An interventional study of Frame Access in Fertility Issues and Emotional Stress, sponsored by Inception Fertility Research Institute, LLC. Recruiting at 1 site in United States. Open to female participants aged 22 Years to 44 Years. Per ClinicalTrials.gov, last updated 2026-04-15.
Sponsored by Inception Fertility Research Institute, LLC · Not applicable, Interventional, and Supportive care
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Among 10 studies in Infertility by Inception Fertility Research Institute, LLC — 5 open to participants now, 5 under way, none of them phase 3. Infertility · Inception Fertility Research Institute, LLC.
Among the 10 studies in Infertility by Inception Fertility Research Institute, LLC, this one is one of 2 that started in 2025, is one of 2 with no phase, and was the 6th registered.
2,088 studies on the registry are indexed under Infertility; 356 are open to participants now.
Browse Infertility studies →5 of the 10 studies in Infertility by Inception Fertility Research Institute, LLC are open now, in 1 country. Recruiting first, the newest first:
Inception Fertility Research Institute, LLC · Sites in United States
Women only
Inception Fertility Research Institute, LLC · Sites in United States
Ages 18–37 · Women only
Inception Fertility Research Institute, LLC · Sites in United States
Inception Fertility Research Institute, LLC
Women only
By country, each count listing its studies:
Of the 234 Infertility studies recruiting now, 43 (18%) set no upper age limit and 185 (79%) stop at 75 or younger; 27 take children under 18; 76 take healthy volunteers.
This study: 22 Years to 44 Years · female · no healthy volunteers.
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10 studies; the count open now beside each. This study's row is marked.
First in 2023; this study’s year is marked. 2 started in 2025.
This study's planned enrollment of 400 is above the median of 134 across 1,414 interventional studies indexed under Infertility.
Median enrollment 220 across the 2 interventional studies, 420 across the 8 observational. Of the 5 that completed or were terminated, 0 (0%) have results posted.
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Inception Fertility Research Institute, LLC is the lead sponsor of 12 studies on the registry; 5 are open to participants now.
3 of the studies in Infertility by Inception Fertility Research Institute, LLC that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07083700Inception Fertility Research Institute, LLCFrame Support Study | 2026-12 |
| NCT07666243Inception Fertility Research Institute, LLCOutcomes of Embryos Created From Abnormally Fertilized Oocytes | 2027-06 |
| NCT07725458Inception Fertility Research Institute, LLCPatient Empowerment Project (PEP) Study | 2027-08 |
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Among the 10 studies in Infertility by Inception Fertility Research Institute, LLC, from their registry updates:
Nothing recorded among them since 2026-09-25.
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This is a randomized, controlled pilot study evaluating an intervention of non-significant risk. Potential subjects will be women who have completed an initial new patient consultation at one of the participating fertility clinics. Approximately 400 subjects will be enrolled from multiple fertility clinics.
All participants will complete a psychological questionnaire at enrollment. The questionnaire will include the Perceived Stress Scale (PSS), the Personal Health Questionnaire Depression Scale (PHQ-8), and the Copenhagen Multi-Centre Psychosocial Infertility- Fertility Problem Stress Scale (COMPI-FPSS). Participants will then be randomized 1:1 to the control group or intervention group. Participants in the control group will not be asked to take any additional action for six months. Participants in the intervention group will be given access to FRAME which will provide them with resources and an external care team to utilize during their fertility care. The intervention group is encouraged to use FRAME and its resources for six months. After six months, participants in both groups will complete a post-study psychological questionnaire. Data will be collected from medical records of all participants for up to nine months after enrollment.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Behavioral: Frame Access
FRAME™ provides a collaborative care platform that connects patients with evidence-based resources, education and support from a dedicated care team throughout their reproductive health care journey. More specifically, for patients exploring fertility treatment. Frame supplements the patient experience by providing patients with direct contact to board-certified fertility coaches and resources that can be accessed between appointments in a web-based application. Regular use of Frame's platform may help patients make lifestyle changes that can improve their fertility outcomes as well as boost their emotional health throughout the treatment process and reduce feelings of overwhelm and loneliness which can lead to patients dropping out of care.
Fertility treatment initiation
To observe whether the patient started fertility treatment.
Time frame: This will be evaluated at the end of patient's study participation, approximately 6 months post enrollment.
Time to fertility treatment initiation
To observe the interval between study enrollment and start fertility treatment, if any.
Time frame: This will be evaluated at the end of patient's study participation, approximately 6 months post enrollment.
Patient Health Questionnaire (PHQ-8)
Patients will complete the Patient Health Questionnaire (PHQ-8) for depression screening at baseline and end of study. Scores of 10 and above suggest the presence of Major Depressive Disorder with higher scores being more severe.
Time frame: From enrollment to six months after enrollment
Copenhagen Multi-Centre Psychosocial Infertility- Fertility Problem Stress Scale (COMPI-FPSS)
Patients will complete the Copenhagen Multi-Centre Psychosocial Infertility- Fertility Problem Stress Scale (COMPI-FPSS) at baseline and end of study. Lower scores indicate lower stress.
Time frame: From enrollment to 6 months after enrollment.
Perceived Stress Scale (PSS-10)
Patients will complete the Perceived Stress Scale (PSS-10) at baseline and end of study. Scores will be interpreted as 0-13: Low stress; 14-26: Moderate stress; 27-40: High perceived stress.
Time frame: From enrollment to 6 months after enrollment.
Plan to share: No
No publications or documents are linked to this record.
Started Jun 2025 (actual). Primary completion is estimated for Dec 2026, 18 months after the start.
Of 31 industry-sponsored interventional studies with no phase under Infertility, half reached primary completion within 27 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 34. This study's planned 18 months is below that.
Counting every sponsor, half of 417 studies reached it within 24 months; a quarter within 10 and three quarters within 43.
How these figures are worked out, and which studies are left out of them.
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