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Office Hysteroscopy in Secondary Infertility After Cesarean Section

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ClinicalTrials.gov Identifier: NCT03166657
Recruitment Status : Not yet recruiting
First Posted : May 25, 2017
Last Update Posted : May 25, 2017
Sponsor:
Information provided by (Responsible Party):
Ayman Ahmad Abdelraof Ahmad Askar, Assiut University

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
Infertility, Female Procedure: office hysteroscopy

Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Role of Office Hysteroscopy in Cases of Secondary Infertility After Cesarean Section
Estimated Study Start Date : July 1, 2017
Estimated Primary Completion Date : January 1, 2019
Estimated Study Completion Date : March 1, 2019

Resource links provided by the National Library of Medicine



Intervention Details:
  • 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


Primary Outcome Measures :
  1. percentage of patients with abnormal scar findings in hysteroscopy [ Time Frame: 1 year ]
    color of the scar and presence of niche



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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
This study will include all secondary infertile cases after cesarean section who presented to infertility clinic at Women health Hospital, Assiut University
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03166657


Contacts
Contact: hazem saad eldin, professor 01001028150 hazemsaad20012@yahoo.com
Contact: ahmed abdelalim, lecturer 01001085865 aboaliabdelaleem@gmail.com

Sponsors and Collaborators
Assiut University

Publications:
Responsible Party: Ayman Ahmad Abdelraof Ahmad Askar, principal investigator, Assiut University
ClinicalTrials.gov Identifier: NCT03166657     History of Changes
Other Study ID Numbers: OHCS
First Posted: May 25, 2017    Key Record Dates
Last Update Posted: May 25, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
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
Genital Diseases, Male
Genital Diseases, Female