- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07789730
Aspire In Vitro Maturation Study (AIM)
26 de agosto de 2026 actualizado por: 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.
Descripción general del estudio
Estado
Inscripción por invitación
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Intervencionista
Inscripción (Estimado)
40
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
-
-
Texas
-
Houston, Texas, Estados Unidos, 77030
- Aspire Fertility Houston
-
-
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
Acepta Voluntarios Saludables
No
Descripción
Inclusion Criteria:
- Signed Informed Consent Form to participate in this study voluntarily.
- Age 18-37 years at the time of starting the CAPA-IVM cycle.
- Body mass index (BMI) ≤38 kg/m2.
- Serum AMH levels greater than or equal to 3.5 ng/mL.
- Have an indication for IVM/IVF cycle.
- Have not received more than two previous treatments of IVM/IVF.
- Willing and able to comply with trial procedures, including oocyte pick-up from small follicles and to follow a CAPA-IVM cycle.
- 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.
- 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:
- Prior ovarian surgery.
- Known uterine abnormalities (adenomyosis, leiomyoma (≥5 cm), bicornuate uterus, intrauterine adhesion) that would compromise successful pregnancy or live birth.
- Had received ovarian stimulation within the last 3 months for ovulation induction or IVF
- Had evidence of a very low oocyte maturation rate (oocyte maturation rate < 50% in any previous IVF or IVM cycle).
- For male partners: severe oligoasthenoteratozoospermia, requirement for retrograde ejaculation procedures or surgical sperm retrievals. Donor sperm is permitted.
- Known chromosomal abnormalities in participant or partner.
- Have herself or partner with acute urinary tract infection or sexually transmitted diseases.
- Have herself or partner a severe mental disorder, such as schizophrenia, bipolar affective disorder, or intellectual disability caused by mental disorders.
- Have a history of recurrent pregnancy loss defined as two or more clinical pregnancies without live birth.
- 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.
- Any known clinically significant systemic disease (heart, liver, kidney or other organs) that would prevent or compromise pregnancy or participation in this study.
- Pregnancy or contraindication to pregnancy.
- Undiagnosed vaginal bleeding.
- Known drug or alcohol abuse or dependency for the participant or partner for the last 12 months.
- Current or past (3 months) smoking habit of 10 or more cigarettes per day.
- Had a recent exposure to teratogenic radiation, drugs or toxins which could still be active during the study period.
- Currently participating in another clinical trial or receiving an investigational medicinal product.
- Previous participation in this study.
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: 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.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Metaphase II rate
Periodo de tiempo: 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
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Number of MII oocytes
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Colaboradores
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
26 de agosto de 2026
Finalización primaria (Estimado)
1 de febrero de 2028
Finalización del estudio (Estimado)
1 de febrero de 2028
Fechas de registro del estudio
Enviado por primera vez
20 de agosto de 2026
Primero enviado que cumplió con los criterios de control de calidad
26 de agosto de 2026
Publicado por primera vez (Actual)
27 de agosto de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
27 de agosto de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
26 de agosto de 2026
Última verificación
1 de agosto de 2026
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- IRI-ASP-2026-02
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
Sí
producto fabricado y exportado desde los EE. UU.
No
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