcome, no. of living children and age of the youngest, history symptoms, married for how long, infertility duration and whether primary or secondary. Estimation of Antral Follicle Count (AFC) will be done for all the patients by transvaginal ultrasound (TVUS). Finally, a blood sample will be withdrawn for the following lab. Investigations: FSH, LH, E2, AMH, TSH, Prolactin before inclusion of the patients in the study. A written consent form will be signed by all patients after complete explanation of the procedures and the expectations of the trial. Patients will be randomized into 2 groups (A& B). All will undergo a transvaginal intervention through an ovum pickup needle 17 G for the procedure. The group A consists of 30 patients, who will receive a PRP (autologous platelet-rich plasma injection) with activation with calcium chloride. The group B consists of 30 patients, who will receive a normal saline inj. 0.9% Nacl. Sample preparation of the PRP: According to the classification proposed by Ehrenfest, 4 different types of PRP are defined, depending on the content of cells and the presence of fibrin. In regards to the Classification of PRP in this case study, it is used as a commercial type of PRP with the lower concentration (2.5 x 3 times) system, Ycellbio PRP. The process will be carried out under strict aseptic conditions as well as optimum temperature regulations, i.e., 21-24°C. PRP will be prepared according to the manufacturer's guidelines. Draw 1 CC anticoagulant (sodium citrate) into a 20 CC syringe. Coat the inside walls of the syringe with the drawn anticoagulant. Then draw 14 CC blood under complete aseptic condition into a 20 CC syringe. Swing the syringe slowly to mix blood and anticoagulant well. Inject the blood slowly into the Ycellbio tube. Straighten the tube when the blood reaches the Y-funnel. Inject the blood into the Ycellbiotube to the appropriate level as indicated by the lines. Close the Ycellbio tube with silicon stopper using a forceps. Centrifuge at 3500 RPM at time 5 min. After the 5 min. spin, the Buffy coat is well visible. Twist the controller to adjust the height of buffy coat to the marked line. Twist the controller to adjust the height of buffy coat to the marked line. Prepare a 18 G ½ needle and a 3 CC syringe for PRP harvest. Open the silicone stopper using an alcohol soaked cotton. Extract 2.0 CC PRP while slowly swirling the needle in the area of the PRP into a 3 CC syringe. The same process is done for another 3 blood samples to have a total of 8 ml PRP to be used for both ovaries. In the last step, the volume immediately above the erythrocyte layer will be collected. Calcium gluconate in conc. 1:9 will be used as an activator. After activation, in a period less than 2 min, approximately 4 ml of the PRP will be injected into each ovary by TVUS. Monitoring & follow up: The changes in the hormones at day 3 of the menstrual cycle: FSH, LH, estradiol, AMH will be closely monitored,after the application of the procedure in each group after 3 months. The investigators will also monitor the number of antral follicles & changes in the menstrual cycles & spontaneous ovulation before and after 3 months.

Interventions

  • Biological: platelet rich plasma
    • blood will be withdrawn from the patient then separation of the platelet rich layer and then injection in the ovary
  • Drug: Normal saline
    • 0.9% normal saline will be injected in each ovary

Arms, Groups and Cohorts

  • Active Comparator: Group A: PRP group
    • Preparation of PRP sample fro the patient own blood then the volume immediately above the erythrocyte layer was collected. Calcium gluconate in conc. 1:9 will be used as an activator. After activation, in a period less than 2 min, approximately 4 ml of the PRP will be injected into each ovary by TVUS.
  • Placebo Comparator: Group B: saline group
    • consists of 30 patients, who will receive 4 ml of a normal saline inj. 0.9% Nacl. then injected into each ovary by TVUS.

Clinical Trial Outcome Measures

Primary Measures

  • FSH hormonal changes
    • Time Frame: 3rd day of the 3rd menstrual cycle after the procedure
    • The changes in the hormones at day 3 of the menstrual cycle: FSH monitored
  • vaginal ultrasound monitoring of the ovaries
    • Time Frame: 3rd day of the 3rd menstrual cycle after the procedure
    • monitor the number of antral follicles.
  • clinical follow up
    • Time Frame: 3rd day of the 3rd menstrual cycle after the procedure
    • changes in the menstrual cycle by history taking & questionnaire
  • LH hormonal changes
    • Time Frame: 3rd day of the 3rd menstrual cycle after the procedure
    • serum LH at day 3 of the menstrual cycle
  • E2 hormonal changes
    • Time Frame: 3rd day of the 3rd menstrual cycle after the procedure
    • serum E2 at day 3 of the menstrual cycle
  • AMH hormonal changes
    • Time Frame: 3rd day of the 3rd menstrual cycle after the procedure
    • serum AMH

Participating in This Clinical Trial

Inclusion Criteria

  • PORs who meet at least two of the following three Bologna criteria – AMH: 0.1-1 ng/ml. Exclusion Criteria:

  • ovarian insufficiency due to gonadal dysgenesis and - – chromosomal abnormalities, – immunoglobulin A deficiency, – the use of anticoagulants, – psychotropic medicaments, – psychiatric disorders, – carcinomas or – a history of chronic pelvic pain. – Women with present infection, – haemoglobin lower than 11 g/L or – platelets lower than 150 x 10ʒ/μL were excluded from the study.

Gender Eligibility: Female

only in female patients

Minimum Age: 20 Years

Maximum Age: 42 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Ahmed Saad
  • Collaborator
    • Hawaa Fertility Center
  • Provider of Information About this Clinical Study
    • Sponsor-Investigator: Ahmed Saad, Assistant professor of obstetrics & gynecology – Benha University
  • Overall Official(s)
    • Mohamed F Elsherbiny, phd.MD, Study Director, Professor of OB & GYN
  • Overall Contact(s)
    • Ahmed S Saad, phd, MD, 01221709989, drahmedsaad@live.com

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