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
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)|
|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|
Subjected to bath diagnostic hystroscopy and laparoscopy
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
- tubal pathology [ Time Frame: 6 months after hsterosalpingogram ]tubal patency tested through transcervical dye injection during laparoscopy
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03106012
|Contact: Ahmed Maged, MDfirstname.lastname@example.org|
|Kasr Alainy medical school||Recruiting|
|Cairo, Egypt, 12151|
|Contact: Ahmed Maged, MD 01005227404 email@example.com|
|Principal Investigator:||Ahmed Maged, MD||Kasr Alainy medical school|