Hysteroscopic-guided Endometrial Injury in Women With Unexplained Infertility
Last registered on October 22, 2014

Pre-Trial

Trial Information
General Information
Title
Hysteroscopic-guided Endometrial Injury in Women With Unexplained Infertility
RCT ID
AEARCTR-0000532
Initial registration date
October 22, 2014
Last updated
October 22, 2014 7:14 AM EDT
Location(s)
Region
Primary Investigator
Affiliation
Other Primary Investigator(s)
Additional Trial Information
Status
On going
Start date
2013-08-07
End date
2015-03-31
Secondary IDs
Abstract
Since an impairment of endometrial receptivity may be a potential cause of subfertility in women diagnosed with unexplained infertility (UI), therefore, it is supposed that local endometrial injury may help a group of women with UI. Based on this concept, the aim of this trial is to evaluate the efficacy of local endometrial injury (site-specific hysteroscopic-guided) in a group of women with UI undergoing expectant management versus no intervention.
External Link(s)
Registration Citation
Citation
Shokeir, Tarek. 2014. "Hysteroscopic-guided Endometrial Injury in Women With Unexplained Infertility ." AEA RCT Registry. October 22. https://www.socialscienceregistry.org/trials/532/history/2964
Experimental Details
Interventions
Intervention(s)
Study population:-
In a prospective randomized open-labeled study, this trial will be conducted at the Department of Obstetrics & Gynecology, Mansoura University Hospital. The study will be approved by the Ethics Committee of Mansoura University On Human Investigations, and all subjects will give written informed consent.
One hundred women between 18-39 years old who had been infertile (primary or secondary) for at least 1 year will be recruited. A complete evaluation will be conducted on all patients including history & physical examination. Semen analysis for all male partners will be done and WHO criteria will be used to confirm normality. Tubal patency will be confirmed by hysterosalpingography (HSG) and/or laparoscopy. All patients recruited for the study will have regular ovulatory cycles confirmed by mid-luteal serum progesterone assay and diagnosis of UI will be confirmed in all cases. A standard transvaginal sonography (TVS) will be done for all participants to rule out any pelvic pathology.
In addition to abnormal semen analysis and HSG, exclusion criteria will include female age over 40 years, presence of uterine fibroids, pelvic endometriosis, basal FSH of >11 mIU/ml, hypo-or hyperthyroidism, hyperprolactinemia, previous exposure to any ovulation induction agents in the previous 3 months before the trial, and women who refuse to participate in this trial or not aiming to complete the follow-up.

Study protocol:
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 anterior or 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.
Intervention Start Date
2013-08-07
Intervention End Date
2015-01-07
Primary Outcomes
Primary Outcomes (end points)

Our cases will be followed-up prospectively. Anterior and posterior uterine wall snips will be compared. The primary outcome will be the clinical crude pregnancy rate (PR) per woman on the ongoing and the immediate subsequent cycles. Clinical pregnancy is defined as visualization of fetal cardiac pulsations on TVS, 2-3 weeks following a +ve pregnancy test. Secondary outcome will be the miscarriage rate.
Primary Outcomes (explanation)
Secondary Outcomes
Secondary Outcomes (end points)
Secondary Outcomes (explanation)
Experimental Design
Experimental Design
In a prospective randomized open-labeled study, this trial will be conducted at the Department of Obstetrics & Gynecology, Mansoura University Hospital. The study will be approved by the Ethics Committee of Mansoura University On Human Investigations, and all subjects will give written informed consent.
One hundred women between 18-39 years old who had been infertile (primary or secondary) for at least 1 year will be recruited. A complete evaluation will be conducted on all patients including history & physical examination. Semen analysis for all male partners will be done and WHO criteria will be used to confirm normality. Tubal patency will be confirmed by hysterosalpingography (HSG) and/or laparoscopy. All patients recruited for the study will have regular ovulatory cycles confirmed by mid-luteal serum progesterone assay and diagnosis of UI will be confirmed in all cases. A standard transvaginal sonography (TVS) will be done for all participants to rule out any pelvic pathology.
In addition to abnormal semen analysis and HSG, exclusion criteria will include female age over 40 years, presence of uterine fibroids, pelvic endometriosis, basal FSH of >11 mIU/ml, hypo-or hyperthyroidism, hyperprolactinemia, previous exposure to any ovulation induction agents in the previous 3 months before the trial, and women who refuse to participate in this trial or not aiming to complete the follow-up.
Study protocol:
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 anterior or 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.
Experimental Design Details
Randomization Method
Eligible patients will be randomized in office by a closed envelopes.The selection of women to whom a site-directed endometrial injury will be done will be determined by the patient's identification number. Women with odd identification numbers will be chosen for active intervention study group, and patients with even identification numbers will be chosen for no intervention control group.

The study will be open-labeled and single-blinded. Patients' allocation will be done through a nurse picking-up a sealed opaque consecutively numbered envelopes.
Randomization Unit
Clusters
Was the treatment clustered?
Yes
Experiment Characteristics
Sample size: planned number of clusters
Sample size will be calculated using Epi Info® version 6.0, setting the type- I error (α) at 0.05 and the power (1- β) at 0.8, data from previous studies. According to these values and at 95% confidence interval, a minimal sample size of 40 patients was accepted to reach statistically accepted figure. Therefore, a total number of 50 patients for each group will be recruited in this study.
Sample size: planned number of observations
Around 100 patients
Sample size (or number of clusters) by treatment arms
50 patients for each group.
Minimum detectable effect size for main outcomes (accounting for sample design and clustering)
Sample size will be calculated using Epi Info® version 6.0, setting the type- I error (α) at 0.05 and the power (1- β) at 0.8, data from previous studies. According to these values and at 95% confidence interval, a minimal sample size of 40 patients was accepted to reach statistically accepted figure. Therefore, a total number of 50 patients for each group will be recruited in this study.
IRB
INSTITUTIONAL REVIEW BOARDS (IRBs)
IRB Name
Egypt: Institutional Review Board (Mansoura University Medical Research Committee)
IRB Approval Date
2013-10-03
IRB Approval Number
529
Post-Trial
Post Trial Information
Study Withdrawal
Intervention
Is the intervention completed?
No
Is data collection complete?
Data Publication
Data Publication
Is public data available?
No
Program Files
Program Files
Reports and Papers
Preliminary Reports
Relevant Papers