InfertilityNCT02638662
Stress Level and the Relationship With IVF Outcomes.
An observational study of Infertility, run by Weill Medical College of Cornell University at 1 site in United States.
Trial summary
The effect of stress on IVF outcomes. Read more about this study
- Who is it for?
- Ages 20 to 44 years, women only
- Conditions the study is for
- Infertility
- What is being tested?
- Observational
- How many people
- 276 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2010to 29 Feb 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 44 years
- Women only
- No healthy volunteers
- Adult
Study population: 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
Who may be able to join
- 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.
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
Weill Cornell Medical College
New York, New York, 10021
About this study
Official title: Does Stress Affect In-Vitro Fertilization (IVF) Outcome?
The effect of stress on IVF outcomes.
Read the 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.
- Conditions
- Infertility
- Being tested
- Observational
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ObservationalOther
Questionnaires are completed such as self-evaluation questionnaire (STAI), Beck Depression Inventory, FertiQol International and Daily stress questionnaire
| Study group | Role | What they receive |
|---|---|---|
| First time IVF patients. Observational | Those who are doing IVF for the first time. Receives: Other: Observational | |
| Donors Observational | Those who are doing IVF for the sole purpose of donating their eggs. Receives: Other: Observational | |
| 2 or more IVF cycles Obervational | Those who have done IVF 2 or more times with no success. Receives: Other: Observational |
What is being measured
The primary outcome is the main question the study is designed to answer.
Biomarkers Cortisol and adrenocorticotropic hormone ACTH.
Measured: 28-35 days
Secondary outcomes (5)
Questionnaires to be completed are Life Orientation Test-R
Measured: 28-35 days
Self- Evaluation Questionnaire (STAI)
Questionnaire
Measured: 28-35 days
FertiQOL International
Measured: 28-35 days
Beck Depression Inventory
Questionnaire
Measured: 28-35 days
Daily Stress Questionnaire
Questionnaire
Measured: 28-35 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2015 (estimated)
- Study startJul 2010
- Primary completion30 Oct 2018
- Study completion29 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfertilityStudies of the same condition, open and under way.
- More trials run by Weill Medical College of Cornell UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 276 participants (actual)
Sponsor and investigators
- Lead sponsor
- Weill Medical College of Cornell University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Steven Spandorfer, MD, Principal investigator, Weill Medical College of Cornell University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02638662
- Sponsor's protocol ID
- 0903010295
- Status last verified
- Jun 2020
- First submitted
- 6 Oct 2015
- Last updated
- 25 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Stress Affect In-Vitro Fertilization (IVF) Outcome?
- ClinicalTrials.gov ID
- NCT02638662
- Acronym / sponsor ID
- 0903010295
- Conditions
- Infertility
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 276 participants (actual)
- Lead sponsor
- Weill Medical College of Cornell UniversityUniversity, hospital or other
- Study start
- Jul 2010 (actual)
- Primary completion
- 30 Oct 2018 (actual)
- Study completion
- 29 Feb 2020 (actual)
- First posted
- 23 Dec 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| First time IVF patients. Observational | – | Other: ObservationalThose who are doing IVF for the first time. |
| Donors Observational | – | Other: ObservationalThose who are doing IVF for the sole purpose of donating their eggs. |
| 2 or more IVF cycles Obervational | – | Other: ObservationalThose who have done IVF 2 or more times with no success. |
Who may qualify
- Ages
- 20 to 44 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- 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
Key inclusion criteria (5 listed)
- Healthy women undergoing IVF at CRMI Ages 20-44
- 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.
Key exclusion criteria (2 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ObservationalQuestionnaires are completed such as self-evaluation questionnaire (STAI), Beck Depression Inventory, FertiQol International and Daily stress questionnaire | Other | 2 or more IVF cycles Obervational, Donors Observational, First time IVF patients. Observational |
Primary outcome
Biomarkers Cortisol and adrenocorticotropic hormone ACTH.
Time frame: 28-35 days
5 secondary outcomes
Questionnaires to be completed are Life Orientation Test-R
Time frame: 28-35 days
Self- Evaluation Questionnaire (STAI)
Time frame: 28-35 days
FertiQOL International
Time frame: 28-35 days
Beck Depression Inventory
Time frame: 28-35 days
Daily Stress Questionnaire
Time frame: 28-35 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Steven Spandorfer, MD principal investigator
Weill Medical College of Cornell University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Infertility, run by Weill Medical College of Cornell University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Biomarkers Cortisol and adrenocorticotropic hormone ACTH. (time frame: 28-35 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2020.