New Hope Fertility Center
This prospective study compares two approaches to obtaining mature oocytes for fertility treatment within the same participant. Immature oocytes are first retrieved from the right ovary and matured in the laboratory using a two-step biphasic capacitation in vitro maturation method (CAPA-IVM). Beginning on Day 5 of the same menstrual cycle, the left ovary undergoes minimal controlled ovarian stimulation followed by routine oocyte retrieval and IVF/ICSI. The primary objective is to evaluate the maturation of CAPA-IVM oocytes to the metaphase II (MII) stage and compare reproductive laboratory outcomes between the CAPA-IVM and minimal-stimulation OS-IVF approaches. Secondary outcomes include fertilization, embryo development, blastocyst formation, embryo quality, pregnancy and live birth outcomes, and safety.
This is a prospective, within-patient comparative study in women undergoing fertility treatment. Each participant serves as her own internal control. At the Day 3 baseline visit, the right ovary is assigned to the CAPA-IVM approach and the left ovary is assigned to minimal controlled ovarian stimulation followed by IVF/ICSI. Both approaches are performed within the same menstrual cycle. For the CAPA-IVM arm, immature oocytes are retrieved from the right ovary beginning on or after menstrual cycle Day 3, before ovarian stimulation is initiated. The right ovary is not stimulated and does not re…
Inclusion Criteria: * Female, age 18 to 38 years. * Undergoing assisted reproductive treatment for infertility. * Both ovaries present and anatomically suitable for oocyte retrieval, with no prior oophorectomy. * Adequate ovarian reserve for study participation, including AMH greater than 0.5 ng/mL and antral follicle count greater than 6 per ovary. * Both ovaries considered suitable for their assigned study procedures: right ovary for CAPA-IVM and left ovary for minimal-stimulation OS-IVF. * Access to partner or donor sperm for fertilization/ICSI according to clinic protocol. * Willing and a…
Immature cumulus-oocyte complexes are retrieved from the right ovary before ovarian stimulation and undergo a biphasic CAPA-IVM process. The first phase is a pre-maturation/capacitation culture intended to maintain meiotic arrest while supporting developmental competence. Oocytes are then transferred to maturation conditions and assessed for maturation to metaphase II (MII). Mature oocytes may subsequently undergo ICSI and standard embryo culture according to clinical practice.
An investigational in-house reproductive culture medium is used during the pre-maturation/capacitation phase of CAPA-IVM for immature cumulus-oocyte complexes. The proprietary formulation is prepared for use in the CAPA-IVM laboratory procedure. Following the pre-maturation phase, oocytes are transferred to maturation conditions and assessed for MII maturation.
After completion of right-ovary CAPA-IVM aspiration, minimal controlled ovarian stimulation of the left ovary begins on menstrual cycle Day 5. The regimen includes clomiphene citrate for approximately 9 days and follitropin beta for approximately 3 days with ultrasound and/or hormonal monitoring. Final oocyte maturation is initiated using leuprolide acetate as a GnRH-agonist trigger. Oocytes are subsequently retrieved from the left ovary and undergo standard IVF/ICSI and embryo culture according to clinical practice.
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