Single Center, Prospective Controlled Pilot Study of the OvaPrime Procedure

Inclusion Criteria

• •1. Subjects who are diagnosed with EITHER POI or POR as defined below:
• •* POI subjects who are:
• •* \< 40 years of age
• •* have non-detectable AMH
• •* FSH \>15.0 mIU/ml and/or symptoms of menopause
• •* POR (based on European Society of Human Reproduction and Embryology (ESHRE) guidelines must have two of the following:
• •* 40 years of age
• •* A previous IVF cycle with \< 3 oocytes with a standard of care controlled ovarian hyperstimulation protocol
• •* An abnormal ovarian reserve test defined as:
• •1. AFC \< 5 - 7 follicles or
• •2. AMH \< 0.5 - 1.1 ng/ml or
• •3. Highest ever baseline FSH \> 15.0 ml U/ml
• •2. Subject must have both ovaries.
• •3. Subject agrees to participate in main study follow up as well as Long Term Follow-up (LTFU) sub-study
• •4. Subject's male partner or sperm donor source must meet the following requirements:
• •* Semen must be an ejaculate (not surgically derived, epididymal, testicular, electro- ejaculated sperm), collected by ejaculation.
• •* Male partner's testes must not have been exposed to chemotherapy.
• •* Semen must have some morphologically normal spermatozoa according to the World Health Organization (see table below) and adequate concentration with some motile spermatozoa for insemination of all oocytes by intra-cytoplasmic sperm injection (ICSI).
• •WHO Semen variable 2010 Volume (mL) 1.5 Concentration (106 mL-1) 15 Total sperm number (106/ejaculate) 39 Motility (% motile) 40 (a + b + c) Forward progression 32 (a + b) Morphology (% normal) 4 Viability/vitality (% live) 58 White blood cells (106 mL-1) \< 1.0
• •5. Partner must also agree to all research study requirements including follow up (including main study as well as LTFU sub-study) of offspring and sign consent form (not applicable in the case of a woman using sperm donation).