Diminished Ovarian Reserve, Diminished Ovarian Reserve Due to Advanced Maternal Age
Conditions
Keywords
Infertility - Ovarian dysfunuction, Diminished Ovarian Reserve, Premature Ovarian Aging (POA)
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.
Interventions
PROCEDUREPRP - Platelet Rich Plasma
Using a sterile vacutainer technique two 8 ml samples of whole blood is drawn into two Regen Lab A-PRP vacutainers with gel separator and citrate. Invert the tube to mix with citrate. The whole blood undergoes two centrifugations, once for 3 minutes and again for 5 minutes. Using a 20-gauge 6-inch spinal needle 2 ml of Platelet POOR Plasma will be drawn off the supernatant from each tube to leave 2.5 ml of Platelet Rich Plasma in the tube. The tube is inverted several times to suspend the platelet pellet. The prepared plasma labeled with the participants name and randomization code will be transported to the procedure room.
PROCEDUREPPP - Platelet Poor Plasma
Using a sterile vacutainer technique two 8 ml samples of whole blood is drawn into two Regen Lab A-PRP vacutainers with gel separator and citrate. Invert the tube to mix with citrate. The whole blood undergoes two centrifugations, once for 3 minutes and again for 5 minutes. Using a 20-gauge 6-inch spinal needle 2 ml of Platelet POOR Plasma will be drawn off the supernatant from each tube. The prepared plasma will be transported to the procedure room. The prepared plasma labeled with the participants name and randomization code will be transported to the procedure room.
Sponsors
Center for Human Reproduction
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
Participants will be randomly assigned to treatment with either Platelet Rich Plasma (PRP) or Platelet Poor Plasma (PPP)
Eligibility
Sex/Gender
FEMALE
Age
21 Years to 44 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Embryo Transfer | 6 weeks | Number of participants with at least one day-3 embryo 8-cell with less than 5% fragmentation in an IVF cycle |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Antral Follicle Count | 4 weeks | Number of Antral Follicles determined by pelvic sonogram on day 2 or 3 of menses |
| Embryos Produced | 6 weeks | Mean number of day-3 embryo 8-cell with less than 5% fragmentation produced |
| AMH | 4 weeks | Serum concentration of Anti Mullerian Hormone |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORDavid H Barad, MD
Center for Human Reproduction
Outcome results
None listed