Sperm Video Recording Protocol

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).

Study Overview

• Status: Active, not recruiting
• Conditions: Sperm Classification

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.

• Study Type: Observational
• Enrollment (Estimated): 40

Contacts and Locations

Study Locations

• United States
  • Virginia
    • Vienna, Virginia, United States, 22182
      • CCRM Northern Virginia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• 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].

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: BAIBYS Fertility
• Investigators: Principal Investigator: Carter Owen, M.D., CCRM Fertility Clinic and IVF Clinic

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2023
• Primary Completion (Estimated): August 1, 2024
• Study Completion (Estimated): August 1, 2024

Study Registration Dates

• First Submitted: November 21, 2023
• First Submitted That Met QC Criteria: November 21, 2023
• First Posted (Actual): November 29, 2023

Study Record Updates

• Last Update Posted (Actual): July 23, 2024
• Last Update Submitted That Met QC Criteria: July 21, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Keywords: Sperm; Artificial Inteligence
• Other Study ID Numbers: BCP-002 Sperm VR Trial

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing Time Frame: 12 months after follow up pivotal trial is completed

IPD Sharing 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.

• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No