An observational study in Sperm Classification, sponsored by BAIBYS Fertility. Active, not recruiting at 1 site in United States. Open to male participants aged 22 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-07-23.
Sponsored by BAIBYS Fertility · Observational
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).
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.
BAIBYS Fertility is the lead sponsor of 2 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
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].
Exclusion Criteria:
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.
Time frame: Each semen sample will be recorded for 10 minutes
Plan to share: Yes — 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.
Supporting information: Study protocol, Csr
No publications or documents are linked to this record.
This study is active, not recruiting, as verified in Jul 2024. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
BAIBYS Fertility