Artificial Reproductive Techniques (ART) and Progression of Endometriosis Symptoms

NCT02762461 | Completed

• 1 other identifier: MMF2016
• Study Type: observational
• Target: 154
• Locations: 1 country
• Sites: 1

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.

Conditions

Endometriosis

Keywords

Fertilization in Vitro; Sperm Injections, Intracytoplasmic; Endometriosis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 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.

• 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.

Study Arms (3)

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.

Interventions

IVF or ICSI PROCEDURE

Exposed group; Reference group 1

Eligibility Criteria

• Age: Up to 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Women with endometriosis under the age of 40 years.

You may qualify if:

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

You may not qualify if:

• \> 40 years

Sponsors & Collaborators

• University of Aarhus: lead

Study Sites (1)

Department of Gynaecology and Obstetrics, Aarhus University Hospital

Aarhus, 8000, Denmark

Location

MeSH Terms

Conditions

Endometriosis

Interventions

Sperm Injections, Intracytoplasmic

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Fertilization in Vitro; Reproductive Techniques, Assisted; Reproductive Techniques; Therapeutics; Investigative Techniques

Study Officials

• Mie Mathiasen, Student

  University of Aarhus

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 4 Weeks
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 28, 2016
• First Posted: May 5, 2016
• Study Start: February 1, 2016
• Primary Completion: April 1, 2018
• Study Completion: April 1, 2018
• Last Updated: April 6, 2018

Record last verified: 2018-04

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)