Hormone-free Antral Retrieval for Viable Embryo Storage & Transfer (HARVEST)

August 28, 2026 updated by: Kevin Doody

A Prospective Adaptive Pilot Study of Serial Unstimulated Oocyte Retrieval and CAPA-IVM 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 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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 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, 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 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 Type

Interventional

Enrollment (Estimated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Texas
      • Bedford, Texas, United States, 76104
        • CARE Fertility Texas
        • Principal Investigator:
          • Kevin Doody, MD
        • Contact:
        • Sub-Investigator:
          • Kathy Doody, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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, ICSI, blastocyst culture, PGT-A, embryo vitrification/accumulation, and single euploid embryo transfer if a suitable embryo is available.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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, with each participant serving as her own control across serial retrievals.
From first egg retrieval to final PGT-A results, approximately 4 weeks.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kevin Doody

Collaborators

Lavima Fertility

Investigators

  • Principal Investigator: Kevin Doody, MD, CARE Fertility Texas

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 1, 2026

Primary Completion (Estimated)

March 1, 2027

Study Completion (Estimated)

March 1, 2028

Study Registration Dates

First Submitted

August 28, 2026

First Submitted That Met QC Criteria

August 28, 2026

First Posted (Actual)

September 3, 2026

Study Record Updates

Last Update Posted (Actual)

September 3, 2026

Last Update Submitted That Met QC Criteria

August 28, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CARE-2026-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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