Sperm Video Recording Protocol

Status unconfirmed

Conditions studied: Sperm Classification

In brief

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).

Key facts

Study ID

NCT06150846

Run by

BAIBYS Fertility

People needed

40

Starts

2023-12-01

Expected to finish

2024-08-01

Last updated by the study team

2024-07-23

Who can join

Age: 22 and older. Sex: male. Healthy volunteers: accepted.

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

Where it is running

• CCRM Northern Virginia — Vienna, Virginia, United States

Full record on ClinicalTrials.gov

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