Office Hysteroscopy in Secondary Infertility After Cesarean Section

Infertility, Female Clinical Trial

Official title:

Role of Office Hysteroscopy in Cases of Secondary Infertility After Cesarean Section

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03166657
• Other study ID #: OHCS
• Status: Completed
• Start date: March 1, 2018
• Est. completion date: June 1, 2019

Study information

• Verified date: May 2020
• Source: Assiut University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

All women with history of secondary infertility after caesarean section will be subjected to office hysteroscopy according to Royal college of obstetrics and gynecology guidelines to diagnose any subtle uterine abnormalities not detected by conventional means.

Hysteroscopic examination will be done during the proliferation phase of the menstrual cycle.

The hysteroscopic evaluation will include assessment of the cervical canal, intrauterine lesions, the endometrium and the uterotubal junction. .

If hysteroscopy reveal a lesion, its type, size, location will be recorded. Transvaginal ultrasound will be done after the procedure to detect fluid in the douglas pouch to confirm patent tubes.

Asses the uterine scar in details.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: June 1, 2019
• Est. primary completion date: June 1, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

• Patients with secondary infertility more than 2 years after cesarean section.

• Normal semen analysis

• Normal hysterosalpingography or laparoscopy within 1year

• Evidence of ovulation by transvaginal ultrasound

Exclusion Criteria:

• • Cases with abnormal semen parameters.

• Patients with abnormal hysterosalpingography.

• Patients with anovulation.

• Hormonal disturbances; high level of prolactin, thyroid hormone disturbances, very high or very low follicular stimulating hormone and luteinizing hormone

• Patients known to be epileptic or with history of fits.

• Cardiac patients ( valve diseases, ischemic, arrhythmic)

Related Conditions & MeSH terms

• Infertility
• Infertility, Female

Intervention

Procedure:
• office hysteroscopy
A speculum is first inserted into the vagina. The hysteroscope is then inserted and gently moved through the cervix into uterus. Carbon dioxide gas or a fluid, such as saline will be put through the hysteroscope into uterus to expand it. The gas or fluid helps see the lining more clearly. The amount of fluid used is carefully checked throughout the procedure

Locations

Country	Name	City	State
Egypt	Women Health Hospital	Assiut

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

References & Publications (2)

Boivin J, Bunting L, Collins JA, Nygren KG. International estimates of infertility prevalence and treatment-seeking: potential need and demand for infertility medical care. Hum Reprod. 2007 Jun;22(6):1506-12. Epub 2007 Mar 21. Erratum in: Hum Reprod. 2007 Oct;22(10):2800. — View Citation

Collins JA, Crosignani PG. Unexplained infertility: a review of diagnosis, prognosis, treatment efficacy and management. Int J Gynaecol Obstet. 1992 Dec;39(4):267-75. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	percentage of patients with abnormal scar findings in hysteroscopy	color of the scar and presence of niche	1 year