Fluid UterusNCT03518385
Intracavitary Fluid and Position of C-section-scar
An observational study of Fluid Uterus, run by ART Fertility Clinics LLC at 1 site in United Arab Emirates.
Trial summary
Does the presence of intracavitary fluid during hormonal stimulation for IVF depends on the position of C-section-scar ? Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Fluid Uterus
- What is being tested?
- ultrasound,transvaginal scan
- How many people
- 104 participants
- Where
- 1 siteUnited Arab Emirates
- Study dates
- 12 Jun 2018to 17 Jul 2019
- 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 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Patients undergoing IVF treatment in the IVI Middle East Clinic Abu Dhabi and Dubai, due to secondary infertility and delivery with at least one previous C-section.
Who may be able to join
- Patients above an age of 18 years.
- Patients performing IVF treatment.
- One or multiple C-sections.
- C-scar region visible during trans-vaginal scan.
Who cannot join
- Patients who were IUD carriers in the last 3 months.
Trial locations and contacts
1 site in 1 country.
United Arab Emirates1 site
IVI Middle East Fertility Clinic
Abu Dhabi, 60202
About this study
Official title: Does the Presence of Intracavitary Fluid During Hormonal Stimulation for IVF Depends on the Position of C-section-scar?
Does the presence of intracavitary fluid during hormonal stimulation for IVF depends on the position of C-section-scar ?
Read the detailed description
To evaluate the correlation between the presence of intracavitary fluid and the position of the C-section-scar in relation to the uterine fundus and the inner cervical os.
To this end, we will compare measured variables, in patients with intracavitary fluid and without intracavitary fluid.
- Conditions
- Fluid Uterus
- Being tested
- ultrasound,transvaginal scan
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ultrasound,transvaginal scanDiagnostic test
The presence of fluid in the uterine cavity during hormonal stimulation.
| Study group | Role | What they receive |
|---|---|---|
| Patients with intracavitary fluid | to evaluate the correlation between the presence of intracavitary fluid during hormonal stimulation for IVF depending on the position of C-section-scar and the presence of an isthmocele, this group patients will have intracavitary fluid. Receives: Diagnostic Test: ultrasound,transvaginal scan | |
| Patients without intracavitary fluid | to evaluate the correlation between the presence of intracavitary fluid during hormonal stimulation for IVF depending on the position of C-section-scar and the presence of an isthmocele, in this group patients will not have intracavitary fluid. Receives: Diagnostic Test: ultrasound,transvaginal scan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence/Absence of ICF
to evaluate the correlation between the presence of intracavitary fluid and the position of the C-section-scar in relation to the inner cervical os, during hormonal stimulation for IVF.
Measured: 1 year and 6 months
Secondary outcomes (1)
Thickness of fluid accumulation in the cavity
Presence or Absence of ICF
Measured: 1 year and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2018
- Study start12 Jun 2018
- Primary completion13 Mar 2019
- Study completion17 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Fluid UterusStudies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- ART Fertility Clinics LLC
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Barbara Lawrenz, ART Fertility Clinics LLC
- Investigators
- Human Fatemi, MD, Principal investigator, ART Fertility Clinics LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03518385
- Sponsor's protocol ID
- 1802-ABU-018-HF
- Status last verified
- Aug 2019
- First submitted
- 25 Apr 2018
- Last updated
- 8 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Bij de Vaate AJ, Brolmann HA, van der Voet LF, van der Slikke JW, Veersema S, Huirne JA. Ultrasound evaluation of the Cesarean scar: relation between a niche and postmenstrual spotting. Ultrasound Obstet Gynecol. 2011 Jan;37(1):93-9. doi: 10.1002/uog.8864.
PubMed 21031351Tower AM, Frishman GN. Cesarean scar defects: an underrecognized cause of abnormal uterine bleeding and other gynecologic complications. J Minim Invasive Gynecol. 2013 Sep-Oct;20(5):562-72. doi: 10.1016/j.jmig.2013.03.008. Epub 2013 May 14.
PubMed 23680518Vervoort AJ, Uittenbogaard LB, Hehenkamp WJ, Brolmann HA, Mol BW, Huirne JA. Why do niches develop in Caesarean uterine scars? Hypotheses on the aetiology of niche development. Hum Reprod. 2015 Dec;30(12):2695-702. doi: 10.1093/humrep/dev240. Epub 2015 Sep 25.
PubMed 26409016Chien LW, Au HK, Xiao J, Tzeng CR. Fluid accumulation within the uterine cavity reduces pregnancy rates in women undergoing IVF. Hum Reprod. 2002 Feb;17(2):351-6. doi: 10.1093/humrep/17.2.351.
PubMed 11821277Lawrenz B, Melado L, Garrido N, Coughlan C, Markova D, Fatemi H. Isthmocele and ovarian stimulation for IVF: considerations for a reproductive medicine specialist. Hum Reprod. 2020 Jan 1;35(1):89-99. doi: 10.1093/humrep/dez241.
