Clinical trial NCT06150846: Sperm Video Recording Protocol
Official title: Sperm Video Recording Protocol
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Sperm Classification
Keywords: Sperm
Artificial Inteligence
Lead sponsor: BAIBYS Fertility
Sponsor class: INDUSTRY
First posted: 2023-11-29
Enrollment: 40
Sex: MALE
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
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 \[characteristics of ethnic and racial diversity, BMI diversity, and normal (\> WHO 5%ile cutoffs) versus abnormal morphology\].

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.

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

Primary outcomes:
measure: Obtaining 6,000 classified sperm images
timeFrame: Each semen sample will be recorded for 10 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Vienna
country: United States
facility: CCRM Northern Virginia
state: Virginia
Study officials:
affiliation: CCRM Fertility Clinic and IVF Clinic
name: Carter Owen, M.D.
role: PRINCIPAL_INVESTIGATOR
References: