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

Primary Purpose

Endometriosis, Infertility

Status

Unknown status

Phase

Not Applicable

Locations

Belgium

Study Type

Interventional

Intervention

controlled ovarian stimulation with gonadotropins + intrauterine insemination

About this trial

This is an interventional treatment trial for Endometriosis focused on measuring Infertility, endometriosis

Eligibility Criteria

18 Years - 37 Years (Adult)FemaleDoes not accept 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

Sites / Locations

UZ Leuven

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

expectant

postop IUI

Arm Description

7 menstrual cycles of expectant management

4 IUI cycles within 7 menstrual cycles

Outcomes

Primary Outcome Measures

cumulative clinical pregnancy rate

Secondary Outcome Measures

Full Information

NCT ID

NCT02636400

First Posted

March 23, 2015

Last Updated

October 25, 2017

Sponsor

Universitaire Ziekenhuizen KU Leuven

1. Study Identification

Unique Protocol Identification Number

NCT02636400

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2017

Overall Recruitment Status

Unknown status

Study Start Date

February 2014 (undefined)

Primary Completion Date

June 2017 (Actual)

Study Completion Date

December 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Universitaire Ziekenhuizen KU Leuven

4. Oversight

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Endometriosis, Infertility

Keywords

Infertility, endometriosis

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

24 (Actual)

8. Arms, Groups, and Interventions

Arm Title

expectant

Arm Type

No Intervention

Arm Description

7 menstrual cycles of expectant management

Arm Title

postop IUI

Arm Type

Experimental

Arm Description

4 IUI cycles within 7 menstrual cycles

Intervention Type

Other

Intervention Name(s)

controlled ovarian stimulation with gonadotropins + intrauterine insemination

Other Intervention Name(s)

postop IUI

Primary Outcome Measure Information:

Title

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

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

37 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Thomas D'Hooghe, MD, PhD

Organizational Affiliation

UZ Leuven

Official's Role

Principal Investigator

Facility Information:

Facility Name

UZ Leuven

City

Leuven

ZIP/Postal Code

3000

Country

Belgium

12. IPD Sharing Statement

Learn more about this trial

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

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