|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
12 December 2020 |
|
Main ID: |
NCT02762461 |
|
Date of registration:
|
28/04/2016 |
|
Prospective Registration:
|
No |
|
Primary sponsor: |
|
|
Public title:
|
Artificial Reproductive Techniques (ART) and Progression of Endometriosis Symptoms
|
|
Scientific title:
|
Artificial Reproductive Techniques (ART) and Progression of Endometriosis Symptoms |
|
Date of first enrolment:
|
February 2016 |
|
Target sample size:
|
154 |
|
Recruitment status: |
Completed |
|
URL:
|
https://clinicaltrials.gov/show/NCT02762461 |
|
Study type:
|
Observational [Patient Registry] |
|
Study design:
|
|
|
Phase:
|
|
|
|
Countries of recruitment
|
|
Denmark
| | | | | | | |
|
Contacts
|
|
Name:
|
Mie Mathiasen, Student |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
University of Aarhus |
| | |
|
Key inclusion & exclusion criteria
|
Inclusion Criteria:
- Female
- < 40 years
- Either undergoing ART (IVF or ICSI) with or without endometriosis or medically treated
endometriosis
Exclusion Criteria:
- > 40 years
Age minimum:
N/A
Age maximum:
40 Years
Gender:
Female
|
|
Health Condition(s) or Problem(s) studied
|
|
Endometriosis
|
|
Intervention(s)
|
|
Procedure: IVF or ICSI
|
|
Primary Outcome(s)
|
|
Endometriosis Health Profile 30® (EHP-30®)
[Time Frame: Groups undergoing ART: Change from baseline measures before stimulation during ART to ten days after aspiration. Reference group not undergoing ART: Change from baseline measures to four weeks later.]
|
|
Secondary Outcome(s)
|
|
Bowel habits
[Time Frame: Groups undergoing ART: Change from baseline measures before stimulation during ART to ten days after aspiration. Reference group not undergoing ART: Change from baseline measures to four weeks later.]
|
|
Pain (NRS scale: 0-10)
[Time Frame: Groups undergoing ART: Change from baseline measures before stimulation during ART to ten days after aspiration. Reference group not undergoing ART: Change from baseline measures to four weeks later.]
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|