Clinical trial NCT04278313: Ovarian Function Following Intraovarian Injection of PRP
Official title: Randomized Controlled Trial of Ovarian Function Following Intraovarian Injection of Platelet Rich Plasma for Women With Ovarian Aging
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Diminished Ovarian Reserve
Diminished Ovarian Reserve Due to Advanced Maternal Age
Keywords: Infertility - Ovarian dysfunuction
Diminished Ovarian Reserve
Premature Ovarian Aging (POA)
Lead sponsor: Center for Human Reproduction
Sponsor class: OTHER
First posted: 2020-02-20
Enrollment: 90
Sex: FEMALE
Minimum age (years): 21
Maximum age (years): 44
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: Participants will be randomly assigned to treatment with either Platelet Rich Plasma (PRP) or Platelet Poor Plasma (PPP)
Primary purpose: TREATMENT

Brief summary: Consenting women with evidence of poor ovarian reserve will be randomly assigned to treatment with either Platelet Rich Plasma (PRP) or Platelet Poor Plasma (PPP).

Detailed description: As women age oocytes are gradually depleted with a consequent progressive loss of ovarian function and fertility. When a woman's follicle cohort falls below a critical level, she enters a transitional time of diminished ovarian reserve known as ovarian aging. Recently the use of autologous platelet-rich plasma (A-PRP) has been proposed as an additional strategy for improving ovarian function. A-PRP is prepared from autologous blood using an FDA approved device. The rationale for the use of PRP is that it contains growth factors which stimulate cellular anabolism, inflammatory modulators that create an anti-inflammatory effect and fibrinogen which acts as a scaffold for regenerating tissue. The investigators hypothesize that the growth factors present in PRP may have a beneficial effect promoting growth and recruitment of antral follicles. The investigators will recruit a prospective cohort of 90 patients with evidence of Premature Ovarian Aging/DOR. Women invited to participate in this RCT will have FSH above 12 and AMH below 1.0 ng/mL respectively and will have had fewer than 6 oocytes retrieved in a previous ovulation attempt. Consenting participants in this trial will be randomized in a doubly blind fashion to two groups. One will receive Platelet Rich Plasma (PRP) and the other will receive Platelet Poor Plasma (PPP). Women assigned to PPP will be offerred PRP in a future cycle if they so desire.

Eligibility criteria: Inclusion Criteria:

* fewer than 6 oocytes in response to past ovulation induction
* desire to establish a pregnancy using IVF
* Age 44 years and under.
* FSH \> 12
* AMH \< 1.0
* No Aspirin or Motrin for one week before treatment

Exclusion Criteria:

* Age \> 45 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.

Primary outcomes:
measure: Embryo Transfer
timeFrame: 6 weeks
Secondary outcomes:
measure: Embryos Produced
timeFrame: 6 weeks
measure: AMH
timeFrame: 4 weeks
measure: Antral Follicle Count
timeFrame: 4 weeks
Other outcomes:
measure: Pregnancy
timeFrame: 8 weeks
Locations:
city: New York
country: United States
facility: Center for Human Reproduction
state: New York
Study officials:
affiliation: Center for Human Reproduction
name: David H Barad, MD
role: PRINCIPAL_INVESTIGATOR
References: