Hysteroscopic-guided Endometrial Injury in Women With Unexplained Infertility

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.

2013-08-07

2015-01-07

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.

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.

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.

Clusters

Yes

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.

Around 100 patients

50 patients for each group.

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.