Endometrial injury
ProcedureOffice hysteroscopy (Karl Storz, Tuttlingen, Germany)
NCT Number: NCT02628756
Women between 18-39 years old who had been infertile (primary or secondary) for at least 1 year were recruited. In a parallel assignment eligible participants were randomized to receive either a single, site-specific endometrial injury guided by hysteroscopy (Study group) or no intervention (Control group). Natural cycle folliculometry + timed sexual intercourse were offered for all participants for the ongoing and the immediate 2 concecutive cycles. Clinical pregnancy rates were the primary outcome and miscarriage rates were the secondary outcome measures.
Looking for future studies?
Notify Me18 year–40 year
Female
Interventional
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Office hysteroscopy (Karl Storz, Tuttlingen, Germany)
Time frame: Three consecutive months
Time frame: Three consecutive months
Mansoura Integrated Fertility Center
Other
Endometrial Injury Does Not Improve Pregnancy Rates in Women With Unexplained Infertility
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT07398924
Anovulatory Infertility, Female Infertility
Van, Di̇yarbakir, Turkey (Türkiye)
View Trial DetailsNCT03401918
Recurrent Pregnancy Loss, Unexplained Infertility
Sunnyvale, California, United States
View Trial DetailsNCT03828786
Genital Diseases, Infertility
Montreal, Quebec, Canada
View Trial DetailsNCT06178523
Unexplained Infertility
Jeddah, Mecca Region, Saudi Arabia
View Trial Details