Hormone-free Antral Retrieval for Viable Embryo Storage & Transfer

Part of paid clinical trials in Bedford, Texas.

Sponsor
Kevin Doody
Study ID
NCT07801105
Status
Not Yet Recruiting

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Conditions

  • Infertility

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 35 Years
Healthy Volunteers
Not accepted

Interventions

  • CAPA-IVM System — DEVICE
    The CAPA-IVM System Kit will be used in the laboratory to support collection, handling, capacitation, and maturation of immature cumulus-oocyte complexes retrieved from visible 4-9 mm antral follicles.
  • Serial Unstimulated Transvaginal Oocyte Retrieval — PROCEDURE
    Participants will undergo up to three unstimulated transvaginal oocyte retrievals targeting visible 4-9 mm antral follicles, without exogenous gonadotropin stimulation or ovulatory trigger medication.
  • ICSI, Blastocyst Culture, PGT-A, Embryo Vitrification/Accumulation, and Single Euploid Embryo Transfer — PROCEDURE
    Retrieved oocytes will undergo CAPA-IVM followed by ICSI, blastocyst culture, PGT-A, embryo vitrification/accumulation, and single euploid embryo transfer if a suitable euploid embryo is available.

Study Details

This study is testing whether eggs can be collected from small follicles without using the usual ovarian stimulation medications. Participants will have up to three egg retrieval procedures. The eggs collected during each retrieval will be matured in the laboratory using the CAPA-IVM process, fertilized, grown into embryos, and tested to identify chromosomally normal embryos. Embryos from the retrievals may be frozen and accumulated. If a suitable embryo is available, one chromosomally normal embryo may be transferred. The study will also monitor safety, hormone levels, follicle development, embryo development, pregnancy results, and how well participants tolerate the study procedures.

Key Dates

First listed
Sep 3, 2026
Start date
Sep 30, 2026
Status verified
Aug 2026
Primary completion
Mar 31, 2027
Completion
Mar 31, 2028

Study Design

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

Arms

  • Experimental: Interventional, single-arm, prospective, open-label, adaptive pilot study
    Participants will undergo up to three unstimulated transvaginal oocyte retrievals targeting visible 4-9 mm antral follicles, without ovarian stimulation or ovulatory trigger medication. Retrieved oocytes will undergo CAPA-IVM, ICSI, blastocyst culture, PGT-A, embryo vitrification/accumulation, and single euploid embryo transfer if a suitable embryo is available.

Primary Outcome Measure

Number of euploid embryos per retrieval [ Time Frame: From first egg retrieval to final PGT-A results, approximately 4 weeks. ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
CARE Fertility TexasBedfordTexas76104
Kevin Doody, MD
[email protected]
8179241572
Kevin Doody, MD (PRINCIPAL_INVESTIGATOR)
Kathy Doody, MD (SUB_INVESTIGATOR)

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CARE Fertility Texas· Bedford, TX

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