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OpenTrials
Completed

NCT Number: NCT04338035

Fertility in 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.

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Key information

Conditions

Endometriosis Bowel Endometriosis Endometriosis Colon Endometriosis, Rectum Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Urogenital Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

IRCCS Ospedale Policlinico San Martino

Genoa, 16132, Italy

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Expectant management

Behavioral

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

Primary outcomes

  1. Clinical pregnancy rate

    Time frame: 4-9 weeks after conception

    Ultrasonographic evidence of intrauterine gestational sac

  2. 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

Secondary outcomes

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

    Time frame: Immediately after diagnosis of clinical pregnancy

    Modality of conception

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

    Time frame: 22-42 weeks after conception

    Modality of delivery

Sponsors and collaborators

Lead sponsor

Ospedale Policlinico San Martino

Other

Registry information

Official study title

Fertility in Patients With Untreated Rectosigmoid Endometriosis

Important dates

Study start
2009
Primary completion
2020
Study completion
2020
First posted
Apr 8, 2020
Registry last updated
Nov 18, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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