Impact of Operation on Fertility for Women with Severe Endometriosis (EFFORT)

Horsens Hospital

Status: Enrolling

Conditions: Deep Endometriosis; Infertility, Female

Treatments: Procedure: Operation; Procedure: Fertility treatment

Study type: Interventional

Funder types: Other

Identifiers

NCT04610710

Horsens MR

Details and patient eligibility

About

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.

Enrollment: 352 estimated patients

Sex: Female

Ages: 18 to 38 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• Endometriosis involving the ureter unilaterally or bilaterally (randomization unethical)
• BMI above 32
• Contraindication for IVF (untreated uterine factor infertility, untreated/maltreated systemic or malignant disease, oocyte aspiration severely riskful (e.g. severe abdominal adhesions)
• No wish for randomization

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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352 participants in 2 patient groups

Operation

Active Comparator group

Description:

Operation for severe endometriosis

Treatment:

Procedure: Operation

Fertility treatment

Active Comparator group

Description:

Fertility treatment for women with severe endometriosis.

Treatment:

Procedure: Fertility treatment