NCT07801105 · Kevin Doody
Hormone-free Antral Retrieval for Viable Embryo Storage & Transfer
(HARVEST)
What this study is about
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.
View original scientific description
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.
Interventions
DEVICE
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.
PROCEDURE
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.
PROCEDURE
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 measures
Number of euploid embryos per retrieval
Time frame: 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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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.
- 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.
- 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.
Where
- Bedford, Texas
Collaborators
Lavima Fertility
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Sep 9, 2026 · Source of record for eligibility and locations