Fertility in Untreated Rectosigmoid Endometriosis

Completed

• Conditions: Bowel Endometriosis; Endometriosis Colon; Endometriosis, Rectum; Endometriosis
• Interventions: Behavioral: Expectant management

• Registration Number: NCT04338035
• Lead Sponsor: Ospedale Policlinico San Martino

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-05-01
• Primary Completion: 2020-01-01
• Study Completion: 2020-01-01
• Study First Submitted: 2020-04-05
• Study First Submitted QC: 2020-04-05
• Study First Posted: 2020-04-08
• Status Verified: 2020-11
• Last Update Submitted: 2020-11-16
• Last Update Posted: 2020-11-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 215

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with rectosigmoid endometriosis	Expectant management	-

Primary Outcome Measures

Name	Time	Method
Clinical pregnancy rate	4-9 weeks after conception	Ultrasonographic evidence of intrauterine gestational sac
Live birth rate	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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

IRCCS Ospedale Policlinico San Martino; 🇮🇹 Genoa, Italy