Stress Level and the Relationship With IVF Outcomes.

Infertility Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02638662
• Other study ID #: 0903010295
• Status: Completed
• Start date: July 2010
• Est. completion date: February 29, 2020

Study information

• Verified date: June 2020
• Source: Weill Medical College of Cornell University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The effect of stress on IVF outcomes.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 276
• Est. completion date: February 29, 2020
• Est. primary completion date: October 30, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 44 Years

Eligibility

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)

Related Conditions & MeSH terms

• Infertility

Intervention

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

Locations

Country	Name	City	State
United States	Weill Cornell Medical College	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Weill Medical College of Cornell University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Biomarkers Cortisol and adrenocorticotropic hormone ACTH.		28-35 days
Secondary	Questionnaires to be completed are Life Orientation Test-R		28-35 days
Secondary	Self- Evaluation Questionnaire (STAI)	Questionnaire	28-35 days
Secondary	FertiQOL International		28-35 days
Secondary	Beck Depression Inventory	Questionnaire	28-35 days
Secondary	Daily Stress Questionnaire	Questionnaire	28-35 days