Table 2.
Methodological data of the clinical trials included in the review
| Criterion | Author, year (reference) | ||||
|---|---|---|---|---|---|
| Agha-Hosseini, 2012 [18] | Maher, 2011 [19] | Kyrou, 2010 [20] | Ebrahimi, 2010 [21] | Erdem, 2009 [22] | |
| Explicit eligibility criteria | Yes | Yes | Yes | Yes | Yes |
| Sequence generation | Yes (computer-generated random allocation) | Yes (computer-generated random allocation in each patient for the first cycle and subsequently alternated from then onward) | Yes (computer-generated random allocation) | No (patients were sequentially allocated in each patient for the first cycle, remaining in the same intervention group from then onward) | Yes (computer-generated random allocation in each patient for the first cycle, remaining in the same intervention group from then onward) |
| Allocation concealed | Yes (nurses gave treatment according to allocation charts derived from randomized sequence) | Not described | No (the computer generated list was not concealed to investigators) | No (a nurse sequentially allocated patients) | Yes (an investigator held the random sequence, and two additional investigators performed the insemination procedure) |
| Patient blinding | Open trial | Open trial | Open trial | Open trial | Open trial |
| Outcome assessor blinding | Not described | Not described | Not described | Open trial | Not described |
| Patients lost to follow-up (%) | No patient lost to follow-up. Drop outs: 10 out of 300 patients (3.3 %): 5 patients (2 in the progesterone group, 3 cycles in the control group) did not start the IUI cycle, and 5 additional patients in the control group were non-responders. |
No patient lost to follow-up. Drop outs: - 1 out of 71 patients (1.43 %) after the fourth cycle because an IVF cycle was requested. - 25 of the 283 cycles initiated were abandoned (19 due to hyperstimulation, and 6 due to poor response). |
No patient lost to follow-up. Drop outs: 68 out of 468 patients (14,53 %): - 4 patients left due to personal reasons after randomization - 12 patients (7 in the progesterone group and 5 in the control group) did not start the IUI cycle due to abnormal steroid levels. - 52 patients (38 in the progesterone group, 14 in the control group) after stimulation abandoned due to poor response. |
No patient lost to follow-up. Drop outs: 21 out of 200 patients (10.5 %, 11 in the progesterone group, 10 in the control group) dropped out after the 2nd cycle due to unspecified reasons. |
No patient lost to follow-up. Drop outs: 65 out of 214 patients (30.4 %, 30 in the progesterone group, 35 in the control group): - 21 abandoned because an IVF cycle was requested - 5 cycles were cancelled due to hyperstimulation. |
| Risk of bias | Low risk of bias | Low risk of bias | High risk of bias (due to an incorrect allocation concealment) | High risk of bias (due to an incorrect randomisation) | Low risk of bias |