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Stress Level and the Relationship With IVF Outcomes.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02638662
Recruitment Status : Completed
First Posted : December 23, 2015
Last Update Posted : June 25, 2020
Sponsor:
Information provided by (Responsible Party):
Weill Medical College of Cornell University

Brief Summary:
The effect of stress on IVF outcomes.

Condition or disease Intervention/treatment
Infertility 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.

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Study Type : Observational
Actual Enrollment : 276 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Does Stress Affect In-Vitro Fertilization (IVF) Outcome?
Actual Study Start Date : July 2010
Actual Primary Completion Date : October 30, 2018
Actual Study Completion Date : February 29, 2020

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




Primary Outcome Measures :
  1. Biomarkers Cortisol and adrenocorticotropic hormone ACTH. [ Time Frame: 28-35 days ]

Secondary Outcome Measures :
  1. Questionnaires to be completed are Life Orientation Test-R [ Time Frame: 28-35 days ]
  2. Self- Evaluation Questionnaire (STAI) [ Time Frame: 28-35 days ]
    Questionnaire

  3. FertiQOL International [ Time Frame: 28-35 days ]
  4. Beck Depression Inventory [ Time Frame: 28-35 days ]
    Questionnaire

  5. Daily Stress Questionnaire [ Time Frame: 28-35 days ]
    Questionnaire



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 44 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02638662


Locations
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United States, New York
Weill Cornell Medical College
New York, New York, United States, 10021
Sponsors and Collaborators
Weill Medical College of Cornell University
Investigators
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Principal Investigator: Steven Spandorfer, MD Weill Cornell Medicine
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Responsible Party: Weill Medical College of Cornell University
ClinicalTrials.gov Identifier: NCT02638662    
Other Study ID Numbers: 0903010295
First Posted: December 23, 2015    Key Record Dates
Last Update Posted: June 25, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Infertility
Genital Diseases, Male
Genital Diseases, Female