Clinical pregnancy rate of women with unexplained infertility with or without cervical mucus aspiration before intrauterine insemination: A randomized controlled trial

Abstract

Objective: To detect effect of removing cervical mucus before performing intrauterine insemination (IUI) on pregnancy rate in patients with unexplained infertility. Methods: The randomized controlled trial was conducted in Infertility Division of Department of Obstetrics and Gynaecology of a tertiary care hospital. Totally 80 patients of unexplained infertility were recruited. By computer generated block randomization in block size of 4 and 6, patients were randomly allocated at time of starting ovarian stimulation into the cervical mucus removal group or the non-removal of cervical mucus group before IUI, 40 in each group. Ovarian stimulation with clomiphene 100 mg from day 2-6 of menstrual cycle along with human menopausal gonadotropin 150 IU was given alternate day starting from day 7. Follicular monitoring was done and further doses given as per response; trigger was planned when 1-3 follicle reach a diameter of >18 mm. IUI was planned after trigger. IUI was done as per the group allocated. Mucus cleaning was done in the cervical mucus removal group by aspirating mucus with IUI syringe and sterile cotton swab before IUI. The primary outcome was clinical pregnancy rate. Number of difficult IUIs and cycle cancellation due to ovarian hyperstimulation were also noted. Results: IUI was not done in 4 patients due to hyperstimulation. Pregnancies per IUI cycle occurred in 7.9% (3/38) in the cervical mucus removal group and 21.1% (8/38) in the non-removal of cervical mucus group. There was no statistically significant difference in clinical pregnancy rate between two groups (P=0.19). Conclusions: There is a trend towards a lower clinical pregnancy rate with removal of cervical mucus before IUI in women of unexplained infertility though the difference is not statistically significant. Further studies with large sample size need to be done on this intervention. Trial registration: The trial registration was done with Clinical Trial Registry-India (Registration number: CTRI/2019/03/018326).