Fertility in Untreated Rectosigmoid Endometriosis
Fertility in Patients With Untreated Rectosigmoid Endometriosis
1 other identifier
observational
215
1 country
1
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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started May 2009
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2020
CompletedFirst Submitted
Initial submission to the registry
April 5, 2020
CompletedFirst Posted
Study publicly available on registry
April 8, 2020
CompletedNovember 18, 2020
November 1, 2020
10.7 years
April 5, 2020
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
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
Eligibility Criteria
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
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
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
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