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
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
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. |
Country | Name | City | State |
---|---|---|---|
Egypt | Benha University | Banha | Qalyubiya |
Lead Sponsor | Collaborator |
---|---|
Ahmed Saad | Hawaa Fertility Center |
Egypt,
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 |
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