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

NCT ID: NCT02636400

Last Updated: 2024-07-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-02-28

Study Completion Date

2018-01-26

Brief Summary

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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).

Detailed Description

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Conditions

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Endometriosis Infertility

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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expectant

7 menstrual cycles of expectant management

Group Type NO_INTERVENTION

No interventions assigned to this group

postop IUI

4 IUI cycles within 7 menstrual cycles

Group Type EXPERIMENTAL

controlled ovarian stimulation with gonadotropins + intrauterine insemination

Intervention Type OTHER

Interventions

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controlled ovarian stimulation with gonadotropins + intrauterine insemination

Intervention Type OTHER

Other Intervention Names

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postop IUI

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

37 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Universitaire Ziekenhuizen KU Leuven

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Thomas D'Hooghe, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

UZ Leuven

Locations

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UZ Leuven

Leuven, , Belgium

Site Status

Countries

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Belgium

Other Identifiers

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S55983

Identifier Type: -

Identifier Source: org_study_id

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