SELF-GYN1 (Sonograms Enable Looking Forward- Get Your iNformation 1 Trial)

Overview

About this study

The purpose of this study is to evaluate the effectiveness and safety of the use of the Turtle Health Ultrasound Scanner for the acquisition of transvaginal ultrasound images by a study participant, with no previous training, in her home when guided by real-time remote supervision from a qualified and specially trained ultrasound technologist.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

  • Woman, as defined by sex at birth.
  • Age 22 years or older at the time of eligibility screening.
  • Premenopausal.
  • BMI < 40 kg/m^2.
  • Unlikely to be pregnant during home scan, based on either current intrauterine device (IUD) or other birth control use or recent menstruation, defined as the home scan occurring between day 3 and 10 of the menstrual cycle based on patient self-report.
  • English-speaking and able to follow verbal instructions of the remote ultrasound. technologist as determined by the ability to complete the consent process unassisted.
  • Ability to manipulate a 1 lb. weight by hand.
  • Residence in state where a PI holds a valid license to practice medicine.
  • Ability to receive signature delivery of the investigational ultrasound device.
  • Ability to return the investigational ultrasound device by specified instructions.

Exclusion Criteria:

  • Pregnant or may be pregnant.
  • Has recently given birth, and has had fewer than 3 postpartum menstrual cycles.
  • Has recently had a stillbirth or abortion more than 20 weeks (subject to the 3 postpartum menstrual cycles above). Miscarriages or abortions less than 20 weeks are subject to two wait cycles.
  • Has changed birth control within the current menstrual cycle (one 'washout' cycle is required).
  • Turtle Health employees.
  • Has known cancer of a pelvic organ, not currently in remission.
  • Not able to schedule a scan while meeting the requirements above prior to the end of the trial. For example, women who change birth control within the last cycle of the trial (and would require a 'washout cycle' that would delay trial close) or who are unable to schedule within the last few weeks of the trial after reasonable scheduling efforts have been made.
  • Previous hysterectomy or oophorectomy.
  • Does not have one or more of the following anatomic organs: vagina, left ovary, right ovary, or uterus.
  • Subjects with prior scanning experience are included in the trial (as they would be in the real world) but excluded from the primary image quality endpoint (due to experience potentially influencing that endpoint) and analyzed separately as a subgroup for that endpoint only. This sub-population is capped at 200 subjects (~20% of trial).

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 10/14/22. Questions regarding updates should be directed to the study team contact.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Alessandra Ainsworth, M.D.

Closed for enrollment

Contact information:

Jainnee Sacksith

(507) 538-5679

Sacksith.Jainnee@mayo.edu

More information

Publications

  • To evaluate noninferiority of virtual transvaginal ultrasonography compared with in-clinic ultrasonography for ovarian reserve assessment. Read More on PubMed
  • The Fertility Assessment and Counseling (FAC) Clinic was initiated to provide women with information about their current fertility status to prevent infertility and smaller families than desired. The aim was to study the predictive value of a risk assessment score based on known fertility risk factors in terms of time to pregnancy. Read More on PubMed
  • To determine the accuracy of transvaginal ultrasonography, sonohysterography and diagnostic hysteroscopy for the investigation of abnormal uterine bleeding in premenopausal women. Read More on PubMed