EndometriosisNCT02762461
Artificial Reproductive Techniques (ART) and Progression of Endometriosis Symptoms
An observational study of Endometriosis, run by University of Aarhus at 1 site in Denmark.
Trial summary
This project will investigate worsening of symptoms in endometriosis patients undergoing artificial reproductive techniques (ART). The study compares patients with peritoneal/ovarian and deep infiltrating endometriosis to relevant reference groups. Read more about this study
- Who is it for?
- Ages Up to 40 years, women only
- Conditions the study is for
- Endometriosis
- What is being tested?
- IVF or ICSI
- Type of treatment
- Surgery or procedure
- How many people
- 154 participants
- Where
- 1 siteDenmark
- Study dates
- Feb 2016to Apr 2018
- How long will I take part?
- 4 Weeks
- 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 Up to 40 years
- Women only
- No healthy volunteers
- Child, Adult
Study population: Women with endometriosis under the age of 40 years.
Who may be able to join
- Female
- < 40 years
- Either undergoing ART (IVF or ICSI) with or without endometriosis or medically treated endometriosis
Who cannot join
- > 40 years
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Department of Gynaecology and Obstetrics, Aarhus University Hospital
Aarhus, 8000
About this study
This project will investigate worsening of symptoms in endometriosis patients undergoing artificial reproductive techniques (ART). The study compares patients with peritoneal/ovarian and deep infiltrating endometriosis to relevant reference groups. Symptoms are monitored with a questionnaire with the categories quality of life, pain and bowel habits. The EHP-30® questionnaire is included in the questionnaire.
Read the detailed description
Endometriosis affects up to 10% of all fertile women, and is associated with symptoms like infertility, dysmenorrhea, deep dyspareunia and chronic pelvic pain. 10-25% of endometriosis patients need artificial reproductive techniques (ART) to become pregnant. Endometriosis is estrogen dependent, and in theory this means, that the increased levels of estrogen during fertility treatment will worsen endometriosis symptoms. Endometriosis is a benign disease, and treatment is guided by the patient's symptoms. Worsening of endometriosis symptoms during fertility treatment may result in cessation of the treatment, operation and risk of complications.
This project will investigate worsening of symptoms in endometriosis patients undergoing artificial reproductive techniques (ART). The study compares endometriosis patients undergoing ART to two relevant reference groups; one group consisting women undergoing ART with infertility because of factors other than endometriosis, and one group consisting women with medically treated endometriosis not undergoing ART. Symptoms of endometriosis during ART will be monitored using a questionnaire that among other questions includes the validated questionnaire Endometriosis Health Profile 30® (EHP-30®). The questionnaire is administered before starting ART and later in the cycle before the patient gets to know if she is pregnant. The questionnaires as well as data collection will be administered electronically in REDCap® which is a secure web application for building and managing online surveys and databases.
- Conditions
- Endometriosis
- Being tested
- IVF or ICSI
- Keywords
- Fertilization in Vitro, Sperm Injections, Intracytoplasmic, Endometriosis
- Medical subject headings
- Endometriosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IVF or ICSIProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Exposed group | Women with peritoneal/ovarian endometriosis and DIE (rectovaginal and rectosigmoid endometriosis) undergoing ART (IVF or ICSI). Receives: Procedure: IVF or ICSI | |
| Reference group 1 | Women with infertility because of factors other than endometriosis, e.g. male factor, undergoing ART (IVF or ICSI). Receives: Procedure: IVF or ICSI | |
| Reference group 2 | Women with medically treated endometriosis not undergoing ART. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Endometriosis Health Profile 30® (EHP-30®)
The core instruments have five scale scores covering: Pain (11 questions), control and powerlessness (6 questions), social support (4 questions), emotional well-being (6 questions), self-image (3 questions).
Measured: 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 outcomes (2)
Pain (NRS scale: 0-10)
Three categories with frequency, general, and worst perception of pain. In each category the patient has to rate her pain on the NRS scale according to dysmenorrhea, chronic pelvic pain, dyspareunia, defecation and urination pain. In addition there are qualitative questions in the same categories of pain.
Measured: 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.
