Clinical trial NCT04922398: Ovarian Injection of PRP (Platelet -Rich Plasma) Vs Normal Saline in Premature Ovarian Insufficiency
Official title: Ovarian Injection of PRP (Platelet -Rich Plasma) Vs Normal Saline in Premature Ovarian Insufficiency: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Premature Ovarian Failure
Keywords: premature ovarian failure
poor responders
poor ovarian reserve
PRP
Lead sponsor: Benha University
Sponsor class: OTHER
Collaborators: name: Hawaa Fertility Center
First posted: 2021-06-10
Enrollment: 60
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 42
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 60 patients with premature ovarian failure will be divided into 2 groups. 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.
Primary purpose: TREATMENT

Brief 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

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 Finally, a blood sample will be withdrawn for the following lab.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

Eligibility criteria: 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.

Primary outcomes:
measure: FSH hormonal changes
timeFrame: 3rd day of the 3rd menstrual cycle after the procedure
measure: vaginal ultrasound monitoring of the ovaries
timeFrame: 3rd day of the 3rd menstrual cycle after the procedure
measure: clinical follow up
timeFrame: 3rd day of the 3rd menstrual cycle after the procedure
measure: LH hormonal changes
timeFrame: 3rd day of the 3rd menstrual cycle after the procedure
measure: E2 hormonal changes
timeFrame: 3rd day of the 3rd menstrual cycle after the procedure
measure: AMH hormonal changes
timeFrame: 3rd day of the 3rd menstrual cycle after the procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Banhā
country: Egypt
facility: Benha University
state: Qalyubiya
Study officials:
affiliation: Professor of OB & GYN
name: Mohamed F Elsherbiny, phd.MD
role: STUDY_DIRECTOR
References: