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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

Tracking Information
First Submitted Date October 6, 2015
First Posted Date December 23, 2015
Last Update Posted Date June 25, 2020
Actual Study Start Date July 2010
Actual Primary Completion Date October 30, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: December 18, 2015)
Biomarkers Cortisol and adrenocorticotropic hormone ACTH. [ Time Frame: 28-35 days ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: December 18, 2015)
  • Questionnaires to be completed are Life Orientation Test-R [ Time Frame: 28-35 days ]
  • Self- Evaluation Questionnaire (STAI) [ Time Frame: 28-35 days ]
    Questionnaire
  • FertiQOL International [ Time Frame: 28-35 days ]
  • Beck Depression Inventory [ Time Frame: 28-35 days ]
    Questionnaire
  • Daily Stress Questionnaire [ Time Frame: 28-35 days ]
    Questionnaire
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Stress Level and the Relationship With IVF Outcomes.
Official Title Does Stress Affect In-Vitro Fertilization (IVF) Outcome?
Brief Summary The effect of stress on IVF outcomes.
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
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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
Condition Infertility
Intervention Other: Observational
Questionnaires are completed such as self-evaluation questionnaire (STAI), Beck Depression Inventory, FertiQol International and Daily stress questionnaire
Study Groups/Cohorts
  • First time IVF patients. Observational
    Those who are doing IVF for the first time.
    Intervention: Other: Observational
  • Donors Observational
    Those who are doing IVF for the sole purpose of donating their eggs.
    Intervention: Other: Observational
  • 2 or more IVF cycles Obervational
    Those who have done IVF 2 or more times with no success.
    Intervention: Other: Observational
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: June 24, 2020)
276
Original Estimated Enrollment
 (submitted: December 18, 2015)
300
Actual Study Completion Date February 29, 2020
Actual Primary Completion Date October 30, 2018   (Final data collection date for primary outcome measure)
Eligibility 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)
Sex/Gender
Sexes Eligible for Study: Female
Ages 20 Years to 44 Years   (Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT02638662
Other Study ID Numbers 0903010295
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Weill Medical College of Cornell University
Study Sponsor Weill Medical College of Cornell University
Collaborators Not Provided
Investigators
Principal Investigator: Steven Spandorfer, MD Weill Cornell Medicine
PRS Account Weill Medical College of Cornell University
Verification Date June 2020