Automated in vitro fertilization process
Automation of the In Vitro Fertilization Laboratory: A Validation Study
This study is testing a new automated system for in vitro fertilization to see if it can improve the success rates for people undergoing assisted reproductive technology.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 150 (estimated) |
| Ages | 18 Years to 45 Years |
| Sex | All |
| Sponsor | Conceivable Life Sciences Industry-sponsored |
| Locations | 2 sites (Mexico City, Mexico City and 1 other locations) |
| Trial ID | NCT06581068 on ClinicalTrials.gov |
What this trial studies
This study focuses on improving assisted reproductive technology (ART) by utilizing an automated system called AURA for the in vitro fertilization process. Patients undergoing ART will have their sperm, eggs, and embryos processed through various subsystems of AURA, which includes specific procedures for sperm preparation, egg isolation, fertilization, incubation, and vitrification. A portion of the cumulus-oocyte complexes will be processed using standard methods for comparison, allowing researchers to evaluate the effectiveness of the automated approach. The goal is to enhance the efficiency and success rates of ART treatments.
Who should consider this trial
Good fit: Ideal candidates include women aged 18-39 with a medical indication for ART and a body mass index between 20 and 29, or women aged 18-45 utilizing donor eggs.
Not a fit: Patients with recurrent pregnancy loss, previous fertilization failures, or uterine factors that may compromise treatment are unlikely to benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve the success rates of in vitro fertilization for patients struggling with infertility.
How similar studies have performed: While the use of automation in ART is an emerging field, similar studies have shown promising results in enhancing the efficiency of fertility treatments.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Informed consent signed by the patients before treatment. * Medical indication to perform assisted reproductive technology. * Body mass index between 20 and 29 kg/m2 (female participants only). * For women with indication of utilizing autologous eggs: * Anti-Müllerian Hormone (AMH) value of at least 1.5 ng/mL. * 18 - 39 years of age. * For women utilizing donor eggs (egg donor age 18-28 years): * 18 - 45 years of age. Exclusion Criteria: * Patients diagnosed with recurrent pregnancy loss. * Inaccessible ovaries for puncture. * History of total or partial fertilization failure in a previous fertility treatment. * History of repeated implantation failure defined as three previous unsuccessful embryo transfers. * Uterine factors (e.g. fibroids, uterine surgeries, Müllerian malformations) at the discretion of the medical team and based on its impact on success and/or risk to the patient or the pregnancy may compromise treatment prognosis). * Untreated hydrosalpinx * Severe endometriosis III, IV, presence of endometriomas and/or history of endometrioma resection. * Polycystic ovarian syndrome. * Patients with any of the following severe male factor infertility: * Sperm concentrations less than 5 million per mL * Progressive motility less than 5% * Others (e.g, globozoospermia and seminal infections) at the discretion of the medical team and based on its impact on success. * Surgically retrieved sperm (TESE, MESA, PESA) * Pre-existing conditions compromising reproductive (e.g., thrombophilia, chronic degenerative and autoimmune diseases, uncontrolled hormonal disorders). * Any other case of abnormalities that could compromise success rates according to the criteria of clinical personnel in charge. * Inability to adhere to the medical protocols and/or schedules for personal reasons. * Intercurrent medical disorder
Where this trial is running
Mexico City, Mexico City and 1 other locations
- New Hope Fertility Centre, Mexico City — Mexico City, Mexico City, Mexico (Recruiting)
- Reina Madre — Mexico City, Mexico (Recruiting)
Study contacts
- Principal investigator: Jacques Cohen, PhD — Conceivable Life Sciences
- Study coordinator: Stephanie Kuku, MD
- Email: Stephanie@conceivable.life
- Phone: 1-833-737-2448
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.