NCT02638662

Brief Summary

The effect of stress on IVF outcomes.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
276

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2010

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2010

Completed
5.3 years until next milestone

First Submitted

Initial submission to the registry

October 6, 2015

Completed
3 months until next milestone

First Posted

Study publicly available on registry

December 23, 2015

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2018

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 29, 2020

Completed
Last Updated

June 25, 2020

Status Verified

June 1, 2020

Enrollment Period

8.3 years

First QC Date

October 6, 2015

Last Update Submit

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.

Other: Observational

Donors Observational

Those who are doing IVF for the sole purpose of donating their eggs.

Other: Observational

2 or more IVF cycles Obervational

Those who have done IVF 2 or more times with no success.

Other: Observational

Interventions

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

2 or more IVF cycles ObervationalDonors ObservationalFirst time IVF patients. Observational

Eligibility Criteria

Age20 Years - 44 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
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

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

Location

MeSH Terms

Conditions

Infertility

Interventions

Watchful Waiting

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Intervention Hierarchy (Ancestors)

Outcome Assessment, Health CareOutcome and Process Assessment, Health CareQuality of Health CareHealth Services Administration

Study Officials

  • Steven Spandorfer, MD

    Weill Medical College of Cornell University

    PRINCIPAL INVESTIGATOR

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

Locations