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OpenTrials
Completed

NCT Number: NCT02638662

Stress Level and the Relationship With IVF Outcomes.

The effect of stress on IVF outcomes.

Completed

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Key information

Conditions

Infertility Genital Diseases Urogenital Diseases

Age range

20 year–44 year

Sex eligibility

Female

Study type

Observational

Primary location

Weill Cornell Medical College

New York, 10021, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Healthy women undergoing IVF at CRMI Ages 20-44

Patients will be divided in different groups depending on whether:

  • They are donating oocytes (control group).
  • They are undergoing IVF for the first time.
  • 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)

Treatment and study plan

Observational

Other

Questionnaires are completed such as self-evaluation questionnaire (STAI), Beck Depression Inventory, FertiQol International and Daily stress questionnaire

Primary outcomes

  1. Biomarkers Cortisol and adrenocorticotropic hormone ACTH.

    Time frame: 28-35 days

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Weill Medical College of Cornell University

Other

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2018
Study completion
2020
First posted
Dec 23, 2015
Registry last updated
Jun 25, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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