Artificial Reproductive Techniques (ART) and Progression of Endometriosis Symptoms
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|ClinicalTrials.gov Identifier: NCT02762461|
Recruitment Status : Completed
First Posted : May 5, 2016
Last Update Posted : April 6, 2018
|Condition or disease||Intervention/treatment|
|Endometriosis||Procedure: IVF or ICSI|
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 [Patient Registry]|
|Actual Enrollment :||154 participants|
|Target Follow-Up Duration:||4 Weeks|
|Official Title:||Artificial Reproductive Techniques (ART) and Progression of Endometriosis Symptoms|
|Actual Study Start Date :||February 2016|
|Actual Primary Completion Date :||April 2018|
|Actual Study Completion Date :||April 2018|
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.
- 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).
- 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02762461
|Department of Gynaecology and Obstetrics, Aarhus University Hospital|
|Aarhus, Denmark, 8000|
|Principal Investigator:||Mie Mathiasen, Student||University of Aarhus|