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NCT02636400 Clinical Trial

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

Infertility Clinical Trial

Official title:
Is Postoperative IUI Better Than Expectant Management in Infertile Endometriosis Patients With Good Prognosis Based on EFI Score?

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT02636400
Other study ID # S55983
Secondary ID
Status Active, not recruiting
Phase N/A
First received March 23, 2015
Last updated October 25, 2017
Start date February 2014
Est. completion date December 2018

Study information
Verified date May 2017
Source Universitaire Ziekenhuizen Leuven
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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).

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 24
Est. completion date December 2018
Est. primary completion date June 2017
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 37 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• controlled ovarian stimulation with gonadotropins + intrauterine insemination

Locations
Country Name City State
Belgium UZ Leuven Leuven

Sponsors (1)
Lead Sponsor Collaborator
Universitaire Ziekenhuizen Leuven

Country where clinical trial is conducted

Belgium, 

Outcome
Type Measure Description Time frame Safety issue
Primary cumulative clinical pregnancy rate participants will be followed for the duration of 7 menstrual cycles and in case of pregnancy, they will be followed until the pregnancy outcome is known, implying an average time frame of 1.5 year
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