Artificial Reproductive Techniques (ART) and Progression of Endometriosis Symptoms

April 5, 2018 updated by: University of Aarhus
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

154

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Aarhus, Denmark, 8000
        • Department of Gynaecology and Obstetrics, Aarhus University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 40 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Women with endometriosis under the age of 40 years.

Description

Inclusion Criteria:

  • Female
  • < 40 years
  • Either undergoing ART (IVF or ICSI) with or without endometriosis or medically treated endometriosis

Exclusion Criteria:

  • > 40 years

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Exposed group
Women with peritoneal/ovarian endometriosis and DIE (rectovaginal and rectosigmoid endometriosis) undergoing ART (IVF or ICSI).
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).
Procedure: IVF or ICSI
Reference group 2
Women with medically treated endometriosis not undergoing ART.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
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 Measures

Outcome Measure
Measure Description
Time Frame
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.
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.
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.
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.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Aarhus

Investigators

  • Principal Investigator: Mie Mathiasen, Student, University of Aarhus

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2016

Primary Completion (Actual)

April 1, 2018

Study Completion (Actual)

April 1, 2018

Study Registration Dates

First Submitted

April 28, 2016

First Submitted That Met QC Criteria

May 2, 2016

First Posted (Estimate)

May 5, 2016

Study Record Updates

Last Update Posted (Actual)

April 6, 2018

Last Update Submitted That Met QC Criteria

April 5, 2018

Last Verified

April 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MMF2016

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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