Artificial Reproductive Techniques (ART) and Progression of Endometriosis Symptoms

Endometriosis Clinical Trial

Official title:

Artificial Reproductive Techniques (ART) and Progression of Endometriosis Symptoms

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02762461
• Other study ID #: MMF2016
• Status: Completed
• First received: April 28, 2016
• Last updated: April 5, 2018
• Start date: February 2016
• Est. completion date: April 2018

Study information

• Verified date: April 2018
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 154
• Est. completion date: April 2018
• Est. primary completion date: April 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A to 40 Years

Eligibility

Inclusion Criteria:

• Female

• < 40 years

• Either undergoing ART (IVF or ICSI) with or without endometriosis or medically treated endometriosis

Exclusion Criteria:

• > 40 years

Related Conditions & MeSH terms

• Endometriosis

Intervention

Procedure:
• IVF or ICSI

Locations

Country	Name	City	State
Denmark	Department of Gynaecology and Obstetrics, Aarhus University Hospital	Aarhus

Sponsors (1)

Lead Sponsor	Collaborator
University of Aarhus

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	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	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.	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	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.	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.