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

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. According to ClinicalTrials.gov, the official US trial registry.

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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.

Primary Outcome

A salivary specimen will be collected to measure salivary alpha-amylase

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
Courtney D.Lynch, PhD MPH

2 total trials

What the registry record for NCT03085212 still lists

NCT03085212 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 7,589-participant average among 74 other Infertility trials with a reported enrollment target (99% lower).

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 a single indexed study location in 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.

Similar trials for Infertility

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT03085212's enrollment target sits among peer trials

40 65th of 74 higher than 8 of 74 other Infertility trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Infertility trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT03085212, the US trial registry maintained by the National Library of Medicine. NCT03085212 (small enrollment · single site footprint · active not recruiting) retrieved and formatted by PlainTrial, see methodology.