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CompletedNCT03354780Updated Nov 28, 2017

Endometriosis and Risk of Miscarriage

An observational study in Endometriosis and Miscarriage, sponsored by Endometriosis Treatment Italian Club. Completed. Open to female participants aged 30 Years to 50 Years. Per ClinicalTrials.gov, last updated 2017-11-28.

Sponsored by Endometriosis Treatment Italian Club · Observational

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Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
844
Ages
30 Years to 50 Years
Sex
Female
01

Study summary

The aim of this study is to compare the rate of miscarriage at first spontaneous pregnancy among women with endometriosis with the rate of miscarriage at first spontaneous pregnancy among women without endometriosis.

Read the detailed description

All women followed up for a surgical or sonographic diagnosis of endometriosis in 11 italian referral Centres for the treatment of endometriosis completed a questionnaire regarding their previous pregnancies. The same questionnaire was completed by women, attending a routine gynecologic visit, in whom surgery or vaginal examination and pelvic ultrasonography excluded endometriosis.

02

Conditions studied

  • Endometriosis
  • Miscarriage
03

In context

Endometriosis

921 studies on the registry are indexed under Endometriosis; 267 are open to participants now.

This study's enrollment of 844 is above the median of 135 across 349 observational studies indexed under Endometriosis.

Browse Endometriosis studies →

Lead sponsor

Endometriosis Treatment Italian Club is the lead sponsor of 2 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
30 Years to 50 Years
Sexes eligible
Female
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

All continous women attending endometriosis clinics or undergoing a routine gynecological examination matching the inclusion criteria

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 30 to 50 years old women
  • with at least one previous spontaneous pregnancy
  • with surgical or clinical/sonographic diagnosis of endometriosis or
  • in whom surgical or clinical/sonographic evaluation ruled out endometriosis

Exclusion criteria

Exclusion Criteria:

  • Pregnancy achieved by Assisted Reproductive technology
  • Biochemical pregnancy
  • Non corrected uterine malformation, poliabortivity, lupus like anticoagulant
05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
844 participants (actual)
Patient registry
No

Groups and cohorts

  • endometriosis

    Survey on first pregnancy after endometriosis diagnosis

    Other: Survey on first pregnancy after endometriosis diagnosis

  • non endometriosis

    Survey on first pregnancy

    Other: Survey on first pregnancy

Interventions

  • OtherSurvey on first pregnancy after endometriosis diagnosis

    rate of miscarriage was noted

  • OtherSurvey on first pregnancy

    rate of miscarriage was noted

06

What researchers measure

Primary outcomes

  1. Rate of miscarriage

    comparison of rate of miscarriage in the two groups

    Time frame: 2 years

07

Study locations

No study locations are listed for this record.

08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Jan 2016 to primary completion in Oct 2017, 20 months.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 21, 2017
First posted
Nov 28, 2017
StartActual
Jan 15, 2016
Primary completionActual
Oct 4, 2017
CompletionActual
Oct 4, 2017
Last update
Nov 28, 2017
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Nov 28, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03354780
Lead sponsor
Endometriosis Treatment Italian Club
Collaborators
University of Milan
Responsible party
Sponsor
First posted
Nov 28, 2017
Start date
Jan 15, 2016
Primary completion
Oct 4, 2017
Completion
Oct 4, 2017
Last update
Nov 28, 2017

Study contacts

Nicola Berlanda, MD
principal investigator · Endometriosis Treatment Italian Club

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2017. You cannot join it, but the record below documents what was studied.

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Discussion

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