Stress Level and the Relationship With IVF Outcomes.

• Sponsor: Weill Medical College of Cornell University (Other)
• Overall Status: Completed
• CT.gov ID: NCT02638662
• Collaborator: (none)
• Enrollment: 276
• Location: 1
• Actual Duration (Months): 116
• Patients Per Site Per Month: 2.4

Study Details

Study Description

Brief Summary

The effect of stress on IVF outcomes.

Condition or Disease	Intervention/Treatment	Phase
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.

Study Design

• 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: Jul 1, 2010
• Actual Primary Completion Date: Oct 30, 2018
• Actual Study Completion Date: Feb 29, 2020

Arms and Interventions

Arm	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

Outcome Measures

Primary Outcome Measures

1. Biomarkers Cortisol and adrenocorticotropic hormone ACTH. [28-35 days]

Secondary Outcome Measures

1. Questionnaires to be completed are Life Orientation Test-R [28-35 days]

2. Self- Evaluation Questionnaire (STAI) [28-35 days]

   Questionnaire

3. FertiQOL International [28-35 days]

4. Beck Depression Inventory [28-35 days]

   Questionnaire

5. Daily Stress Questionnaire [28-35 days]

   Questionnaire

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 44 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Weill Cornell Medical College	New York	New York	United States	10021

Sponsors and Collaborators

• Weill Medical College of Cornell University

Investigators

• Principal Investigator: Steven Spandorfer, MD, Weill Medical College of Cornell University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Weill Medical College of Cornell University
• ClinicalTrials.gov Identifier: NCT02638662
• Other Study ID Numbers: 0903010295
• First Posted: Dec 23, 2015
• Last Update Posted: Jun 25, 2020
• Last Verified: Jun 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Additional relevant MeSH terms: Infertility

Study Results

No Results Posted as of Jun 25, 2020