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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
Sponsor:
Information provided by (Responsible Party):
University of Aarhus

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.

Condition or disease Intervention/treatment
Endometriosis Procedure: IVF or ICSI

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.


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Study Type : Observational [Patient Registry]
Actual Enrollment : 154 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endometriosis

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.



Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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.

  2. 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.



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Ages Eligible for Study:   up to 40 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Women with endometriosis under the age of 40 years.
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • > 40 years

Information from the National Library of Medicine

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


Locations
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Denmark
Department of Gynaecology and Obstetrics, Aarhus University Hospital
Aarhus, Denmark, 8000
Sponsors and Collaborators
University of Aarhus
Investigators
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Principal Investigator: Mie Mathiasen, Student University of Aarhus

Additional Information:

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Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT02762461     History of Changes
Other Study ID Numbers: MMF2016
First Posted: May 5, 2016    Key Record Dates
Last Update Posted: April 6, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by University of Aarhus:
Fertilization in Vitro
Sperm Injections, Intracytoplasmic
Endometriosis
Additional relevant MeSH terms:
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Endometriosis
Genital Diseases, Female