Ovarian Injection of PRP (Platelet -Rich Plasma) Vs Normal Saline in Premature Ovarian Insufficiency
Study Details
Study Description
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
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1/Phase 2 |
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 Finally, a blood sample will be withdrawn for the following lab.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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 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. |
Biological: platelet rich plasma
blood will be withdrawn from the patient then separation of the platelet rich layer and then injection in the ovary
|
| 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. |
Drug: Normal saline
0.9% normal saline will be injected in each ovary
Other Names:
|
Outcome Measures
Primary Outcome Measures
- FSH hormonal changes [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 [3rd day of the 3rd menstrual cycle after the procedure]
monitor the number of antral follicles.
- clinical follow up [3rd day of the 3rd menstrual cycle after the procedure]
changes in the menstrual cycle by history taking & questionnaire
- LH hormonal changes [3rd day of the 3rd menstrual cycle after the procedure]
serum LH at day 3 of the menstrual cycle
- E2 hormonal changes [3rd day of the 3rd menstrual cycle after the procedure]
serum E2 at day 3 of the menstrual cycle
- AMH hormonal changes [3rd day of the 3rd menstrual cycle after the procedure]
serum AMH
Eligibility Criteria
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Benha University | Banhā | Qalyubiya | Egypt | 13512 |
Sponsors and Collaborators
- Ahmed Saad
- Hawaa Fertility Center
Investigators
- Study Director: Mohamed F Elsherbiny, phd.MD, Professor of OB & GYN
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- Hawaa-9