Bowel habits
Defecation frequency and time, stool consistency and blood in stool. Frequency and general perception of five bowel symptoms (constipation, diarrhea, nauseousness, emesis, and bloatedness) on a scale from 0-10.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2016 (estimated)
- Study startFeb 2016
- Primary completionApr 2018
- Study completionApr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EndometriosisStudies of the same condition, open and under way.
- More trials run by University of AarhusThe 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
- 154 participants (actual)
- Target duration
- 4 Weeks
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mie Mathiasen, Student, Principal investigator, University of Aarhus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02762461
- Sponsor's protocol ID
- MMF2016
- Status last verified
- Apr 2018
- First submitted
- 28 Apr 2016
- Last updated
- 6 Apr 2018
- 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 6 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Artificial Reproductive Techniques (ART) and Progression of Endometriosis Symptoms
- ClinicalTrials.gov ID
- NCT02762461
- Acronym / sponsor ID
- MMF2016
- Conditions
- Endometriosis
- Keywords
- Fertilization in Vitro, Sperm Injections, Intracytoplasmic, Endometriosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 154 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Study start
- Feb 2016 (actual)
- Primary completion
- Apr 2018 (actual)
- Study completion
- Apr 2018 (actual)
- First posted
- 5 May 2016 (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.
This project will investigate worsening of symptoms in endometriosis patients undergoing artificial reproductive techniques (ART). The study compares patients with peritoneal/ovarian and deep infiltrating endometriosis to relevant reference groups. Symptoms are monitored with a questionnaire with the categories quality of life, pain and bowel habits. The EHP-30® questionnaire is included in the questionnaire.
Detailed description
Endometriosis affects up to 10% of all fertile women, and is associated with symptoms like infertility, dysmenorrhea, deep dyspareunia and chronic pelvic pain. 10-25% of endometriosis patients need artificial reproductive techniques (ART) to become pregnant. Endometriosis is estrogen dependent, and in theory this means, that the increased levels of estrogen during fertility treatment will worsen endometriosis symptoms. Endometriosis is a benign disease, and treatment is guided by the patient's symptoms. Worsening of endometriosis symptoms during fertility treatment may result in cessation of the treatment, operation and risk of complications.
This project will investigate worsening of symptoms in endometriosis patients undergoing artificial reproductive techniques (ART). The study compares endometriosis patients undergoing ART to two relevant reference groups; one group consisting women undergoing ART with infertility because of factors other than endometriosis, and one group consisting women with medically treated endometriosis not undergoing ART. Symptoms of endometriosis during ART will be monitored using a questionnaire that among other questions includes the validated questionnaire Endometriosis Health Profile 30® (EHP-30®). The questionnaire is administered before starting ART and later in the cycle before the patient gets to know if she is pregnant. The questionnaires as well as data collection will be administered electronically in REDCap® which is a secure web application for building and managing online surveys and databases.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 4 Weeks
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Exposed group | – | Procedure: IVF or ICSIWomen with peritoneal/ovarian endometriosis and DIE (rectovaginal and rectosigmoid endometriosis) undergoing ART (IVF or ICSI). |
| Reference group 1 | – | Procedure: IVF or ICSIWomen with infertility because of factors other than endometriosis, e.g. male factor, undergoing ART (IVF or ICSI). |
| Reference group 2 | – | –Women with medically treated endometriosis not undergoing ART. |
Who may qualify
- Ages
- Up to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Women with endometriosis under the age of 40 years.
Key inclusion criteria (3 listed)
- Female
- < 40 years
- Either undergoing ART (IVF or ICSI) with or without endometriosis or medically treated endometriosis
Key exclusion criteria (1 listed)
- > 40 years
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 |
|---|---|---|
| IVF or ICSI | Procedure or surgery | Exposed group, Reference group 1 |
Primary outcome
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.
The core instruments have five scale scores covering: Pain (11 questions), control and powerlessness (6 questions), social support (4 questions), emotional well-being (6 questions), self-image (3 questions).
2 secondary outcomes
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.
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.
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 6 Apr 2018.
- 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.
Mie Mathiasen, Student principal investigator
University of Aarhus
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 Endometriosis, run by University of Aarhus at 1 site in Denmark.
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 3 inclusion and 1 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 6 Apr 2018. 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 Denmark. 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?
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.). 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 6 Apr 2018.