Sperm Video Recording Protocol

NCT ID: NCT06150846

Last Updated: 2024-07-23

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 40 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-12-01
• Study Completion Date: 2024-08-01

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).

Detailed Description

The study will obtain video clips of 40 male subjects semen sample at high magnification. Each subject contributes 1 sample from which 10 minutes of video is recorded.

A total of 720,000 frames are expected to be collected at 30 frames per second. At least 6,000 frames will be selected at random from these 10,800-14,500 frames to be labeled by at least two embryologists. The sperm morphology will be rated according to the Kruger criteria per the WHO 6th edition. The data collected will be utilized to train the Artificial Intelligence (AI) used within the BAIBYS System.

Conditions

Sperm Classification

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: CROSS_SECTIONAL

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 22 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

BAIBYS Fertility

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Carter Owen, M.D.

Role: PRINCIPAL_INVESTIGATOR

CCRM Fertility Clinic and IVF Clinic

Locations

CCRM Northern Virginia

Vienna, Virginia, United States

Countries

United States

Other Identifiers

BCP-002 Sperm VR Trial

Identifier Type: -

Identifier Source: org_study_id