Recruiting
Not applicable
Hormone-free Antral Retrieval for Viable Embryo Storage & Transfer
Condition(s) studied
Infertility
Investigational drug(s) / intervention(s)
CAPA-IVM SystemSerial Unstimulated Transvaginal Oocyte RetrievalICSI, Blastocyst Culture, PGT-A, Embryo Vitrification/Accumulation, and Single Euploid Embryo Transfer
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.
Study 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.
Eligibility
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.
Primary outcome measure(s)
- Number of euploid embryos per retrieval — From first egg retrieval to final PGT-A results, approximately 4 weeks.
Number of euploid embryos per retrieval, assessed by PGT-A (Preimplantation Genetic Testing for Aneuploidy), with each participant serving as her own control across serial retrievals.
Trial sites (1)
| Facility | City | Region | Status |
|---|
| CARE Fertility Texas |
Bedford |
Texas |
Recruiting |
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