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NCT04338035 Clinical Trial

Fertility in Untreated Rectosigmoid Endometriosis

Endometriosis Clinical Trial

Official title:
Fertility in Patients With Untreated Rectosigmoid Endometriosis

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04338035
Other study ID # FERT-RECTOSIGM-ENDO
Secondary ID
Status Completed
Phase
First received
Last updated
Start date May 1, 2009
Est. completion date January 1, 2020

Study information
Verified date November 2020
Source Ospedale Policlinico San Martino
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 215
Est. completion date January 1, 2020
Est. primary completion date January 1, 2020
Accepts healthy volunteers
Gender Female
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
Italy IRCCS Ospedale Policlinico San Martino Genoa

Sponsors (1)
Lead Sponsor Collaborator
Ospedale Policlinico San Martino

Country where clinical trial is conducted

Italy, 

References & 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. Review. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Clinical pregnancy rate Ultrasonographic evidence of intrauterine gestational sac 4-9 weeks after conception
Primary 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 Number (%) of patients conceiving spontaneously/by Assisted Reproductive Technology Modality of conception Immediately after diagnosis of clinical pregnancy
Secondary Number (%) of patients undergoing vaginal delivery/delivering by cesarean section Modality of delivery 22-42 weeks after conception
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