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

Sponsor
Universitaire Ziekenhuizen Leuven (Other)
Overall Status
Unknown status
CT.gov ID
NCT02636400
Collaborator
(none)
24
Enrollment
1
Location
2
Arms
58
Duration (Months)
0.4
Patients Per Site Per Month

Study Details

Study Description

Brief 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).

Condition or Disease Intervention/Treatment Phase
  • Other: controlled ovarian stimulation with gonadotropins + intrauterine insemination
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
24 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Is Postoperative IUI Better Than Expectant Management in Infertile Endometriosis Patients With Good Prognosis Based on EFI Score?
Study Start Date :
Feb 1, 2014
Actual Primary Completion Date :
Jun 1, 2017
Anticipated Study Completion Date :
Dec 1, 2018

Arms and Interventions

Arm Intervention/Treatment
No Intervention: expectant

7 menstrual cycles of expectant management
Experimental: postop IUI

4 IUI cycles within 7 menstrual cycles

Other: controlled ovarian stimulation with gonadotropins + intrauterine insemination
Other Names:
  • postop IUI

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 37 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 UZ Leuven Leuven Belgium 3000

    Sponsors and Collaborators

    • Universitaire Ziekenhuizen Leuven

    Investigators

    • Principal Investigator: Thomas D'Hooghe, MD, PhD, UZ Leuven

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Universitaire Ziekenhuizen Leuven
    ClinicalTrials.gov Identifier:
    NCT02636400
    Other Study ID Numbers:
    • S55983
    First Posted:
    Dec 21, 2015
    Last Update Posted:
    Oct 26, 2017
    Last Verified:
    May 1, 2017
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Universitaire Ziekenhuizen Leuven
    Infertility
    endometriosis
    Additional relevant MeSH terms:
    Infertility
    Endometriosis

    Study Results

    No Results Posted as of Oct 26, 2017