Endometrial Injury in Women With Unexplained Infertility
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|ClinicalTrials.gov Identifier: NCT02628756|
Recruitment Status : Completed
First Posted : December 11, 2015
Last Update Posted : December 14, 2015
|Condition or disease||Intervention/treatment||Phase|
|Unexplained Infertility||Procedure: Endometrial injury||Not Applicable|
A single site-specific hysteroscopic injury procedure (Snip) will be performed using an office hysteroscopy (Karl Storz, Germany). By means of vaginoscopy, a 2.9 mm. continuous-flow diagnostic hysteroscope with a 5 Fr. working-channel is guided through the cervical canal with normal saline as distension medium, with flow manually regulated through the key of the hysteroscopic sheath.
The examination of the uterine cavity begins by observing its regularity, paying special attention to the presence of intrauterine malformations or morphologic alterations such as submucous myomas, or uterine septa. Subsequently, A claw forceps will be introduced through a 2.2 mm working channel, and will be used to generate a local injury on the upper posterior endometrium (Endometrial Snip) at midline 10-15 mm from the fundus on D4 to D7 of the ongoing menstrual cycle. The depth and width of the injured site will be about 2x2 mm (i.e a single bite of the claw forceps). No premedications, antibiotics or hemostatics will be given after the procedure.
Natural cycle folliculometry + timed sexual intercourse will be offered for all participants for the ongoing and the immediate subsequent cycles. Once the leading ovarian follicle will reach a size of at least 16 mm, 10,000 IU of hCG will be administered to trigger ovulation.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||120 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Endometrial Injury Does Not Improve Pregnancy Rates in Women With Unexplained Infertility|
|Study Start Date :||June 2013|
|Actual Primary Completion Date :||July 2015|
|Actual Study Completion Date :||July 2015|
Experimental: Endometrial injury
Hysteroscopic-guided endometrial injury (Karl Storz, Tuttlingen, Germany).
Procedure: Endometrial injury
Office hysteroscopy (Karl Storz, Tuttlingen, Germany)
- Clinical pregnancy rates (PR) [ Time Frame: Three consecutive months ]
- Miscarriage rates [ Time Frame: Three consecutive months ]
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): NCT02628756
|Principal Investigator:||Tarek Shokeir, M.D.||Mansoura University Hospital, Mansoura Faculty of Medicine|