Diminished Ovarian Reserve Clinical Trial
— PRP4AGEOfficial title:
Study of Ovarian Function Following Intraovarian Injection of Platelet Rich Plasma (PRP) In Women With Evidence of Diminished Ovarian Function
The hypothesis of the study is that ovaries of women with a history of poor response to ovulation induction may benefit from exposure to growth factors known to be present in Platelet Rich Plasma (PRP). Since even ovaries from women with poor response still contain primordial follicles (which, however, no longer undergo recruitment), it is hoped that PRP injections into ovaries will activate follicular recruitment pathways and, subsequently, result in follicle growth. Should such growth be observed, follicles will be supported with routine daily gonadotropin stimulation until hCG trigger.
Status | Recruiting |
Enrollment | 66 |
Est. completion date | September 1, 2024 |
Est. primary completion date | June 1, 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 21 Years to 52 Years |
Eligibility | Inclusion Criteria: - Women with failure to respond well to ovulation induction by having fewer than 1 cleavage stage embryo in response to past ovulation induction who do not qualify for the PRP4POI study - Age 54 years and under. - FSH > 12 - AMH < 1.1 - -No Aspirin or Motrin for one week before treatment Exclusion Criteria: - Age > 54 years - Marked thrombocytopenia - Blood diseases - Hypofibrinogenemia - Hemodynamic instability - Anticoagulant or antiaggregant treatment - Oncological diseases (specially, skeletal system and blood) - Sepsis - Acute and chronic infectious diseases - Autoimmune diseases, for example, lupus erythematosus, etc. Relative contraindications for PRP - Chronic liver diseases in the exacerbation phase - Chronic intoxication against the background of long-term use of alcohol, addictive drugs, an administration of potent medications - Use of steroidal anti-inflammatory drugs in less than 2 days before drawing the blood, an injection of corticosteroids in little less than 2 weeks before the procedure - Pregnancy - Inflammatory skin diseases, chronic dermatosis in the exacerbation phase, for example, psoriasis, atopic eczema, etc. |
Country | Name | City | State |
---|---|---|---|
United States | Center For Human Reproduction | New York | New York |
Lead Sponsor | Collaborator |
---|---|
Center for Human Reproduction |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Emergence of new ovarian follicles with evidence of estradiol production | Emergence of new ovarian follicles greater than 4 mm in average diameter as measured using pelvic sonography with evidence of change estradiol serum estradiol levels as measured using a immuno assay. | Change from baseline to 12 weeks | |
Secondary | Change in serum AMH | Increase in serum AMH from baseline level as measured using an immuno assay | Change from baseline to 12 weeks | |
Secondary | Number of participants with retrieval of oocytes in an IVF cycle | Number of participants with retrieval of oocytes in an IVF cycle | 6 months | |
Secondary | Number of participants that establish a Clinical Pregnancy | Number of participants that establish a Clinical Pregnancy | 12 months |
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