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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02636400
Recruitment Status : Active, not recruiting
First Posted : December 21, 2015
Last Update Posted : October 26, 2017
Sponsor:
Information provided by (Responsible Party):
Universitaire Ziekenhuizen Leuven

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
Endometriosis Infertility Other: controlled ovarian stimulation with gonadotropins + intrauterine insemination Not Applicable

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Study Type : Interventional  (Clinical Trial)
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 : February 2014
Actual Primary Completion Date : June 2017
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine


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 Name: postop IUI




Primary Outcome Measures :
  1. cumulative clinical pregnancy rate [ Time Frame: 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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Ages Eligible for Study:   18 Years to 37 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02636400


Locations
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Belgium
UZ Leuven
Leuven, Belgium, 3000
Sponsors and Collaborators
Universitaire Ziekenhuizen Leuven
Investigators
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Principal Investigator: Thomas D'Hooghe, MD, PhD UZ Leuven

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Responsible Party: Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier: NCT02636400     History of Changes
Other Study ID Numbers: S55983
First Posted: December 21, 2015    Key Record Dates
Last Update Posted: October 26, 2017
Last Verified: May 2017

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Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Universitaire Ziekenhuizen Leuven:
Infertility
endometriosis

Additional relevant MeSH terms:
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Infertility
Endometriosis
Genital Diseases, Male
Genital Diseases, Female