Intracavitary Fluid and Position of C-section-scar

NCT ID: NCT03518385

Last Updated: 2019-08-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

104 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-06-12

Study Completion Date

2019-07-17

Brief Summary

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Does the presence of intracavitary fluid during hormonal stimulation for IVF depends on the position of C-section-scar ?

Detailed Description

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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

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Fluid Uterus

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

ultrasound,transvaginal scan

Intervention Type DIAGNOSTIC_TEST

The presence of fluid in the uterine cavity during hormonal stimulation.

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.

ultrasound,transvaginal scan

Intervention Type DIAGNOSTIC_TEST

The presence of fluid in the uterine cavity during hormonal stimulation.

Interventions

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ultrasound,transvaginal scan

The presence of fluid in the uterine cavity during hormonal stimulation.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* Patients above an age of 18 years.
* Patients performing IVF treatment.
* One or multiple C-sections.
* C-scar region visible during trans-vaginal scan.

Exclusion Criteria

* Patients who were IUD carriers in the last 3 months.
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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ART Fertility Clinics LLC

OTHER

Sponsor Role lead

Responsible Party

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Barbara Lawrenz

Scientific Director

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Human Fatemi, MD

Role: PRINCIPAL_INVESTIGATOR

ART Fertility Clinics LLC

Locations

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IVI Middle East Fertility Clinic

Abu Dhabi, , United Arab Emirates

Site Status

Countries

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United Arab Emirates

References

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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.

Reference Type BACKGROUND
PMID: 21031351 (View on PubMed)

Tower 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.

Reference Type BACKGROUND
PMID: 23680518 (View on PubMed)

Vervoort 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.

Reference Type BACKGROUND
PMID: 26409016 (View on PubMed)

Chien 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.

Reference Type BACKGROUND
PMID: 11821277 (View on PubMed)

Lawrenz 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.

Reference Type DERIVED
PMID: 31885047 (View on PubMed)

Related Links

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Other Identifiers

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1802-ABU-018-HF

Identifier Type: -

Identifier Source: org_study_id

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