Stress Level and the Relationship With IVF Outcomes.
Does Stress Affect In-Vitro Fertilization (IVF) Outcome?
1 other identifier
observational
276
1 country
1
Brief Summary
The effect of stress on IVF outcomes.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jul 2010
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2010
CompletedFirst Submitted
Initial submission to the registry
October 6, 2015
CompletedFirst Posted
Study publicly available on registry
December 23, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 30, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
February 29, 2020
CompletedJune 25, 2020
June 1, 2020
8.3 years
October 6, 2015
June 24, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Biomarkers Cortisol and adrenocorticotropic hormone ACTH.
28-35 days
Secondary Outcomes (5)
Questionnaires to be completed are Life Orientation Test-R
28-35 days
Self- Evaluation Questionnaire (STAI)
28-35 days
FertiQOL International
28-35 days
Beck Depression Inventory
28-35 days
Daily Stress Questionnaire
28-35 days
Study Arms (3)
First time IVF patients. Observational
Those who are doing IVF for the first time.
Donors Observational
Those who are doing IVF for the sole purpose of donating their eggs.
2 or more IVF cycles Obervational
Those who have done IVF 2 or more times with no success.
Interventions
Questionnaires are completed such as self-evaluation questionnaire (STAI), Beck Depression Inventory, FertiQol International and Daily stress questionnaire
Eligibility Criteria
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
You may qualify if:
- 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.
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Weill Cornell Medical College
New York, New York, 10021, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Steven Spandorfer, MD
Weill Medical College of Cornell University
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 6, 2015
First Posted
December 23, 2015
Study Start
July 1, 2010
Primary Completion
October 30, 2018
Study Completion
February 29, 2020
Last Updated
June 25, 2020
Record last verified: 2020-06
Data Sharing
- IPD Sharing
- Will not share