Recruiting

CAPA-IVM

Sponsor:

Kevin Doody

Code:

NCT07801105

Conditions

Infertility

Eligibility Criteria

Sex: Female

Age: 18 - 35

Healthy Volunteers: Not accepted

Interventions

CAPA-IVM System

Serial Unstimulated Transvaginal Oocyte Retrieval

ICSI, Blastocyst Culture, PGT-A, Embryo Vitrification/Accumulation, and Single Euploid Embryo Transfer

Study Details

Brief summary:

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 (Capacitation In Vitro Maturation) 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.

Conditions

Infertility

Study ID

NCT07801105

Start date

Sep, 2026

Status verified date

Sep, 2026

Completion date

Mar, 2028

Anticipated

Primary completion date

Mar, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 35

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Signed informed consent.
  • Female participant aged 18-35 years.
  • Diagnosis of infertility requiring IVF/ICSI, including unexplained infertility or mild male factor infertility.
  • BMI 18-30 kg/m².
  • AMH ≥2.5 ng/mL.
  • AFC ≥12.
  • Basal FSH <8 IU/L.
  • Ovaries accessible for transvaginal retrieval.
  • Willing to undergo serial unstimulated TVORs with adaptive retrieval timing.
  • Willing to undergo CAPA-IVM, ICSI, blastocyst culture, PGT-A, embryo vitrification/accumulation, and single euploid embryo transfer.
  • Willing to undergo serial ultrasound and endocrine monitoring.
  • Willing and able to comply with study procedures and follow-up.

Exclusion Criteria:

  • Prior ovarian surgery.
  • Ovarian endometrioma.
  • Inaccessible ovaries.
  • Significant uterine factor expected to compromise implantation, pregnancy, or live birth.
  • Significant medical comorbidity that would increase risk of TVOR, pregnancy, or study participation.
  • AMH <2.5 ng/mL.
  • AFC <12.
  • Basal FSH ≥8 IU/L.
  • BMI <18 or >30 kg/m².
  • Current smoking or nicotine use within 3 months of screening.
  • Active pelvic infection, untreated STI, or acute urinary tract infection.
  • Contraindication to transvaginal oocyte retrieval, anesthesia/sedation, pregnancy, or antibiotic prophylaxis.
  • Known chromosomal abnormality in the participant or sperm source that would confound study outcome assessment.
  • Severe male factor infertility requiring surgical sperm retrieval, unless specifically permitted by the final protocol.
  • Recent exposure to teratogenic radiation, drugs, or toxins.
  • Current participation in another interventional clinical trial that may confound outcomes.
  • Previous participation in the CARE study.

Study Design

Enrollment

30 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

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 (Capacitation In Vitro Maturation), ICSI (Intracytoplasmic Sperm Injection), blastocyst culture, PGT-A (Preimplantation Genetic Testing for Aneuploidy), embryo vitrification/accumulation, and single euploid embryo transfer if a suitable embryo is available.

Interventions

CAPA-IVM System

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

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

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.

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 and Locations

Central contacts

Kevin Doody, MD

817-924-1572kevind@embryo.net

Locations

CARE Fertility Texas

Recruiting

Bedford, Texas, United States, 76104

Contacts

Kevin Doody, MD

8179241572kevind@embryo.net

Principal Investigator:

Kevin Doody, MD

More Information

Sponsor

Kevin Doody

Last update posted

Sep 9, 2026

Last verified

Sep, 2026

Keywords

  • Infertility
  • IVF without ovarian stimulation
  • IVF without fertility shots
  • Unstimulated egg retrieval
  • Egg retrieval without stimulation
  • In vitro maturation
  • IVM
  • CAPA-IVM
  • Egg maturation in the laboratory
  • Embryo testing
  • PGT-A
  • Single embryo transfer
  • Unexplained infertility
  • Mild male factor infertility
  • Robust ovarian reserve

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Kevin Doody on 2026-09-09.