NCT03166657

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
56

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 24, 2017

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 25, 2017

Completed
9 months until next milestone

Study Start

First participant enrolled

March 1, 2018

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2019

Completed
Last Updated

May 12, 2020

Status Verified

May 1, 2020

Enrollment Period

1.3 years

First QC Date

May 24, 2017

Last Update Submit

May 10, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • percentage of patients with abnormal scar findings in hysteroscopy

    color of the scar and presence of niche

    1 year

Interventions

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

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodProbability 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

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Women Health Hospital

Asyut, 71511, Egypt

Location

Related 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. doi: 10.1093/humrep/dem046. Epub 2007 Mar 21.

    PMID: 17376819BACKGROUND
  • 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. doi: 10.1016/0020-7292(92)90257-j.

    PMID: 1361459BACKGROUND

MeSH Terms

Conditions

Infertility, Female

Condition Hierarchy (Ancestors)

Genital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesInfertility

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal investigator

Study Record Dates

First Submitted

May 24, 2017

First Posted

May 25, 2017

Study Start

March 1, 2018

Primary Completion

June 1, 2019

Study Completion

June 1, 2019

Last Updated

May 12, 2020

Record last verified: 2020-05

Data Sharing

IPD Sharing
Will not share

Locations