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Can exosomes boost egg maturation in women with low ovarian reserve?

NCT ID NCT07249411

Knowledge-focused Sponsor: Biotech Fertility C.A. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This early study looked at whether adding a woman's own exosomes (tiny particles from her cells) to the liquid used to grow eggs in the lab could help more eggs mature. 32 women with low ovarian reserve took part. The goal was to see if the method was safe and worked, but no embryos were transferred in this phase.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

32 people

The number who actually took part.

Started

Jan 2023

Finished

Jan 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

38 to 48 years

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Women with primary or secondary infertility associated with diminished ovarian reserve, defined by ultrasound findings and laboratory parameters (FSH \> 10 mIU/mL and estradiol \< 60 pg/mL). * Serum anti-Müllerian hormone (AMH) concentration \< 1 ng/mL. * Antral follicle count \< 3-6 follicles per ovary. * Anatomical preservation of both ovaries. * Body mass index (BMI) between 24.5 and 30 kg/m². * Absence of active oncological pathologies or connective tissue diseases (collagenopathies). * No history of clinically relevant hematological disorders. * Adequate serum levels of vitamins essential for reproductive function, including vitamin D, B-complex, and vitamin C. * Last live birth within ≤ 10 years prior to study initiation. * Normal thyroid function (TSH and free thyroid hormones within range). * Absence of antiphospholipid antibody syndrome. * Male partner with semen parameters within normal limits, according to the World Health Organization (WHO) criteria, 2010 (5th edition) and 2021 (6th edition). * Signed informed consent for participation in the study. Exclusion Criteria: * • Patients without a diagnosis of infertility. * Women without documented diminished ovarian reserve. * Serum anti-Müllerian hormone (AMH) concentration \> 1 ng/mL. * Antral follicle count \> 3-6 follicles per ovary. * Absence of one or both ovaries. * Body mass index (BMI) \> 30 kg/m². * Presence of active oncological pathologies or connective tissue diseases (collagenopathies). * History of clinically relevant hematological disorders. * Deficient or altered serum levels of vitamins essential for reproductive function (vitamin D, B-complex, and vitamin C). * Last live birth \> 10 years prior to study initiation. * Altered thyroid function (TSH or free thyroid hormones out of range). * History of antiphospholipid antibody syndrome. * Male partner with abnormal semen parameters according to the World Health Organization (WHO) criteria, 2010 (5th edition) and 2021 (6th edition). * Refusal to sign informed consent for study participation.

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Conditions

The condition(s) this trial relates to.

ovarian dysfunction

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Diminished ovarian reserve

Contacts and locations

Locations

  • Biotech Fertility C.A

    Caracas, 1080, Venezuela

More trials for these conditions

Other studies related to the condition(s) this trial covers.