ClinicalTrials.gov
ClinicalTrials.gov Menu

The Role of Hysterolaparoscopy in Infertile Patients With Normal Hysterosalpingography

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03106012
Recruitment Status : Recruiting
First Posted : April 10, 2017
Last Update Posted : April 10, 2017
Sponsor:
Information provided by (Responsible Party):
Ahmed Maged, Cairo University

Brief Summary:

The hysteroscopy used was rigid continuous flow diagnostic hysteroscopy (Tuttligen, Karl Storz, Germany). It has a 30o panoramic optic which is 4mm in diameter and the diagnostic continuous flow outer sheath is 6.5 mm in diameter.

The patient was placed in lithotomy position with the buttocks projecting slightly beyond the table edge. A reflex camera (Olympus) with an objective that has a focal length varies from f70 to f140 together with (Karl Storz) special zoom length, adapter to Hopkins telescope and a suitable cableware used with computer flash unit. The hysteroscopic picture which appeared through the optic, transmitted on the monitor by the camera which is fitted on the eyepiece of the optic where the panoramic diagnostic hysteroscopy could be informed with better visualization and accuracy. The light generator which is a metal halide automatic light source with a 150 watt lamp (model G71A,Circon ACMI, Germany) was switched on and the high cable was attached to the hysteroscope. Dilatation of the cervix was avoided whenever possible to avoid leakage of the medium into the vagina. The hysteroscope was then introduced into the external os and advanced under vision along the axis of cervical canal.

Once the cavity was entered, an overview of the uterine cavity was performed. This was followed by systematic examination for fundus then tubal ostia on both sides then the uterine wall through slow rotatory movements of the telescope.

Diagnostic laparoscopy was done in the proliferative phase of the menstrual cycle .The patients were placed in the dorsal lithotomy position to allow vaginal access for uterine manipulation; the legs positioned so that the thighs are slightly flexed no more than 90o from the plane of the abdomen.

The patient was placed in the complete horizontal position, Veress needle was placed through the umbilicus and into the peritoneal cavity, the primary trocar with sleeve (5mm in diameter) was placed at a similar angle in to the Veress needle.

Secondary trocars were used, 2 secondary trocars were placed. The trocars were placed laterally, approximately 8 cm from the midline and 8 cm above the pubic symphysis to avoid the epigastric, vessels which are 5.5 cm from the midline at this level.

Then laparoscopic dye chromotubation was performed


Condition or disease Intervention/treatment Phase
Infertility, Female Procedure: Hysteroscopy Procedure: Laparoscopy Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: The Value of Diagnostic Hysterolaparoscopy in Infertile Patients With Normal Hysterosalpingography
Actual Study Start Date : March 31, 2017
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Hsyterolaparoscopy
Subjected to bath diagnostic hystroscopy and laparoscopy
Procedure: Hysteroscopy
rigid continuous flow diagnostic hysteroscopy (Tuttligen, Karl Storz, Germany). It has a 30o panoramic optic which is 4mm in diameter and the diagnostic continuous flow outer sheath is 6.5 mm in diameter.

Procedure: Laparoscopy
Veress needle was placed through the umbilicus and into the peritoneal cavity,After a pneumo-peritoneum has been achieved with a Veress needle, the primary trocar with sleeve (5mm in diameter) was placed at a similar angle in to the Veress needle




Primary Outcome Measures :
  1. tubal pathology [ Time Frame: 6 months after hsterosalpingogram ]
    tubal patency tested through transcervical dye injection during laparoscopy



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   21 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Primary infertility defined as failure to conceive after one year of unprotected sexual intercourse
  2. No detectable pelvic pathology based on history, physical examination and trans-vaginal ultrasound
  3. Previous received treatment of six or more cycles in the form of ovulation stimulation
  4. Normal HSG

Exclusion Criteria:

  1. Couples with male factor infertility
  2. Sexual problems
  3. Contraindications to laparoscopy

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): NCT03106012


Contacts
Contact: Ahmed Maged, MD 01005227404 prof.ahmedmaged@gmail.com

Locations
Egypt
Kasr Alainy medical school Recruiting
Cairo, Egypt, 12151
Contact: Ahmed Maged, MD    01005227404    prof.ahmedmaged@gmail.com   
Sponsors and Collaborators
Cairo University
Investigators
Principal Investigator: Ahmed Maged, MD Kasr Alainy medical school

Responsible Party: Ahmed Maged, Assistant professor, Cairo University
ClinicalTrials.gov Identifier: NCT03106012     History of Changes
Other Study ID Numbers: 163
First Posted: April 10, 2017    Key Record Dates
Last Update Posted: April 10, 2017
Last Verified: April 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