NCT03085212: SPA

Strategies for Pregnancy Achievement

Active, enrolled NA Last updated 15 April 2026

What this trial tests

NA trial testing Stress Free Now in Fertility Disorders in 40 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

21 May 2017

Primary endpoint
3 April 2019

31 December 2026

Quick facts

Lead sponsor	Courtney D.Lynch, PhD MPH
Phase	NA
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	40
Start date	21 May 2017
Primary completion	3 April 2019
Estimated completion	31 December 2026
Sites	1 location across United States

Drugs / interventions tested

• Stress Free Now

Conditions studied

• Fertility Disorders — all drugs for Fertility Disorders →
• Psychological Stress — all drugs for Psychological Stress →
• Infertility — all drugs for Infertility →
• Infertility, Female — all drugs for Infertility, Female →

Sponsor

Courtney D.Lynch, PhD MPH

Who can join

Adults 18 to 34, female only, with Fertility Disorders or Psychological Stress. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.