Clinical trial NCT04275700: Study of PRP in Women With Evidence of Diminished Ovarian Reserve
Official title: Study of Ovarian Function Following Intraovarian Injection of Platelet Rich Plasma (PRP) In Women With Evidence of Diminished Ovarian Function
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diminished Ovarian Reserve
Ovarian Failure
Keywords: Platelet Rich Plasma
Lead sponsor: Center for Human Reproduction
Sponsor class: OTHER
First posted: 2020-02-19
Enrollment: 80
Sex: FEMALE
Minimum age (years): 21
Maximum age (years): 52
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Each Ovary will be injected with A-PRP.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Emergence of new ovarian follicles with evidence of estradiol production
timeFrame: Change from baseline to 12 weeks
Secondary outcomes:
measure: Change in serum AMH
timeFrame: Change from baseline to 12 weeks
measure: Number of participants with retrieval of oocytes in an IVF cycle
timeFrame: 6 months
measure: Number of participants that establish a Clinical Pregnancy
timeFrame: 12 months
Other outcomes:
Locations:
city: New York
country: United States
facility: Center For Human Reproduction
state: New York
Study officials:
affiliation: Medical Director
name: Norbert Gleicher, MD
role: STUDY_CHAIR
References:
citation: Barad DH, Albertini DF, Molinari E, Gleicher N. Preliminary report of intraovarian injections of autologous platelet-rich plasma (PRP) in extremely poor prognosis patients with only oocyte donation as alternative: a prospective cohort study. Hum Reprod Open. 2022 Jun 28;2022(3):hoac027. doi: 10.1093/hropen/hoac027. eCollection 2022.