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NCT03085212 · ClinicalTrials.gov registry record · NA

Strategies for Pregnancy Achievement

A NA study of Infertility and Infertility, Female, sponsored by Courtney D.Lynch, PhD MPH.

Active
Registry status
NA
Development phase
40
Enrollment target
1
Study location

NCT03085212 is a NA study of Infertility and Infertility, Female that is active but no longer recruiting, run by Courtney D.Lynch, PhD MPH. The registered enrollment target is 40 participants, below the 7,589-participant average among 74 other Infertility trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT03085212, a NA study of Infertility and Infertility, Female, is active but no longer recruiting, sponsored by Courtney D.Lynch, PhD MPH.

ACTIVE NOT RECRUITING
Registry status
NA
Development phase
40 participants
Enrollment target
1
Study location

Study Summary

The purpose of pilot study application is to build on the investigators' previous work that established the prospective association between stress and infertility. Specifically, the investigators hope to collect the preliminary data necessary to make them competitive to submit a R01 application to NIH for funding of a full-scale randomized controlled trial of an internet-based stress management program to examine its efficacy in decreasing stress and increasing pregnancy rates among women who have tried to get pregnant for 6-12 months without success. The program called Stress Free Now (SFN) was developed at the Cleveland Clinic and has been shown to be effective in lowering stress in a variety of populations. The program introduces concepts of mindfulness and cognitive-behavioral therapy to assist individuals in managing their stress levels. The intervention includes Internet-based interaction, daily emails and recommended relaxation practice of at least four days per week. Using targeted Facebook Ads and other recruitment modalities, the investigators will randomize 40 women ages 18-34 who have been trying to conceive for 6-12 months without success. The PI has been enrolling women in a similar study using this mechanism and has found it to be an efficient and cost-effective method of identifying potentially eligible individuals. Women will be randomized to SFN or a wait list control condition and will be followed for up to three months post-randomization with weekly journals as they try to conceive. The primary outcome of this randomized controlled trial is stress level, as measured by salivary alpha-amylase, while the secondary outcome will be pregnancy rate at the end of the three-month follow-up period.

Interventions

  • BEHAVIORAL Stress Free Now

Study Locations (1)

Ohio

  • The Ohio State University College of Medicine - Columbus

Trial Details

FieldValue
Enrollment Target 40 participants
Start Date 2017-05-21
Est. Completion 2026-12-31
Phase NA

Sponsor

Courtney D.Lynch, PhD MPH

2 total trials

What the Registry Record Tells You About NCT03085212

The ClinicalTrials.gov registry entry for NCT03085212 describes a study currently listed as active not recruiting, categorized as NA. The registered enrollment target is 40 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 7,589-participant average among 74 other Infertility trials with a reported enrollment target (99% lower). The listed sponsor is Courtney D.Lynch, PhD MPH, which has 2 total studies on file at ClinicalTrials.gov.

The record links to 4 conditions, with Infertility appearing as the primary indexed condition, and to 1 intervention - of which Stress Free Now is the first listed.

NCT03085212 reports 1 study location spanning 1 distinct geographic area - top geographies include Ohio.

Frequently Asked Questions

What is clinical trial NCT03085212 about?

NCT03085212 is a clinical study titled "Strategies for Pregnancy Achievement". The purpose of pilot study application is to build on the investigators' previous work that established the prospective association between stress and infertility. Specifically, the investigators hope to collect the preliminary data necessary to make them competitive to submit a R01 application to N...

What is the current status of trial NCT03085212?

This trial is currently active not recruiting. It is a NA study. The enrollment target is 40 participants. The study started on 2017-05-21. Estimated completion is 2026-12-31.

What conditions does trial NCT03085212 study?

This clinical trial studies the following conditions: Infertility, Infertility, Female, Psychological Stress, Fertility Disorders.

What interventions are being tested in trial NCT03085212?

The interventions under investigation include: Stress Free Now (BEHAVIORAL).

Who is sponsoring clinical trial NCT03085212?

This trial is sponsored by Courtney D.Lynch, PhD MPH, which has 2 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT03085212 being conducted?

This trial has 1 study location across Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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