Fertility in Untreated Rectosigmoid Endometriosis

November 16, 2020 updated by: Fabio Barra, Ospedale Policlinico San Martino

Fertility in Patients With Untreated Rectosigmoid Endometriosis

Several studies investigated the reproductive outcomes after surgical treatment of colorectal endometriosis, mainly segmental colorectal resection. Little information is available on the spontaneous fertility of patients with bowel endometriosis. This study aims to evaluate the fertility of patients affected by rectosigmoid endometriosis who did not undergo previous surgical treatment.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

215

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Genoa, Italy, 16132
        • IRCCS Ospedale Policlinico San Martino

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Patients with rectosigmoid endometriosis not undergoing surgical treatment

Description

Inclusion Criteria:

  • Desire of conception
  • Diagnosis of rectosigmoid endometriosis by transvaginal ultrasonography (TVS) and magnetic resonance imaging enema (MR-e)

Exclusion Criteria:

  • Previous surgery for endometriosis
  • Diagnosis of hydrosalpinx at imaging
  • Previous conception
  • Abnormal semen parameters of male partners

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients with rectosigmoid endometriosis
Behavioral: Expectant management
Patients did not undergo surgical treatment for endometriosis and medical consultations were done every 6 months from the beginning of the attempts to conceive

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical pregnancy rate
Time Frame: 4-9 weeks after conception
Ultrasonographic evidence of intrauterine gestational sac
4-9 weeks after conception
Live birth rate
Time Frame: 22 weeks after conception
Complete expulsion or extraction from a woman of a product of fertilization after 22 completed weeks of gestational age, which, after such separation, breathes or shows any other evidence of life
22 weeks after conception

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number (%) of patients conceiving spontaneously/by Assisted Reproductive Technology
Time Frame: Immediately after diagnosis of clinical pregnancy
Modality of conception
Immediately after diagnosis of clinical pregnancy
Number (%) of patients undergoing vaginal delivery/delivering by cesarean section
Time Frame: 22-42 weeks after conception
Modality of delivery
22-42 weeks after conception

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ospedale Policlinico San Martino

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2009

Primary Completion (Actual)

January 1, 2020

Study Completion (Actual)

January 1, 2020

Study Registration Dates

First Submitted

April 5, 2020

First Submitted That Met QC Criteria

April 5, 2020

First Posted (Actual)

April 8, 2020

Study Record Updates

Last Update Posted (Actual)

November 18, 2020

Last Update Submitted That Met QC Criteria

November 16, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FERT-RECTOSIGM-ENDO

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Endometriosis

Clinical Trials on Expectant management

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Uganda

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe