CompletedNot Applicable

Exosome-Enriched Culture Media to Enhance In Vitro Maturation and Embryo Development in Poor Ovarian Responders Undergoing IVF

Venezuela10 participantsStarted 2023-07-02

Plain-language summary

Evaluating the Efficacy of Exosome-Enriched Culture Media to Enhance In Vitro Maturation and Embryo Development in Poor Ovarian Responders Undergoing IVF Summary: This is a prospective, randomized controlled trial designed to assess whether supplementing standard IVF culture media with exosomes can improve the short-term in vitro maturation (IVM) of immature MI oocytes in poor ovarian responder patients. Sixty women aged 35-42 who meet Bologna criteria for poor ovarian response will be recruited and randomized into two groups: Control group: MI oocytes cultured in standard IVF media. Intervention group: MI oocytes cultured in IVF media supplemented with 10 µg of GMP-certified exosomes per well. The primary outcome is the proportion of MI oocytes maturing to MII within 4 hours. Secondary outcomes include fertilization rates, embryo quality, blastocyst development, and clinical pregnancy rates. This study aims to explore a novel approach to improving oocyte yield and embryo development in poor responder IVF cycles, potentially reducing the need for repeated treatments and enhancing patient outcomes.

Who can participate

Age range

35 Years – 45 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria:Inclusion Criteria: Women aged 35 to 42 years Undergoing IVF with an antagonist protocol Meet at least two Bologna criteria for poor ovarian response Provide written informed consent - Exclusion Criteria: * Exclusion Criteria: Severe male factor infertility requiring surgical sperm retrieval Known untreated hydrosalpinx Uterine anomalies that impair implantation Known chromosomal abnormalities Participation in another investigational study within 3 months

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Proportion of MI Oocytes Achieving MII Maturation

Timeframe: Within 4 hours post-culture

Trial details

NCT IDNCT07085312

SponsorFertiaguerrevere

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-07-30

View on ClinicalTrials.gov More Poor Ovarian Response trials