Intra-ovarian CAPA-IVM vs Standard IVM

Part of paid clinical trials in New York, New York.

Sponsor
New Hope Fertility Center
Study ID
NCT07858435
Status
Not Yet Recruiting

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Conditions

  • Infertility
  • Infertility (IVF Patients)
  • Infertility Female

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 38 Years
Healthy Volunteers
Not accepted

Interventions

  • CAPA-IVM — PROCEDURE
    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 — DEVICE
    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 — PROCEDURE
    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.

Study Details

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.

Key Dates

First listed
Oct 5, 2026
Start date
Oct 31, 2026
Status verified
Sep 2026
Primary completion
Mar 31, 2027
Completion
Oct 31, 2027

Study Design

Enrollment
20 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Within-Patient CAPA-IVM and Minimal-Stimulation OS-IVF
    All participants undergo a within-patient comparison in the same menstrual cycle. The right ovary undergoes retrieval of immature oocytes for CAPA-IVM beginning on or after menstrual cycle Day 3, before ovarian stimulation. The left ovary subsequently undergoes minimal controlled ovarian stimulation beginning on Day 5, followed by oocyte retrieval and standard IVF/ICSI. Outcomes are compared according to ovary and oocyte origin, with each participant serving as her own internal control.

Primary Outcome Measure

Maturation Rate to Metaphase II (MII) Following CAPA-IVM [ Time Frame: Up to approximately 54 hours after initiation of CAPA-IVM culture ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
New Hope Fertility CenterNew YorkNew York10021
Clinical Coordinators
[email protected]
212-969-7461

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By research site
New Hope Fertility Center· New York, NY

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