Stress Level and the Relationship With IVF Outcomes.

Completed

• Conditions: Infertility
• Interventions: Other: Observational

• Registration Number: NCT02638662
• Lead Sponsor: Weill Medical College of Cornell University

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2010-07
• Study First Submitted: 2015-10-06
• Study First Submitted QC: 2015-12-18
• Study First Posted: 2015-12-23
• Primary Completion: 2018-10-30
• Study Completion: 2020-02-29
• Status Verified: 2020-06
• Last Update Submitted: 2020-06-24
• Last Update Posted: 2020-06-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 276

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.

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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)

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
2 or more IVF cycles Obervational	Observational	Those who have done IVF 2 or more times with no success.
First time IVF patients. Observational	Observational	Those who are doing IVF for the first time.
Donors Observational	Observational	Those who are doing IVF for the sole purpose of donating their eggs.

Primary Outcome Measures

Name	Time	Method
Biomarkers Cortisol and adrenocorticotropic hormone ACTH.	28-35 days

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Weill Cornell Medical College; 🇺🇸 New York, New York, United States