PubMed 31885047
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does the Presence of Intracavitary Fluid During Hormonal Stimulation for IVF Depends on the Position of C-section-scar?
- ClinicalTrials.gov ID
- NCT03518385
- Acronym / sponsor ID
- 1802-ABU-018-HF
- Conditions
- Fluid Uterus
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- ART Fertility Clinics LLCUniversity, hospital or other
- Study start
- 12 Jun 2018 (actual)
- Primary completion
- 13 Mar 2019 (actual)
- Study completion
- 17 Jul 2019 (actual)
- First posted
- 8 May 2018 (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.
Does the presence of intracavitary fluid during hormonal stimulation for IVF depends on the position of C-section-scar ?
Detailed description
To evaluate the correlation between the presence of intracavitary fluid and the position of the C-section-scar in relation to the uterine fundus and the inner cervical os.
To this end, we will compare measured variables, in patients with intracavitary fluid and without intracavitary fluid.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with intracavitary fluid | – | Diagnostic Test: ultrasound,transvaginal scanto evaluate the correlation between the presence of intracavitary fluid during hormonal stimulation for IVF depending on the position of C-section-scar and the presence of an isthmocele, this group patients will have intracavitary fluid. |
| Patients without intracavitary fluid | – | Diagnostic Test: ultrasound,transvaginal scanto evaluate the correlation between the presence of intracavitary fluid during hormonal stimulation for IVF depending on the position of C-section-scar and the presence of an isthmocele, in this group patients will not have intracavitary fluid. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Patients undergoing IVF treatment in the IVI Middle East Clinic Abu Dhabi and Dubai, due to secondary infertility and delivery with at least one previous C-section.
Key inclusion criteria (4 listed)
- Patients above an age of 18 years.
- Patients performing IVF treatment.
- One or multiple C-sections.
- C-scar region visible during trans-vaginal scan.
Key exclusion criteria (1 listed)
- Patients who were IUD carriers in the last 3 months.
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 |
|---|---|---|
| ultrasound,transvaginal scanThe presence of fluid in the uterine cavity during hormonal stimulation. | Diagnostic test | Patients with intracavitary fluid, Patients without intracavitary fluid |
Primary outcome
Presence/Absence of ICF
Time frame: 1 year and 6 months
to evaluate the correlation between the presence of intracavitary fluid and the position of the C-section-scar in relation to the inner cervical os, during hormonal stimulation for IVF.
1 secondary outcome
Thickness of fluid accumulation in the cavity
Time frame: 1 year and 6 months
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 8 Aug 2019.
- Background: PubMed 21031351Bij de Vaate AJ, Brolmann HA, van der Voet LF, van der Slikke JW, Veersema S, Huirne JA. Ultrasound evaluation of the Cesarean scar: relation between a niche and postmenstrual spotting. Ultrasound Obstet Gynecol. 2011 Jan;37(1):93-9. doi: 10.1002/uog.8864.
- Background: PubMed 23680518Tower AM, Frishman GN. Cesarean scar defects: an underrecognized cause of abnormal uterine bleeding and other gynecologic complications. J Minim Invasive Gynecol. 2013 Sep-Oct;20(5):562-72. doi: 10.1016/j.jmig.2013.03.008. Epub 2013 May 14.
- Background: PubMed 26409016Vervoort AJ, Uittenbogaard LB, Hehenkamp WJ, Brolmann HA, Mol BW, Huirne JA. Why do niches develop in Caesarean uterine scars? Hypotheses on the aetiology of niche development. Hum Reprod. 2015 Dec;30(12):2695-702. doi: 10.1093/humrep/dev240. Epub 2015 Sep 25.
- Background: PubMed 11821277Chien LW, Au HK, Xiao J, Tzeng CR. Fluid accumulation within the uterine cavity reduces pregnancy rates in women undergoing IVF. Hum Reprod. 2002 Feb;17(2):351-6. doi: 10.1093/humrep/17.2.351.
- Derived from this study: PubMed 31885047Lawrenz B, Melado L, Garrido N, Coughlan C, Markova D, Fatemi H. Isthmocele and ovarian stimulation for IVF: considerations for a reproductive medicine specialist. Hum Reprod. 2020 Jan 1;35(1):89-99. doi: 10.1093/humrep/dez241.
- Rise in number of C-section deliveries.Link provided by the sponsor.
- 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.
Human Fatemi, MD principal investigator
ART Fertility Clinics LLC
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 Fluid Uterus, run by ART Fertility Clinics LLC at 1 site in United Arab Emirates.
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 4 inclusion and 1 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 8 Aug 2019. 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 United Arab Emirates. 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?
Presence/Absence of ICF (time frame: 1 year and 6 months). 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 NCT03518385, which also lists 5 linked publications.
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 8 Aug 2019.