An interventional study of AI to analyze 3 D ultrasound in Infertility, in Vitro Fertilization (IVF) and ART, sponsored by Weill Medical College of Cornell University. Recruiting at 1 site in United States. Open to participants aged 18 Years to 89 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-12-24.
Sponsored by Weill Medical College of Cornell University · Not applicable, Interventional, and Other
The use of machine learning techniques using an artificial intelligence tool is proposed to analyze clinical data to predict best possible IVF/ART outcomes. This tool has been utilized to accurately predict embryo quality here at Cornell. Utilizing this tool to assess objective clinical findings and predict outcomes of assisted reproductive techniques is sought, with the ultimate goal of an automated tool to reduce implicit physician bias. Within this goal, using this tool to objectively and accurately assess baseline ovarian reserve at the start of an ART cycle is proposed, using 3D sonography to image the ovary and artificial intelligence tool to objectively identify baseline antral follicle counts.
This study will collect prospective data, specifically 3D transvaginal ultrasound of ovaries at time of baseline evaluation at beginning of an ART cycle. All participants will be asked to give written consent to be included in the study. At the time of initial ultrasound that is routinely done on the first day of the ART cycle, the physician performing the ultrasound will use a 3D ultrasound transvaginal probe to perform the ultrasound and capture both 2D and 3D images. 3D ultrasound is performed routinely for patients undergoing ART and is not an investigative procedure, however is not uniformly performed at the time of the baseline ultrasound. As per standard practice, the baseline antral follicle count will be documented by the performing physician, as well as a 3D image saved to be analyzed later using AI.
Information about the medical history, treatment and outcomes will be collected as part of the study. Data maintained in the medical record as a result of standard of care monitoring for IVF and IUI will also be used for this study. This will include semen analysis (male partners if applicable) and pregnancy outcomes. For male partners, the semen analysis record will be part of the fertility history and semen analysis will be performed as standard of care with semen processing for fertilization. Additional data related to the treatment and outcomes will be collected from the medical record from the time of consent through the end of the treatment (including pregnancy outcomes).
The time commitment for subjects may take up to 1 month (time from consent signing to 3D ultrasound) and to the time of delivery if pregnant (up to 9 months). No further procedures will be performed in the study group.
2,506 studies on the registry are indexed under Infertility; 407 are open to participants now.
This study's planned enrollment of 4,000 is above the median of 120 across 1,698 interventional studies indexed under Infertility.
Browse Infertility studies →Weill Medical College of Cornell University is the lead sponsor of 867 studies on the registry; 160 are open to participants now.
Of its 119 completed or terminated interventional studies of FDA-regulated products, 91 (76%) have results posted.
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Exclusion Criteria:
AI tool to assess antral follicle count using 3 D Ultrasound
Other: AI to analyze 3 D ultrasound
AI to assess 3 D ultrasound to assess antral follicle count
Also known as: z
Number of baseline antral follicle count
To assess the accuracy and feasibility of using our artificial intelligence tool to assess antral follicle count, an indicator of baseline ovarian reserve, at time of baseline ultrasound for ART compared to qAVCantral and manual follicle counts to number of total oocytes retrieved.
Time frame: Baseline
Number of retrieved oocytes
To assess the accuracy and feasibility of using our artificial intelligence tool
Time frame: 2 weeks
Number of mature oocytes
Number of mature oocytes (ART cycles)
Time frame: 2 weeks
Number of multiple gestation
Number of multiple gestation for OI cycles.
Time frame: approximately 6- 8 weeks
Number of clinical intrauterine pregnancies IVF
Clinical intrauterine pregnancies
Time frame: approximately 6- 8 weeks
Number of clinical intrauterine pregnancies OI
Clinical intrauterine pregnancies
Time frame: Approximately 6- 8 weeks
Plan to share: No
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Weill Medical College of Cornell University