NCT04338035

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
215

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2009

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

May 1, 2009

Completed
10.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2020

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

April 5, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 8, 2020

Completed
Last Updated

November 18, 2020

Status Verified

November 1, 2020

Enrollment Period

10.7 years

First QC Date

April 5, 2020

Last Update Submit

November 16, 2020

Conditions

Outcome Measures

Primary Outcomes (2)

  • Clinical pregnancy rate

    Ultrasonographic evidence of intrauterine gestational sac

    4-9 weeks after conception

  • Live birth rate

    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 Outcomes (2)

  • Number (%) of patients conceiving spontaneously/by Assisted Reproductive Technology

    Immediately after diagnosis of clinical pregnancy

  • Number (%) of patients undergoing vaginal delivery/delivering by cesarean section

    22-42 weeks after conception

Study Arms (1)

Patients with rectosigmoid endometriosis

Behavioral: Expectant management

Interventions

Patients did not undergo surgical treatment for endometriosis and medical consultations were done every 6 months from the beginning of the attempts to conceive

Patients with rectosigmoid endometriosis

Eligibility Criteria

Age18 Years+
Sexfemale
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with rectosigmoid endometriosis not undergoing surgical treatment

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

IRCCS Ospedale Policlinico San Martino

Genoa, 16132, Italy

Location

Related Publications (1)

  • Remorgida V, Ferrero S, Fulcheri E, Ragni N, Martin DC. Bowel endometriosis: presentation, diagnosis, and treatment. Obstet Gynecol Surv. 2007 Jul;62(7):461-70. doi: 10.1097/01.ogx.0000268688.55653.5c.

    PMID: 17572918BACKGROUND

MeSH Terms

Conditions

Endometriosis

Interventions

Watchful Waiting

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Outcome Assessment, Health CareOutcome and Process Assessment, Health CareQuality of Health CareHealth Services Administration

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 5, 2020

First Posted

April 8, 2020

Study Start

May 1, 2009

Primary Completion

January 1, 2020

Study Completion

January 1, 2020

Last Updated

November 18, 2020

Record last verified: 2020-11

Locations