Moramezi 2012.
Methods | Parallel‐group randomised controlled trial Single centre, Fertility, Infertility and Perinatology Research Center, School of Medicine, Ahvaz Jundishapour University of Medical Sciences, Ahvaz, Iran Protocol approved by EC/ IRB: yes Study protocol registration: not reported Statistical power calculation: not reported Funding: supported by a research grant from the Ahvaz Jundishapour University of Medical Sciences, Ahvaz, Iran Conflicts of interest reported: no |
Participants | Number recruited: not reported
Number randomly assigned: 110
women
Number excluded: 0 women
110 healthy women, between the
ages of 22 and 44 years, candidate IUI cycles, were randomly assigned to one
of two groups from the start of the cycle. Patient assessment included demographic information, as well as medical and gynaecological history taking, with physical examination and routine laboratory screening (including BMI, CBC, PAP smear, TSH, PRL, and viral serology). Comment: uncertain if all women were screened by transvaginal ultrasound before entering the trial. We could not obtain clarification from the primary study authors. Inclusion criteria: • healthy women Exclusion criteria: • sexually transmitted disease • pelvic inflammatory disease • pregnancy • active vaginal bleeding Study duration: 10 months. |
Interventions |
Hysteroscopy (intervention: N = 55) vs no hysteroscopy
(control: N = 55) before IUI.
The women of group 1 (intervention, N =
55) underwent hysteroscopy to rule out pathology of the endometrial cavity.
During this procedure, the endometrial cavity was examined for the presence
of polyps, or submucosal myoma, or other pathologic conditions. Any
projection inside the uterine cavity was observed, with special attention to
its shape and echo, whether it was of polypoid‐like structure, or type of
myomas. No data on the instrumentation used, the timing and technique of the
hysteroscopic intervention, or the type of anaesthesia. In case of surgical treatment of unsuspected uterine cavity abnormalities, IUI was started after 2 or 3 cycles, whereas IUI was done in the next cycle when hysteroscopy was normal. The women of group 2 (control, N = 55) were treated with IUI without prior hysteroscopy. Clomifen (50 to 100 mg per day) followed by HMG (75 U per day) were given for ovarian stimulation. Transvaginal ultrasonography was done between cycle day 12 and 14. A single dose of human chorionic gonadotrophin (hCG) was used to induce ovulation if the follicles were about 18 to 20 mm. Semen specimens were washed using the swim‐up method, and a single IUI using a volume of 0.3 mL was done 36 hours after hCG injection. Pregnancy was documented by the serum hCG level, 2 weeks after IUI. When pregnant, a transvaginal ultrasound examination was carried out 2 to 4 weeks later. |
Outcomes | No explicit prioritisation of outcomes by the primary study authors. Main outcome: pregnancy rate. Pregnancy was not defined. In the abstract, the authors mention clinical pregnancy rates. According to the methods section, pregnancy was documented by a serum hCG level, 2 weeks after IUI. When positive, a transvaginal examination was scheduled 2 to 4 weeks later. We assume that only clinical pregnancies, defined by positive findings at transvaginal ultrasound after positive hCG testing, were counted as the main outcome measure. The time point at which the main outcome was measured (clinical pregnancy) was not reported. We judged that the clinical pregnancy rates were measured after one IUI cycle, since the number of women treated was 110 and the number of IUI cycles was 114,±,2.07 in the control group and 106,±,1.92 in the intervention group. Other outcomes: abortion rate ‐ not defined, and hysteroscopy complications. |
Notes | Did not report if participants had already had a hysteroscopy prior to the fertility assessment or not. No information on endometrial biopsy or not at the time of the screening hysteroscopy. We repeatedly contacted the corresponding author (Dr Masoud Hemadi) but failed to obtain further clarification. |
hCG =