Comparing Impact of Operation and Fertility Treatment on Fertility for Women with Deep Infiltrating Endometriosis: a Multicenter Randomized Controlled Trial
Status: Recruiting
Location: See all (3) locations...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
The EFFORT study compares the impact on fertility of operation or fertility treatment (IVF, in vitro fertilization) in a multicenter randomized controlled trial. The study population consists of women with colorectal deep infiltrating endometriosis and a pregnancy intention. These women will be randomized to either of the two treatment groups: Group A = Operation or Group B = fertility treatment (IVF). Group A will be further divided postoperatively into spontaneous conception or IVF depending on the Endometriosis Fertility Index score.
Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 38
Healthy Volunteers: f
View:
• Rectosigmoid endometriosis and wish for surgery
• Pregnancy intention for at least 6 months
• AMH above 5 pmol/ml
• Maximum of 2 previous IVF treatments
• Male partner
Locations
Other Locations
Denmark
Aarhus University Hospital
RECRUITING
Aarhus N
Horsens Regional Hospital
RECRUITING
Horsens
France
The Endometriosis Center, Clinique Tivoli-Ducos
RECRUITING
Bordeaux
Contact Information
Primary
Ulla B Knudsen, Professor
ubk@dadlnet.dk
+45 78426592
Backup
Maja Raos
majaraos@clin.au.dk
Time Frame
Start Date: 2020-08-01
Estimated Completion Date: 2035-07-31
Participants
Target number of participants: 352
Treatments
Active_comparator: Operation
Operation for severe endometriosis
Active_comparator: Fertility treatment
Fertility treatment for women with severe endometriosis.
Related Therapeutic Areas
Sponsors
Leads: Horsens Hospital
Collaborators: Clinique Tivoli Ducos, Aarhus University Hospital