Intracavitary Fluid and Position of C-section-scar

Fluid Uterus Clinical Trial

Official title:

Does the Presence of Intracavitary Fluid During Hormonal Stimulation for IVF Depends on the Position of C-section-scar?

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03518385
• Other study ID #: 1802-ABU-018-HF
• Status: Completed
• Start date: June 12, 2018
• Est. completion date: July 17, 2019

Study information

• Verified date: August 2019
• Source: IVI Middle East Fertility Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 104
• Est. completion date: July 17, 2019
• Est. primary completion date: March 13, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Fluid Uterus

Intervention

Diagnostic Test:
• ultrasound,transvaginal scan
The presence of fluid in the uterine cavity during hormonal stimulation.

Locations

Country	Name	City	State
United Arab Emirates	IVI Middle East Fertility Clinic	Abu Dhabi

Sponsors (1)

Lead Sponsor	Collaborator
IVI Middle East Fertility Clinic

Country where clinical trial is conducted

United Arab Emirates, 

References & Publications (4)

Bij de Vaate AJ, Brölmann 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. — View Citation

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. — View Citation

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. Review. — View Citation

Vervoort AJ, Uittenbogaard LB, Hehenkamp WJ, Brölmann 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	1 year and 6 months
Secondary	Thickness of fluid accumulation in the cavity	Presence or Absence of ICF	1 year and 6 months

External Links

•   Rise in number of C-section deliveries.