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

3. september 2026 opdateret af: Kevin Doody

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.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

30

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

  • Forenede Stater
    • Texas
      • Bedford, Texas, Forenede Stater, 76104
        • Rekruttering
        • CARE Fertility Texas
        • Ledende efterforsker:
          • Kevin Doody, MD
        • Kontakt:
        • Underforsker:
          • Kathy Doody, MD

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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 (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.
Enhed: 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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Number of euploid embryos per retrieval
Tidsramme: 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.
From first egg retrieval to final PGT-A results, approximately 4 weeks.

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Kevin Doody

Samarbejdspartnere

Lavima Fertility

Efterforskere

  • Ledende efterforsker: Kevin Doody, MD, CARE Fertility Texas

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. september 2026

Primær færdiggørelse (Anslået)

1. marts 2027

Studieafslutning (Anslået)

1. marts 2028

Datoer for studieregistrering

Først indsendt

28. august 2026

Først indsendt, der opfyldte QC-kriterier

28. august 2026

Først opslået (Faktiske)

3. september 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

9. september 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

3. september 2026

Sidst verificeret

1. september 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • CARE-2026-01

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

IPD-planbeskrivelse

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.

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ja

produkt fremstillet i og eksporteret fra U.S.A.

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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