Stress Level and the Relationship With IVF Outcomes.

Does Stress Affect In-Vitro Fertilization (IVF) Outcome?

The effect of stress on IVF outcomes.

Study Overview

• Status: Completed
• Conditions: Infertility
• Intervention / Treatment: Other: Observational

Detailed Description

The purpose of this study is to describe the pattern of psychological distress (depression, anxiety and stress) as assessed by both subjective and objective measures throughout the course of IVF treatment and to investigate its impact on IVF outcome.

• Study Type: Observational
• Enrollment (Actual): 276

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10021
      • Weill Cornell Medical College

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 44 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

IVF patients doing IVF for the first time, or doing it for the third or more time doing it for the sole purpose to donate their eggs

Description

Inclusion Criteria:

• Healthy women undergoing IVF at CRMI Ages 20-44

Patients will be divided in different groups depending on whether:

1. They are donating oocytes (control group).
2. They are undergoing IVF for the first time.
3. They are undergoing IVF for the third time and have either failed or succeeded the prior time.

Exclusion Criteria:

• Any patients who are not candidates for IVF
• Any women who have any past or current medical condition unrelated to their infertility concurrent to their history of infertility (e.g., gastrointestinal disease)

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
First time IVF patients. Observational; Those who are doing IVF for the first time.	Other: Observational; Questionnaires are completed such as self-evaluation questionnaire (STAI), Beck Depression Inventory, FertiQol International and Daily stress questionnaire
Donors Observational; Those who are doing IVF for the sole purpose of donating their eggs.	Other: Observational; Questionnaires are completed such as self-evaluation questionnaire (STAI), Beck Depression Inventory, FertiQol International and Daily stress questionnaire
2 or more IVF cycles Obervational; Those who have done IVF 2 or more times with no success.	Other: Observational; Questionnaires are completed such as self-evaluation questionnaire (STAI), Beck Depression Inventory, FertiQol International and Daily stress questionnaire

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Biomarkers Cortisol and adrenocorticotropic hormone ACTH.	28-35 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Questionnaires to be completed are Life Orientation Test-R		28-35 days
Self- Evaluation Questionnaire (STAI)	Questionnaire	28-35 days
FertiQOL International		28-35 days
Beck Depression Inventory	Questionnaire	28-35 days
Daily Stress Questionnaire	Questionnaire	28-35 days

Collaborators and Investigators

• Sponsor: Weill Medical College of Cornell University

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2010
• Primary Completion (Actual): October 30, 2018
• Study Completion (Actual): February 29, 2020

Study Registration Dates

• First Submitted: October 6, 2015
• First Submitted That Met QC Criteria: December 18, 2015
• First Posted (Estimate): December 23, 2015

Study Record Updates

• Last Update Posted (Actual): June 25, 2020
• Last Update Submitted That Met QC Criteria: June 24, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infertility
• Other Study ID Numbers: 0903010295

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No