NCT02636400

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).

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2014

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

March 23, 2015

Completed
9 months until next milestone

First Posted

Study publicly available on registry

December 21, 2015

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2017

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 26, 2018

Completed
Last Updated

July 3, 2024

Status Verified

July 1, 2024

Enrollment Period

3.3 years

First QC Date

March 23, 2015

Last Update Submit

July 2, 2024

Conditions

EndometriosisInfertility

Keywords

Infertilityendometriosis

Outcome Measures

Primary Outcomes (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

Study Arms (2)

expectant

NO INTERVENTION

7 menstrual cycles of expectant management

postop IUI

EXPERIMENTAL

4 IUI cycles within 7 menstrual cycles

Other: controlled ovarian stimulation with gonadotropins + intrauterine insemination

Interventions

controlled ovarian stimulation with gonadotropins + intrauterine inseminationOTHER
Also known as: postop IUI
postop IUI

Eligibility Criteria

Age18 Years - 37 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • frozen (donor or partner) sperm
  • clinical and/or imaging evidence of endometriosis recurrence/persistence at randomization
  • FSH \> 20 IU/L

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UZ Leuven

Leuven, 3000, Belgium

Location

MeSH Terms

Conditions

EndometriosisInfertility

Interventions

Gonadotropins

Condition Hierarchy (Ancestors)

Genital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Intervention Hierarchy (Ancestors)

Peptide HormonesHormonesHormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

  • Thomas D'Hooghe, MD, PhD

    UZ Leuven

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 23, 2015

First Posted

December 21, 2015

Study Start

February 1, 2014

Primary Completion

June 1, 2017

Study Completion

January 26, 2018

Last Updated

July 3, 2024

Record last verified: 2024-07

Locations

BE(1)