Endometrial Injury for Unexplained Infertility
Condition: Infertility
MeSH terms: Infertility
Study type: Interventional

Summary: 
      One hundred and twenty women with unexplained infertility were included in the study. Divided
      randomly into two groups:

      Group I: (60 patients): (control group)

      Group II (60 patients): (study group)

      All the patients received (CC) and human menopausal gonadotropin. On day 5 of the cycle,
      Doppler examination was performed to all patients. Also on day 5, but only for group (II)
      patients, local endometrial injury was performed. Doppler studies was repeated, for all our
      patients, on the same day of prescribing human chorionic gonadotropin
    

Detailed description: 
      This randomized case-control study was performed at the Obstetrics and Gynecology Department
      of University Hospital, during the period between October 2013 till July 2015. One hundred
      and twenty women with unexplained infertility were included in the study.

      Written, informed, consent, was taken from all women after explaining the nature and the aim
      of the study. The 120 patients were divided randomly into two groups (based on each alternate
      week referral to the clinic). All the patients received Clomiphene citrate (CC) and, Human
      menopausal gonadotrophin, according to the following protocol: Clomiphene Citrate (Clomiphene
      tablets, Clomiphene citrate 50 mg), 100 mg/day for 5 consecutive days, with therapy initiated
      on cycle day 3. Human menopausal gonadotrophin (Merional 75 international unit), was injected
      intra-muscularly, in a dose of 150 iu/day, on the days 3, 5, 7, 9 of the menstrual cycle.
      Serial transvaginal ultra sound was performed for all patients starting from day 10 and
      repeated every other day. Human menopausal gonadotrophin was continued daily, in the same
      dose, until follicles reached 18-22 mm. When the dominant follicles reached 18-22 mm, as
      measured by transvaginal ultrasound, human chorionic gonadotropin (5000 international unit)
      was injected intramuscularly, in a dose of 5,000 - 10,000 IU, and timed intercourse was
      advised, 36 h after human chorionic gonadotropin injection and the days after. Vaginal
      ultrasound was done about 60 h after human chorionic gonadotropin injection to confirm
      follicular rupture. On day 5 of the cycle, Doppler examination was performed to all patients.
      Also on day 5, but only for group II patients, local endometrial injury was performed.
      Doppler studies was repeated, for all our patients, on the same day of prescribing human
      chorionic gonadotropin.

      Technique of trans vaginal ultrasound: Trans vaginal sonography examination was performed
      with patient in the lithotomy position using transvaginal transducer with color Doppler
      facility, a longitudinal view of the uterus was obtained then, the color Doppler mode was
      activated. The endometrial and subendometrial blood flow distribution pattern was determined
      by demonstrating pulsatile color signals in the sub endometrial and endometrial regions.
      Doppler sonography was performed on the vessels with the highest color intensity within the
      innermost endometrial and sub endometrial area. The insonation angle was kept at 0° to
      identify the course of the small spiral arteries. After confirming that waveforms were
      continuous, an average of three to five cardiac cycles were selected for calculation of
      resistance index (RI), pulsatility index (PI). The vessel with the lowest PI was considered
      for further statistical analysis. Uterine circulation was assessed simultaneously in each
      examination; bilateral uterine arteries were sampled lateral to the cervix near the internal
      os. Mean levels of both uterine RI and PI were used for analysis.on the day of human
      chorionic gonadotropin administration the endometrial thickness was measured, and reported.
      on the same day The endometrial pattern was evaluated and described as a multilayered or a
      non-multilayered endometrium. A trilaminar endometrium presented as a triple-line pattern in
      which hyperechogenic outer lines and a well-defined central echogenic line with hypoechogenic
      or black areas between these lines. A non trilaminar endometrium consisted of homogeneous
      endometrial patterns, characterized by either hyperechogenic or isoechoic endometrium.

      Technique of endometrial injury: Endometrial injury was done only for patient of the study
      group. It was done on day 5, under complete aseptic conditions, no anesthesia, was given in
      most of cases. Endometrial local injury was performed on the posterior wall, midline, and
      10-15 mm from the fundus using pipelle endometrial sampling (Pipelle).
    

Intervention name(s): endometrial injury
Intervention type(s): Device
Intervention description(s): Endometrial injury was done only for patient of the study group. It was done on day 5, under complete aseptic conditions, no anesthesia, was given in most of cases. Endometrial local injury was performed on the posterior wall, midline, and 10-15 mm from the fundus using pipelle endometrial sampling (Pipelle).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: unexplained infertility; endometrial injury; pregnancy