Sperm Video Recording Protocol

NCT06150846 | Active Not Recruiting

• 1 other identifier: BCP-002 Sperm VR Trial
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to obtain anonymous video clips of male semen at high magnification, to manually select out of the video spermatozoon images, and to manually classify their morphology by qualified embryologists based on the WHO Manual criteria in order to train the BAIBYS™ Fertility System. The study will enroll males attending the clinic who may elect to contribute their unused excess sample materials from semen analysis or IVF/ICSI (Intracytoplasmic sperm injection) which is a technique used during in vitro fertilization (IVF).

Conditions

Sperm Classification

Keywords

Sperm; Artificial Inteligence

Outcome Measures

Primary Outcomes (1)

• Obtaining 6,000 classified sperm images

  Obtaining 6,000 sperm images classified each by at least 2 embryologist based on the WHO 6th edition criteria to add to the AI training of the Baibys system.

  Each semen sample will be recorded for 10 minutes

Eligibility Criteria

• Age: 22 Years+
• Gender Eligibility Details: Assigned male at birth and possessing typical male anatomy (i.e., one or two testicles and penis)
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study will enroll 30-40 male subjects attending the clinic and willing to contribute their unused excess sample materials from semen analysis or IVF/ICSI. Enrollment will include three sub-populations of at least 15 patients to ensure diversity \[characteristics of ethnic and racial diversity, BMI diversity, and normal (\> WHO 5%ile cutoffs) versus abnormal morphology\].

You may qualify if:

• Assigned male at birth and possessing typical male anatomy (i.e., one or two testicles and penis)
• Scheduled to produce a semen sample for fertility evaluation
• Able to produce a semen sample, including, in the judgement of the PI, ability to follow instructions provided in English by the physician or physician's team members
• At least a 10th grade education level, to be able to read and understand the ICF; evaluated by either completion of 10th grade, or by any higher level of education or GED
• Age 22 or older at the time of consent

You may not qualify if:

• Known azoospermia prior to semen analysis.
• Subjects with azoospermia or otherwise inadequate sample discovered during the trial will be compensated for their participation in recognition of their efforts to contribute to science, but will be replaced with an additional subject for the data collection and labeling to reach a total sample of up to 40 videos
• History of chemotherapy or radiation within prior 12 months, due to increased chance of azoospermia
• Developmental delays or other neurological impairment that could impair ability to freely consent, as evaluated by the PI
• Any reason why in the sole judgement of the PI, consent to participate cannot be freely given

Sponsors & Collaborators

• BAIBYS Fertility: lead

Study Sites (1)

CCRM Northern Virginia

Vienna, Virginia, 22182, United States

Location

Study Officials

• Carter Owen, M.D.

  CCRM Fertility Clinic and IVF Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 21, 2023
• First Posted: November 29, 2023
• Study Start: December 1, 2023
• Primary Completion: August 1, 2024
• Study Completion: August 1, 2024
• Last Updated: July 23, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR
• Time Frame: 12 months after follow up pivotal trial is completed
• Access Criteria: The IPD will be anonymized and shared as described in the plan. All those getting access will not be able to de-identify any patient's data. Anonymized patient's data including selection of sperm images/videos will be used together with the clinical study report and protocol will be shared to the medical writer and the supervisor author for the purpose of the the final publication.

Locations

US (1)