Diminished Ovarian Reserve, Ovarian Failure
Conditions
Keywords
Platelet Rich Plasma
Brief summary
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.
Detailed description
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 PRP. Autologous Platelet Rich Plasma (A-PRP) is plasma with a concentration of platelets above the blood baseline. A-PRP is developed from autologous blood. Within A-PRP, the concentration of platelets delivers an increased number of growth factors. In this study A-PRP will be prepared using Regen Lab PRP Kit which is approved by US-FDA for preparation of PRP. PRP is becoming widely used in a variety of medical procedures seeking tissue remodeling and/or healing as an intervention. To date, applications in orthopedics, wound healing, dermatology and plastic surgery have gained general acceptance, primarily as the role of platelets and their activation in tissue repair and recovery has become better understood at a cellular and molecular level. This knowledge base provides a foundation for the present study because of the ready availability of FDA-approved kits for autologous PRP preparations and the recognition that the aging ovary acquires tissue pathologies in the form of wound healing and fibrosis as a result of repeat ovulations over the reproductive lifespan of women. Since PRP is an autologous blood product, and is widely used via injection into various organs and tissues, safety concerns are minimal. This study will involve only adult women with a diagnosis of diminished ovarian reserve. All consenting participants will receive injections of autologous Platelet RIch Plasma (A-PRP) in both ovaries under ultrasound guidance performed after induction of IV sedation. Assumption of this study is that in women with previous poor response to ovulation induction will show limited follicle growth. The study will try to estimate effect of PRP on this condition by comparing post-PRP response to the previous response. The investigators recognize that there will be a possibility of apparent response based on regression to the mean. The investigators expect that study of fifty patients should be enough to determine if there is a potential clinical effect and to allow estimation of that effect for power calculations for future studies.
Interventions
PROCEDUREA-PRP
The cortex of each ovary will be injected with autologous platelet rich plasma. Up to seven different sites will be injected under ultrasound guidance. The patient will be under IV sedation.
Sponsors
Center for Human Reproduction
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Masking description
No Masking
Intervention model description
Each Ovary will be injected with A-PRP.
Eligibility
Sex/Gender
FEMALE
Age
21 Years to 52 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Emergence of new ovarian follicles with evidence of estradiol production | Change from baseline to 12 weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in serum AMH | Change from baseline to 12 weeks | Increase in serum AMH from baseline level as measured using an immuno assay |
| Number of participants with retrieval of oocytes in an IVF cycle | 6 months | Number of participants with retrieval of oocytes in an IVF cycle |
| Number of participants that establish a Clinical Pregnancy | 12 months | Number of participants that establish a Clinical Pregnancy |
Countries
United States
Outcome results
None listed