Immediate Intra Uterine Isemination (IUI) Versus Expectant Management in Postoperative Endometriosis Patients

Universitaire Ziekenhuizen KU Leuven

Status: Terminated

Conditions: Infertility; Endometriosis

Treatments: Other: controlled ovarian stimulation with gonadotropins + intrauterine insemination

Study type: Interventional

Funder types: Other

Identifiers

NCT02636400

S55983

Details and patient eligibility

About

Is postoperative IUI better than expectant management in infertile endometriosis patients with good prognosis based on their EFI score? (A single centre randomised controlled trial).

Enrollment: 24 patients

Sex: Female

Ages: 18 to 37 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• recent (<6months) complete laparoscopic endometriosis resection
• endometriosis fertility index (EFI) at least 7/10
• Regular menstrual cycles (min 24days - max 38days) with proven ovulation
• At least one functional tube at surgery, normal uterus
• Sperm sample of partner: normal or mild male factor

Exclusion criteria

• frozen (donor or partner) sperm
• clinical and/or imaging evidence of endometriosis recurrence/persistence at randomization
• FSH > 20 IU/L

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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24 participants in 2 patient groups

expectant

No Intervention group

Description:

7 menstrual cycles of expectant management

postop IUI

Experimental group

Description:

4 IUI cycles within 7 menstrual cycles

Treatment:

Other: controlled ovarian stimulation with gonadotropins + intrauterine insemination