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Aspire In Vitro Maturation Study (AIM)

26. august 2026 oppdatert av: Inception Fertility Research Institute, LLC

Pilot Study Assessing the Feasibility of CAPA-IVM in Participants With Good Ovarian Reserve

A study to assess the Capacitation - in-vitro maturation (CAPA-IVM) system as an option for patients with a good ovarian reserve to achieve pregnancy.

Studieoversikt

Status

Påmelding etter invitasjon

Intervensjon / Behandling

Detaljert beskrivelse

CAPA-IVM is being evaluated for its feasibility as an In vitro maturation (IVM) system in US fertility clinics. IVM is a laboratory process for maturing immature oocytes (eggs) outside of the body after egg retrieval. Egg retrievals are performed without prior ovarian stimulation.

Studietype

Intervensjonell

Registrering (Antatt)

40

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

    • Texas
      • Houston, Texas, Forente stater, 77030
        • Aspire Fertility Houston

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen

Tar imot friske frivillige

Nei

Beskrivelse

Inclusion Criteria:

  1. Signed Informed Consent Form to participate in this study voluntarily.
  2. Age 18-37 years at the time of starting the CAPA-IVM cycle.
  3. Body mass index (BMI) ≤38 kg/m2.
  4. Serum AMH levels greater than or equal to 3.5 ng/mL.
  5. Have an indication for IVM/IVF cycle.
  6. Have not received more than two previous treatments of IVM/IVF.
  7. Willing and able to comply with trial procedures, including oocyte pick-up from small follicles and to follow a CAPA-IVM cycle.
  8. Agree to culture all embryos to blastocyst stage, vitrify suitable blastocysts, and submit suitable blastocysts for PGT-A according to clinic protocol before determining transfer eligibility.
  9. Agree that only euploid CAPA-IVM-derived blastocysts will be eligible for transfer and that a single euploid blastocyst will be transferred per programmed FET cycle, unless a protocol-defined exception is prospectively justified by the investigator.

Exclusion Criteria:

  1. Prior ovarian surgery.
  2. Known uterine abnormalities (adenomyosis, leiomyoma (≥5 cm), bicornuate uterus, intrauterine adhesion) that would compromise successful pregnancy or live birth.
  3. Had received ovarian stimulation within the last 3 months for ovulation induction or IVF
  4. Had evidence of a very low oocyte maturation rate (oocyte maturation rate < 50% in any previous IVF or IVM cycle).
  5. For male partners: severe oligoasthenoteratozoospermia, requirement for retrograde ejaculation procedures or surgical sperm retrievals. Donor sperm is permitted.
  6. Known chromosomal abnormalities in participant or partner.
  7. Have herself or partner with acute urinary tract infection or sexually transmitted diseases.
  8. Have herself or partner a severe mental disorder, such as schizophrenia, bipolar affective disorder, or intellectual disability caused by mental disorders.
  9. Have a history of recurrent pregnancy loss defined as two or more clinical pregnancies without live birth.
  10. Known tumors of the ovary, breast, uterus, adrenal gland, pituitary or hypothalamus that would preclude to conduct a CAPA-IVM cycle without ovarian stimulation or participation in this study.
  11. Any known clinically significant systemic disease (heart, liver, kidney or other organs) that would prevent or compromise pregnancy or participation in this study.
  12. Pregnancy or contraindication to pregnancy.
  13. Undiagnosed vaginal bleeding.
  14. Known drug or alcohol abuse or dependency for the participant or partner for the last 12 months.
  15. Current or past (3 months) smoking habit of 10 or more cigarettes per day.
  16. Had a recent exposure to teratogenic radiation, drugs or toxins which could still be active during the study period.
  17. Currently participating in another clinical trial or receiving an investigational medicinal product.
  18. Previous participation in this study.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: N/A
  • Intervensjonsmodell: Enkeltgruppeoppdrag
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: CAPA-IVM
Patients will undergo egg retrieval prior to in vitro maturation with CAPA-IVM system and subsequent frozen embryo transfer.
CAPA-IVM is a two-step IVM process to mature oocytes in the laboratory after egg retrieval.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Metaphase II rate
Tidsramme: Assessed approximately 40 hours after egg retrieval
The metaphase II (MII) rate is defined as the number of oocytes that reach MII stage of development divided by the number of cumulus-oocyte-complexes (COCs) placed into CAPA-IVM culture.
Assessed approximately 40 hours after egg retrieval

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Number of MII oocytes
Tidsramme: Assessed approximately 40 hours post egg retrieval
The number of oocytes that reach the metaphase II (MII) stage of development after CAPA-IVM culture
Assessed approximately 40 hours post egg retrieval
Fertilization rate
Tidsramme: Assessed 16-18 hours post fertilization
The fertilization rate is defined as the number of embryos that have 2 pro-nuclei post fertilization by intracytoplasmic sperm injection (ICSI)
Assessed 16-18 hours post fertilization
Number of blastocysts
Tidsramme: Assessed 5-7 days post fertilization
The number of embryos that make it to the blastocyst stage of development post fertilization
Assessed 5-7 days post fertilization
Number of blastocysts vitrified
Tidsramme: Assessed 5-7 days post fertilization
The number of embryos that are cryopreserved by vitrification post fertilization
Assessed 5-7 days post fertilization
Number of blastocysts submitted for PGT-A
Tidsramme: Assessed 5-7 days post fertilization
The number of embryos that are biopsied and samples sent for PGT-A testing
Assessed 5-7 days post fertilization
Number of euploid blastocysts
Tidsramme: Assessed 2-4 weeks post embryo biopsy
Number of embryos that had a euploid result from PGT-A testing
Assessed 2-4 weeks post embryo biopsy
Positive beta-hCG rate
Tidsramme: Assessed 9-11 days post embryo transfer
The number of patients with a serum QHCG level greater than 5 after embryo transfer divided by the total number of embryo transfers
Assessed 9-11 days post embryo transfer
Ongoing pregnancy rate
Tidsramme: Assessed approximately 10 weeks post embryo transfer
The number of patients who have an ongoing intrauterine pregnancy at the last study visit
Assessed approximately 10 weeks post embryo transfer
Live birth rate
Tidsramme: Assessed approximately 40 weeks post embryo transfer
Number of patients who had a live birth after embryo transfer
Assessed approximately 40 weeks post embryo transfer

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

26. august 2026

Primær fullføring (Antatt)

1. februar 2028

Studiet fullført (Antatt)

1. februar 2028

Datoer for studieregistrering

Først innsendt

20. august 2026

Først innsendt som oppfylte QC-kriteriene

26. august 2026

Først lagt ut (Faktiske)

27. august 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

27. august 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

26. august 2026

Sist bekreftet

1. august 2026

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • IRI-ASP-2026-02

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Ja

produkt produsert i og eksportert fra USA

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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