Automation of Gamete Preparation, Intracytoplasmic Sperm Injection (ICSI), Embryo Culture, and Vitrification

Infertility Clinical Trial

Official title:

Automation of Gamete Preparation, Intracytoplasmic Sperm Injection (ICSI), Embryo Culture, and Vitrification: A Proof of Concept Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06074835
• Other study ID #: CP001
• Status: Recruiting
• Phase: N/A
• Start date: October 30, 2023
• Est. completion date: December 2024

Study information

• Verified date: January 2024
• Source: Conceivable Life Sciences
• Contact: Amaranta Martinez, MD
• Phone: +52 800 8905884
• Email: dra.amaranta[@]nhfc.mx
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Patients suffering from infertility may seek assisted conception treatment. In a full treatment cycle, the sperm and eggs (gametes) from the intended parents will be looked after by skilled laboratory staff (embryologists) who will rely on manual laboratory processes to achieve fertilization. The most commonly employed method to achieve fertilization is intracytoplasmic sperm injection (ICSI), a treatment that involves the injection of a single sperm cell directly inside an egg. The embryos so obtained are then be maintained in an appropriate environment (incubator) for several days before deciding whether they can be immediately used to attempt to establish a pregnancy (embryo transfer), or should be frozen in preparation for a future treatment (cryopreservation).

The laboratory steps required to complete a full assisted conception treatment (from sperm and egg retrieval, to fertilization, and then to embryo transfer and/or cryopreservation) are often manual and time-consuming, and thus the success of the treatment is highly dependent on the skill of individual staff and outcomes can be affected by fatigue, stress, and workload.

The combination of robotics and artificial intelligence (AI) has the potential to provide improvements to, and standardize, the fertility laboratory, but such integration has not been achieved routinely. Other medical fields, such as regenerative medicine, have long benefited from the implementation of robotic solutions; however, modern automation has yet to find its way into the fertility laboratory.

The goal for Conceivable Life Sciences (the study sponsor) is the delivery of a suite of solutions that, collectively, will allow a fully autonomous ICSI cycle to take place (from sperm/egg preparation, to sperm injection, to embryo culture and cryopreservation) in an effort to reduce costs, assist laboratory staff, and possibly, improve outcomes. The purpose of this study is to deliver a core aspect of this project: the digital control and individual automation of all key steps of a complete laboratory workflow. The data generated in this study will help the future development of these automated systems.

Patients undergoing an ICSI treatment may be recruited in this study. Their gametes (sperm and/or eggs) may be distributed across two groups (test and control) and undergo one or more elements of an automated full assisted conception workflow (for the test group) or a standard assisted conception workflow (for the control group). Robotic automation may include any of the following steps: robotic sperm preparation, robotic oocyte selection and denudation, robotic sperm injection, automated embryo culture, and automated cryopreservation. The resulting embryos may be employed for embryo transfer.

The main hypothesis of this study is that the use of robotic assistants as part of a full assisted conception cycle may improve laboratory workflows without reducing the treatment success rates.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 45
• Est. completion date: December 2024
• Est. primary completion date: October 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

• Medical indication to perform ICSI.

• Informed consent signed by the patients before treatment.

• Medical indication for the use of autologous or donor oocytes.

• Medical indication for the use of autologous or donor sperm.

• Motile sperm.

Exclusion Criteria:

• Recurrent pregnancy loss.

• Previous history of total fertilization failure.

• Surgical sperm retrieval.

• Severe male factor infertility.

• Known semen liquefaction problems.

• Any other case abnormalities that could potentially reduce success rates according to the criteria of the senior embryologist in charge.

Related Conditions & MeSH terms

• Infertility

Intervention

Device:
• Gamete preparation, ICSI, embryo culture and vitrification robot assistant
Patients undergoing an assisted conception treatment with medical indication to perform ICSI may be recruited in this study. The study will follow a sibling-oocyte and/or sibling embryo study design where oocytes and/or embryos obtained from a specific patient or couple will be randomly distributed across two groups (test and control) and undergo one or more elements of an automated assisted conception laboratory workflow (for the test group) or a standard assisted conception laboratory workflow (for the control group). Before distributing the samples, an embryologist will slightly blur the vision of the samples so that their morphology can no longer be clearly assessed. Robotic automation may include any of the following steps: robotic sperm preparation, robotic oocyte selection and denudation, robotic sperm injection, automated embryo culture, and automated cryopreservation. The resulting embryos may be employed for embryo transfer.

Other:
• Routine Manual ICSI Workflow
Routine Manual Icsi Workflow

Locations

Country	Name	City	State
Mexico	New Hope Fertility Centre, Guadalajara	Guadalajara	Jalisco
Mexico	New Hope Fertility Centre, Mexico City	Mexico City

Sponsors (1)

Lead Sponsor	Collaborator
Conceivable Life Sciences

Country where clinical trial is conducted

Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Timing	Time to complete each automated procedure	6 weeks from enrolment
Primary	Efficiency	proportion of automated procedures achieving their goal	6 weeks from enrolment
Primary	Autonomy	proportion of completed procedure not requiring human intervention	6 weeks from enrolment
Primary	Walk-away time	time savings realized by an embryologist who is able to attend other duties while the robotic assistant is at work	6 weeks from enrolment
Secondary	Sperm survival and quality (seminogram)		6 weeks from enrolment
Secondary	Proportion of oocytes fertilized		6 weeks from enrolment
Secondary	Embryos survival and quality (by morphology assessment)		6 weeks from enrolment
Secondary	Clinical pregnancy rates following embryo transfer		8 weeks from enrolment