Ovarian Function Following Intraovarian Injection of PRP (PRP4POA)

Center for Human Reproduction

Status: Active, not recruiting

Conditions: Diminished Ovarian Reserve; Diminished Ovarian Reserve Due to Advanced Maternal Age

Treatments: Procedure: PRP - Platelet Rich Plasma; Procedure: PPP - Platelet Poor Plasma

Study type: Interventional

Funder types: Other

Identifiers

NCT04278313

02102020-0

Details and patient eligibility

About

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).

Full 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.

Enrollment: 90 estimated patients

Sex: Female

Ages: 21 to 44 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Quadruple Blind

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90 participants in 2 patient groups, including a placebo group

PRP group

Experimental group

Description:

Platelet RICH Plasma prepared using RegenLab FDA approved device.

Treatment:

Procedure: PRP - Platelet Rich Plasma

PPP group

Placebo Comparator group

Description:

Platelet POOR Plasma prepared using RegenLab FDA approved device.

Treatment:

Procedure: PPP - Platelet Poor Plasma