InfertilityHARVESTNCT07801105
Hormone-free Antral Retrieval for Viable Embryo Storage & Transfer
A study testing CAPA-IVM System, Serial Unstimulated Transvaginal Oocyte Retrieval and ICSI, Blastocyst Culture, PGT-A, Embryo Vitrification/Accumulation, and Single Euploid Embryo Transfer in people with Infertility, run by Kevin Doody at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women only
- Conditions the study is for
- Infertility
- What is being tested?
- CAPA-IVM System, Serial Unstimulated Transvaginal Oocyte Retrieval and ICSI, Blastocyst Culture, PGT-A, Embryo Vitrification/Accumulation, and Single Euploid Embryo Transfer
- Type of treatment
- Injection or infusion, Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2026to Mar 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
CARE Fertility Texas
Bedford, Texas, 76104
Kevin Doody, MD, 8179241572, kevind@embryo.net
Kevin Doody, MD
About this study
Official title: A Prospective Adaptive Pilot Study of Serial Unstimulated Oocyte Retrieval and CAPA-IVM (Capacitation In Vitro Maturation) for Euploid Embryo Accumulation in Women With Robust Ovarian Reserve
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.
Read the 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.
- Conditions
- Infertility
- Being tested
- CAPA-IVM System, Serial Unstimulated Transvaginal Oocyte Retrieval, ICSI, Blastocyst Culture, PGT-A, Embryo Vitrification/Accumulation, and Single Euploid Embryo Transfer
- 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
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CAPA-IVM SystemDevice
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 RetrievalProcedure or surgery
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 TransferProcedure or surgery
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 group | Role | What they receive |
|---|---|---|
| Interventional, single-arm, prospective, open-label, adaptive pilot study | Experimental | 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. Receives: Device: CAPA-IVM System; Procedure: Serial Unstimulated Transvaginal Oocyte Retrieval; Procedure: ICSI, Blastocyst Culture, PGT-A, Embryo Vitrification/Accumulation, and Single Euploid Embryo Transfer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of euploid embryos per retrieval
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.
Measured: From first egg retrieval to final PGT-A results, approximately 4 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2026
- Study startSep 2026 (estimated)
- Primary completionMar 2027 (estimated)
- Study completionMar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfertilityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kevin Doody
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Lavima Fertility
- Responsible party
- Sponsor-investigator, Kevin Doody, CARE Fertility Texas
- Investigators
- Kevin Doody, MD, Principal investigator, CARE Fertility Texas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07801105
- Sponsor's protocol ID
- CARE-2026-01
- Acronym
- HARVEST
- Status last verified
- Sep 2026
- First submitted
- 28 Aug 2026
- Last updated
- 9 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: Individual participant data will not be shared. Aggregate study results may be reported in publications, presentations, regulatory submissions, or other study reports. Participant confidentiality will be maintained in accordance with the informed consent, applicable privacy requirements, and institutional policies.
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Adaptive Pilot Study of Serial Unstimulated Oocyte Retrieval and CAPA-IVM (Capacitation In Vitro Maturation) for Euploid Embryo Accumulation in Women With Robust Ovarian Reserve
- ClinicalTrials.gov ID
- NCT07801105
- Acronym / sponsor ID
- HARVEST / CARE-2026-01
- Conditions
- Infertility
- Keywords
- Infertility, IVF without ovarian stimulation, IVF without fertility shots, Unstimulated egg retrieval, Egg retrieval without stimulation, In vitro maturation, IVM, CAPA-IVM
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Kevin DoodyIndustry (pharma, biotech, devices)
- Collaborators
- Lavima Fertility
- Study start
- Sep 2026 (estimated)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Mar 2028 (estimated)
- First posted
- 3 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Interventional, single-arm, prospective, open-label, adaptive pilot study | Experimental | Device: CAPA-IVM System, Procedure: Serial Unstimulated Transvaginal Oocyte Retrieval, Procedure: ICSI, Blastocyst Culture, PGT-A, Embryo Vitrification/Accumulation, and Single Euploid Embryo TransferParticipants 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. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (12 listed)
- 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.
Key exclusion criteria (17 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CAPA-IVM SystemThe 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. | Device | Interventional, single-arm, prospective, open-label, adaptive pilot study |
| Serial Unstimulated Transvaginal Oocyte RetrievalParticipants 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 or surgery | Interventional, single-arm, prospective, open-label, adaptive pilot study |
| ICSI, Blastocyst Culture, PGT-A, Embryo Vitrification/Accumulation, and Single Euploid Embryo TransferRetrieved 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. | Procedure or surgery | Interventional, single-arm, prospective, open-label, adaptive pilot study |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared. Aggregate study results may be reported in publications, presentations, regulatory submissions, or other study reports. Participant confidentiality will be maintained in accordance with the informed consent, applicable privacy requirements, and institutional policies.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Kevin Doody, MD principal investigator
CARE Fertility Texas
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CAPA-IVM System, Serial Unstimulated Transvaginal Oocyte Retrieval and ICSI, Blastocyst Culture, PGT-A, Embryo Vitrification/Accumulation, and Single Euploid Embryo Transfer in people with Infertility, run by Kevin Doody at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kevin Doody, MD (817-924-1572, kevind@embryo.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of euploid embryos per retrieval (time frame: From first egg retrieval to final PGT-A results, approximately 4 weeks.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2026.