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Intra-ovarian CAPA-IVM vs Standard IVM
Sponsor: New Hope Fertility Center
Summary
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.
Official title: A Within-Patient Comparison of CAPA-IVM (Biphasic Capacitation IVM) With the Contralateral Ovary Undergoing Minimal Controlled Ovarian Stimulation (OS-IVF)
Key Details
Gender
FEMALE
Age Range
18 Years - 38 Years
Study Type
INTERVENTIONAL
Enrollment
20
Start Date
2026-10
Completion Date
2027-10
Last Updated
2026-10-05
Healthy Volunteers
No
Interventions
CAPA-IVM
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.
In-House CAPA-IVM Pre-Maturation Medium
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.
Minimal-Stimulation OS-IVF
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.
Locations (1)
New Hope Fertility Center
New York, New York, United States