Office Hysteroscopy in Secondary Infertility After Cesarean Section

• Sponsor: Assiut University (Other)
• Overall Status: Completed
• CT.gov ID: NCT03166657
• Collaborator: (none)
• Enrollment: 56
• Location: 1
• Actual Duration (Months): 15
• Patients Per Site Per Month: 3.7

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Infertility, Female	Procedure: office hysteroscopy

Study Design

• Study Type: Observational
• Actual Enrollment: 56 participants
• Observational Model: Case-Only
• Time Perspective: Cross-Sectional
• Official Title: Role of Office Hysteroscopy in Cases of Secondary Infertility After Cesarean Section
• Actual Study Start Date: Mar 1, 2018
• Actual Primary Completion Date: Jun 1, 2019
• Actual Study Completion Date: Jun 1, 2019

Outcome Measures

Primary Outcome Measures

1. percentage of patients with abnormal scar findings in hysteroscopy [1 year]

   color of the scar and presence of niche

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 45 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Women Health Hospital	Assiut		Egypt	71511

Sponsors and Collaborators

• Assiut University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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.
• 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.

• Responsible Party: Ayman Ahmad Abdelraof Ahmad Askar, principal investigator, Assiut University
• ClinicalTrials.gov Identifier: NCT03166657
• Other Study ID Numbers: OHCS
• First Posted: May 25, 2017
• Last Update Posted: May 12, 2020
• Last Verified: May 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Infertility; Infertility, Female

Study Results

No Results Posted as of May 12, 2020