Single Center, Prospective Controlled Pilot Study of the OvaPrime Procedure

Launched by OVASCIENCE, INC. · Jan 11, 2017

Keywords

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Gender

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Eligibility criteria

• 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).
• Exclusion Criteria:
• • 1. Subject with a diagnosis of POI who is ≥ 40 years of age or \< 21 years of age at the time of the OvaPrime procedure
• • 2. Subject with onset of POI \< 18 years of age
• • 3. Subject with a diagnosis of POR who is \> 45 years of age at the time of the OvaPrime procedure
• • 4. Subject has had any prior surgery/medical condition that would prevent direct access to the ovaries (e.g., pelvic adhesions, tubo- ovarian adhesions location/displacement of the ovary(ies) or high body mass index (BMI)).
• • 5. Subject has severe (stage IV) endometriosis or presence of an endometrioma
• • 6. Subject has a unilateral or bilateral untreated hydrosalpinx
• • 7. Subject has participated in the active phase of another investigational trial within the previous 30 days
• • 8. Subject has a history of prior chemotherapy or radiation therapy to the pelvis
• • 9. Subjects and/or partner (supplying sperm) with known karyotypic abnormalities 10. Subjects with POI who have FMR1 premutations or an FMRI mutation
• • 11. Subjects who are positive for the hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) and human immunodeficiency virus (HIV).