Aspire In Vitro Maturation Study

NCT07789730 | Enrolling By Invitation FDA Device

• 1 other identifier: IRI-ASP-2026-02
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Infertility; In Vitro Maturation of Oocytes; Assisted Reproduction Technologies

Keywords

Fertility treatment; Assisted Reproductive Technology; Infertility

Outcome Measures

Primary Outcomes (1)

• Metaphase II rate

  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

Secondary Outcomes (9)

• Number of MII oocytes

  Assessed approximately 40 hours post egg retrieval

• Fertilization rate

  Assessed 16-18 hours post fertilization

• Number of blastocysts

  Assessed 5-7 days post fertilization

• Number of blastocysts vitrified

  Assessed 5-7 days post fertilization

• Number of blastocysts submitted for PGT-A

  Assessed 5-7 days post fertilization

Study Arms (1)

CAPA-IVM

EXPERIMENTAL

Patients will undergo egg retrieval prior to in vitro maturation with CAPA-IVM system and subsequent frozen embryo transfer.

Device: CAPA-IVM

Interventions

CAPA-IVM DEVICE

CAPA-IVM is a two-step IVM process to mature oocytes in the laboratory after egg retrieval.

CAPA-IVM

Eligibility Criteria

• Age: 18 Years - 37 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Inception Fertility Research Institute, LLC: lead
• Lavima Fertility: collaborator

Study Sites (1)

Aspire Fertility Houston

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: All patients will receive the same treatment protocol

Study Record Dates

• First Submitted: August 20, 2026
• First Posted: August 27, 2026
• Study Start: August 26, 2026
• Primary Completion (Estimated): February 1, 2028
• Study Completion (Estimated): February 1, 2028
• Last Updated: August 27, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)