Researchers conducted this study to assess insertion-linked pain and the short-term user-acceptability and safety of the GyneFix® compared with T-framed IUDs.

The study design used was a randomized controlled trial in an outpatient clinic setting.

A total of 175 women received an IUD in the long-term arm. The short-term arm was discontinued due to low recruitment, and therefore, the results relate to the long-term component only. The outcome was known in 98% of subjects. The actual insertion procedure was scored as more painful for the GyneFix, both by the women and the doctors making their assessment of the women’s pain. The women with GyneFix described less pain in the subsequent 30 days after insertion. 

The study concluded that although the actual fitting may be more painful, pain is less during the six weeks after insertion of GyneFix. Fewer women discontinue its use because of pain, as compared with Gyne-T380S. The high overall continuation rate of all emergency IUDs at six weeks and low morbidity was seen in this study favors more frequent IUD insertion where unprotected intercourse has also occurred, given its higher efficacy over oral hormonal EC.