EndometriosisNCT04338035
Fertility in Untreated Rectosigmoid Endometriosis
An observational study of Endometriosis and Bowel Endometriosis, run by Ospedale Policlinico San Martino at 1 site in Italy.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Endometriosis, Bowel Endometriosis, Endometriosis, Rectum
- What is being tested?
- Expectant management
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 215 participants
- Where
- 1 siteItaly
- Study dates
- 1 May 2009to 1 Jan 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Adult, Older adult
Study population: Patients with rectosigmoid endometriosis not undergoing surgical treatment
Who may be able to join
- Desire of conception
- Diagnosis of rectosigmoid endometriosis by transvaginal ultrasonography (TVS) and magnetic resonance imaging enema (MR-e)
Who cannot join
- Previous surgery for endometriosis
- Diagnosis of hydrosalpinx at imaging
- Previous conception
- Abnormal semen parameters of male partners
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Fertility in Patients With 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.
- Being tested
- Expectant management
- Medical subject headings
- Endometriosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Expectant managementBehavioural
Patients did not undergo surgical treatment for endometriosis and medical consultations were done every 6 months from the beginning of the attempts to conceive
| Study group | Role | What they receive |
|---|---|---|
| Patients with rectosigmoid endometriosis | Not described Receives: Behavioral: Expectant management |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical pregnancy rate
Ultrasonographic evidence of intrauterine gestational sac
Measured: 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
Measured: 22 weeks after conception
Secondary outcomes (2)
Number (%) of patients conceiving spontaneously/by Assisted Reproductive Technology
Modality of conception
Measured: Immediately after diagnosis of clinical pregnancy
Number (%) of patients undergoing vaginal delivery/delivering by cesarean section
Modality of delivery
Measured: 22-42 weeks after conception
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2020
- Study start1 May 2009
- Primary completion1 Jan 2020
- Study completion1 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for EndometriosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 215 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ospedale Policlinico San Martino
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fabio Barra, Ospedale Policlinico San Martino
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04338035
- Sponsor's protocol ID
- FERT-RECTOSIGM-ENDO
- Status last verified
- Nov 2020
- First submitted
- 5 Apr 2020
- Last updated
- 18 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 17572918
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fertility in Patients With Untreated Rectosigmoid Endometriosis
- ClinicalTrials.gov ID
- NCT04338035
- Acronym / sponsor ID
- FERT-RECTOSIGM-ENDO
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 215 participants (actual)
- Lead sponsor
- Ospedale Policlinico San MartinoUniversity, hospital or other
- Study start
- 1 May 2009 (actual)
- Primary completion
- 1 Jan 2020 (actual)
- Study completion
- 1 Jan 2020 (actual)
- First posted
- 8 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with rectosigmoid endometriosis | – | Behavioral: Expectant management |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Age groups
- Adult, Older adult
- Study population
- Patients with rectosigmoid endometriosis not undergoing surgical treatment
Key inclusion criteria (2 listed)
- Desire of conception
- Diagnosis of rectosigmoid endometriosis by transvaginal ultrasonography (TVS) and magnetic resonance imaging enema (MR-e)
Key exclusion criteria (4 listed)
- Previous surgery for endometriosis
- Diagnosis of hydrosalpinx at imaging
- Previous conception
- Abnormal semen parameters of male partners
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Expectant managementPatients did not undergo surgical treatment for endometriosis and medical consultations were done every 6 months from the beginning of the attempts to conceive | Behavioural | Patients with rectosigmoid endometriosis |
Primary outcome
Clinical pregnancy rate
Time frame: 4-9 weeks after conception
Ultrasonographic evidence of intrauterine gestational sac
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
2 secondary outcomes
Number (%) of patients conceiving spontaneously/by Assisted Reproductive Technology
Time frame: Immediately after diagnosis of clinical pregnancy
Number (%) of patients undergoing vaginal delivery/delivering by cesarean section
Time frame: 22-42 weeks after conception
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2020.
- Background: PubMed 17572918Remorgida 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Endometriosis and Bowel Endometriosis, run by Ospedale Policlinico San Martino at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical pregnancy rate (time frame: 4-9 weeks after conception). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04338035, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2020.