Artificial Reproductive Techniques (ART) and Progression of Endometriosis Symptoms
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Endometriosis
- Sponsor
- University of Aarhus
- Enrollment
- 154
- Locations
- 1
- Primary Endpoint
- Endometriosis Health Profile 30® (EHP-30®)
- Status
- Completed
- Last Updated
- 8 years ago
Overview
Brief 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. 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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •\< 40 years
- •Either undergoing ART (IVF or ICSI) with or without endometriosis or medically treated endometriosis
Exclusion Criteria
- •\> 40 years
Outcomes
Primary Outcomes
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).
Secondary Outcomes
- Bowel habits(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)(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.)