Recruiting

Mindset Management

Sponsor:

Virginia Polytechnic Institute and State University

Code:

NCT05997407

Conditions

Stress

Infertility, Female

Eligibility Criteria

Sex: Female

Age: 18 - 42

Healthy Volunteers: Not accepted

Interventions

Organic Conceptions mindset management program

Study Details

Brief summary:

The goal of this clinical trial is to test the effect of a mindset management intervention on stress levels in women with infertility. The main question it aims to answer is:

Can the Organic Conceptions approach decrease stress levels in women with infertility?

Participants in both groups will be asked to complete three surveys at three time points. The intervention group will complete the Organic Conceptions program, while the control group will not complete an intervention.

Researchers will compare the intervention group and control group to see if the Organic Conceptions mindset management program decreases stress levels in women with infertility.

Conditions

Stress

Infertility, Female

Study ID

NCT05997407

Start date

Nov 10, 2023

Status verified date

Aug, 2025

Completion date

Dec, 2026

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 42

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Speaks and reads English
  • New patient at Shady Grove Fertility in Roanoke or Richmond
  • Access to smartphone, tablet, or computer, and internet

Exclusion Criteria:

  • Has seen a fertility specialist (reproductive endocrinologist) before AND underwent fertility treatment under that provider
  • Is currently engaging with the Organic Conceptions method

Study Design

Enrollment

66 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Other

Interventions and Outcome Measures

Arms

experimental: Organic Conceptions intervention group

Will complete Organic Conceptions intervention.

no intervention: Control group

Will not complete Organic Conceptions intervention.

Interventions

Organic Conceptions mindset management program

Organic Conceptions is a theoretical model and corresponding 9-step cognitive-based therapy program that enables people to understand where they are in their fertility journey, and provides them with coping strategies to reframe the painful emotional side effects of infertility. In addition to the 9-step program, there are mini-classes on the key triggers that people face when dealing with infertility.

The intervention consists of a series of assignments that participants in the intervention group will complete for a ten-week period. These assignments will take approximately three hours per week to complete. In addition, participants will complete biweekly live support group sessions led by certified coaches and will have the option to join a Facebook support group.

Primary outcome measure

  • Stress levels in women with infertility [ Time Frame: Day 0, end of week 10 (day 70), end of week 16 (day 112) ]

Central Contacts and Locations

Central contacts

Emily Evans-Hoeker, MD

(844) 205- 3246Emily.Evans-Hoeker@sgfertility.com

Locations

Shady Grove Fertility

Recruiting

Roanoke, Virginia, United States, 24018

Contacts

Emily Evans-Hoeker, MD

844-205-3246

More Information

Sponsor

Virginia Polytechnic Institute and State University

Last update posted

Sep 10, 2025

Last verified

Aug, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Virginia Polytechnic Institute and State University on 2025-09-10.