ClinicalTrials.gg
Enrolling by invitationNCT07789730AIMUpdated Aug 27, 2026

Aspire In Vitro Maturation Study

An interventional study of CAPA-IVM in Infertility, In Vitro Maturation of Oocytes and Assisted Reproduction Technologies, sponsored by Inception Fertility Research Institute, LLC. Enrolling by invitation at 1 site in United States. Open to female participants aged 18 Years to 37 Years. Per ClinicalTrials.gov, last updated 2026-08-27.

Sponsored by Inception Fertility Research Institute, LLC · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Not applicable
Ages
18 Years to 37 Years
Sex
Female
01

Study 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 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.

02

Conditions studied

  • Infertility
  • In Vitro Maturation of Oocytes
  • Assisted Reproduction Technologies

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Keywords

  • Fertility treatment
  • Assisted Reproductive Technology
  • Infertility
03

In context

Infertility

2,085 studies on the registry are indexed under Infertility; 357 are open to participants now.

This study's planned enrollment of 40 is below the median of 135 across 1,412 interventional studies indexed under Infertility.

Browse Infertility studies →

Lead sponsor

Inception Fertility Research Institute, LLC is the lead sponsor of 12 studies on the registry; 5 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 37 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Signed Form to participate in this study voluntarily.
  2. Age 18-37 years at the time of starting the CAPA-IVM cycle.
  3. (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

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 systemic disease (heart, liver, kidney or other organs) that would prevent or compromise pregnancy or participation in this study.
  12. Pregnancy or 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 medicinal product.
  18. Previous participation in this study.
Terms in these criteria, in plain language(5)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
40 participants (estimated)

Study arms

  • Experimental
    CAPA-IVM

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

    Device: CAPA-IVM

Interventions

  • DeviceCAPA-IVM

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

06

What researchers measure

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.

    Time frame: Assessed approximately 40 hours after egg retrieval

Secondary outcomes

  1. Number of MII oocytes

    The number of oocytes that reach the metaphase II (MII) stage of development after CAPA-IVM culture

    Time frame: Assessed approximately 40 hours post egg retrieval

  2. Fertilization rate

    The fertilization rate is defined as the number of embryos that have 2 pro-nuclei post fertilization by intracytoplasmic sperm injection (ICSI)

    Time frame: Assessed 16-18 hours post fertilization

  3. Number of blastocysts

    The number of embryos that make it to the blastocyst stage of development post fertilization

    Time frame: Assessed 5-7 days post fertilization

  4. Number of blastocysts vitrified

    The number of embryos that are cryopreserved by vitrification post fertilization

    Time frame: Assessed 5-7 days post fertilization

  5. Number of blastocysts submitted for PGT-A

    The number of embryos that are biopsied and samples sent for PGT-A testing

    Time frame: Assessed 5-7 days post fertilization

  6. Number of euploid blastocysts

    Number of embryos that had a euploid result from PGT-A testing

    Time frame: Assessed 2-4 weeks post embryo biopsy

  7. 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

    Time frame: Assessed 9-11 days post embryo transfer

  8. Ongoing pregnancy rate

    The number of patients who have an ongoing intrauterine pregnancy at the last study visit

    Time frame: Assessed approximately 10 weeks post embryo transfer

  9. Live birth rate

    Number of patients who had a live birth after embryo transfer

    Time frame: Assessed approximately 40 weeks post embryo transfer

07

Study locations

1 site
  • Aspire Fertility Houston
    Houston, Texas 77030, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 27, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07789730
Collaborators
Lavima Fertility
Responsible party
Sponsor
First posted
Aug 27, 2026
Start date
Aug 26, 2026
Primary completion
Feb 2028 (estimated)
Completion
Feb 2028 (estimated)
Last update
Aug 27, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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