InfertilityAIMNCT07789730
Aspire In Vitro Maturation Study
A study testing CAPA-IVM in people with Infertility and In Vitro Maturation of Oocytes, run by Inception Fertility Research Institute, LLC at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 37 years, women only
- Conditions the study is for
- Infertility, In Vitro Maturation of Oocytes, Assisted Reproduction Technologies
- What is being tested?
- CAPA-IVM
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Aug 2026to Feb 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 37 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
Read the detailed description
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.
- Being tested
- CAPA-IVM
- Keywords
- Fertility treatment, Assisted Reproductive Technology, Infertility
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CAPA-IVMDevice
CAPA-IVM is a two-step IVM process to mature oocytes in the laboratory after egg retrieval.
| Study group | Role | What they receive |
|---|---|---|
| CAPA-IVM | Experimental | Patients will undergo egg retrieval prior to in vitro maturation with CAPA-IVM system and subsequent frozen embryo transfer. Receives: Device: CAPA-IVM |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Assessed approximately 40 hours after egg retrieval
Secondary outcomes (9)
Number of MII oocytes
The number of oocytes that reach the metaphase II (MII) stage of development after CAPA-IVM culture
Measured: Assessed approximately 40 hours post egg retrieval
Fertilization rate
The fertilization rate is defined as the number of embryos that have 2 pro-nuclei post fertilization by intracytoplasmic sperm injection (ICSI)
Measured: Assessed 16-18 hours post fertilization
Number of blastocysts
The number of embryos that make it to the blastocyst stage of development post fertilization
Measured: Assessed 5-7 days post fertilization
Number of blastocysts vitrified
The number of embryos that are cryopreserved by vitrification post fertilization
Measured: Assessed 5-7 days post fertilization
Number of blastocysts submitted for PGT-A
The number of embryos that are biopsied and samples sent for PGT-A testing
Measured: Assessed 5-7 days post fertilization
Number of euploid blastocysts
Number of embryos that had a euploid result from PGT-A testing
Measured: Assessed 2-4 weeks post embryo biopsy
Positive beta-hCG rate
The number of patients with a serum QHCG level greater than 5 after embryo transfer divided by the total number of embryo transfers
Measured: Assessed 9-11 days post embryo transfer
Ongoing pregnancy rate
The number of patients who have an ongoing intrauterine pregnancy at the last study visit
Measured: Assessed approximately 10 weeks post embryo transfer
Live birth rate
Number of patients who had a live birth after embryo transfer
Measured: Assessed approximately 40 weeks post embryo transfer
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2026
- Study start26 Aug 2026
- Primary completionFeb 2028 (estimated)
- Study completionFeb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfertilityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- All patients will receive the same treatment protocol
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Inception Fertility Research Institute, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Lavima Fertility
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07789730
- Sponsor's protocol ID
- IRI-ASP-2026-02
- Acronym
- AIM
- Status last verified
- Aug 2026
- First submitted
- 20 Aug 2026
- Last updated
- 27 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study Assessing the Feasibility of CAPA-IVM in Participants With Good Ovarian Reserve
- ClinicalTrials.gov ID
- NCT07789730
- Acronym / sponsor ID
- AIM / IRI-ASP-2026-02
- Keywords
- Fertility treatment, Assisted Reproductive Technology, Infertility
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Inception Fertility Research Institute, LLCIndustry (pharma, biotech, devices)
- Collaborators
- Lavima Fertility
- Study start
- 26 Aug 2026 (actual)
- Primary completion
- Feb 2028 (estimated)
- Study completion
- Feb 2028 (estimated)
- First posted
- 27 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All patients will receive the same treatment protocol
| Arm | Type | Receives |
|---|---|---|
| CAPA-IVM | Experimental | Device: CAPA-IVMPatients will undergo egg retrieval prior to in vitro maturation with CAPA-IVM system and subsequent frozen embryo transfer. |
Who may qualify
- Ages
- 18 to 37 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (18 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CAPA-IVMCAPA-IVM is a two-step IVM process to mature oocytes in the laboratory after egg retrieval. | Device | CAPA-IVM |
Primary outcome
Metaphase II rate
Time frame: 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.
9 secondary outcomes
Number of MII oocytes
Time frame: Assessed approximately 40 hours post egg retrieval
Fertilization rate
Time frame: Assessed 16-18 hours post fertilization
Number of blastocysts
Time frame: Assessed 5-7 days post fertilization
Number of blastocysts vitrified
Time frame: Assessed 5-7 days post fertilization
Number of blastocysts submitted for PGT-A
Time frame: Assessed 5-7 days post fertilization
Number of euploid blastocysts
Time frame: Assessed 2-4 weeks post embryo biopsy
Positive beta-hCG rate
Time frame: Assessed 9-11 days post embryo transfer
Ongoing pregnancy rate
Time frame: Assessed approximately 10 weeks post embryo transfer
Live birth rate
Time frame: Assessed approximately 40 weeks post embryo transfer
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CAPA-IVM in people with Infertility and In Vitro Maturation of Oocytes, run by Inception Fertility Research Institute, LLC at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 27 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Metaphase II rate (time frame: Assessed approximately 40 hours after egg retrieval). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2026.