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

Premature Ovarian Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04922398
• Other study ID #: Hawaa-9
• Status: Not yet recruiting
• Phase: Phase 1/Phase 2
• Start date: June 20, 2021
• Est. completion date: December 30, 2021

Study information

• Verified date: June 2021
• Source: Benha University
• Contact: Ahmed S Saad, phd, MD
• Phone: 01221709989
• Email: drahmedsaad[@]live.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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 Finally, a blood sample will be withdrawn for the following lab.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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: December 30, 2021
• Est. primary completion date: December 1, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years to 42 Years

Eligibility

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 10?/µL were excluded from the study.

Related Conditions & MeSH terms

• Menopause, Premature
• Premature Birth
• Premature Ovarian Failure
• Primary Ovarian Insufficiency

Intervention

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

Locations

Country	Name	City	State
Egypt	Benha University	Banha	Qalyubiya

Sponsors (2)

Lead Sponsor	Collaborator
Ahmed Saad	Hawaa Fertility Center

Country where clinical trial is conducted

Egypt, 

Outcome

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