Infertility
Conditions
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
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.
Detailed description
This is a single-arm, prospective, open-label, adaptive pilot study designed to evaluate the feasibility of serial unstimulated transvaginal oocyte retrieval followed by CAPA-IVM (Capacitation In Vitro Maturation) for euploid embryo accumulation in infertility patients with robust ovarian reserve. Approximately 30 participants will be enrolled. Participants will undergo serial unstimulated transvaginal oocyte retrieval procedures targeting visible 4-9 mm antral follicles. Retrieved cumulus-oocyte complexes will undergo CAPA-IVM (Capacitation In Vitro Maturation), followed by intracytoplasmic sperm injection, blastocyst culture, preimplantation genetic testing for aneuploidy, and embryo vitrification/accumulation. Euploid embryos generated across retrievals will be accumulated for subsequent single euploid embryo transfer according to the protocol and site clinical practice. The study will be conducted in two stages. Stage 1 will enroll approximately 10 participants using initially defined serial retrieval timing to evaluate feasibility, safety, follicle availability, and retrieval interval optimization. Following review of Stage 1 safety, feasibility, follicle emergence, and endocrine data, Stage 2 will enroll approximately 20 additional participants. Retrieval intervals in Stage 2 may be adjusted if supported by interim findings. The study will summarize retrieval-specific and participant-level outcomes, including follicle counts, oocyte yield, oocyte maturation, fertilization, blastocyst development, PGT-A (Preimplantation Genetic Testing for Aneuploidy) results, euploid embryo yield, embryo accumulation, and progression to single euploid embryo transfer. Safety and tolerability will be assessed throughout the study, including procedure-related complications, anesthesia/sedation-related events, antibiotic-related reactions, retrieval deferrals or discontinuations, and other adverse events.
Interventions
DEVICECAPA-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.
PROCEDURESerial 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.
PROCEDUREICSI, 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.
Sponsors
Kevin Doody
Lavima Fertility
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 35 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Contacts
CONTACTKevin Doody, MD
PRINCIPAL_INVESTIGATORKevin Doody, MD
CARE Fertility Texas
Outcome results
None listed