F S Rep. 2025 Jun 11;6(3):374-380. doi: 10.1016/j.xfre.2025.06.001. eCollection 2025 Sep.

ABSTRACT

OBJECTIVE: To study the impact of 6 months of expectant management (EM) compared with 6 months of intrauterine insemination with ovarian stimulation (IUI-OS) on the health-related quality of life (HRQoL), anxiety and depression scores and the coital frequency in couples with unexplained subfertility and a poor prognosis for natural conception.

DESIGN: A study alongside the ExIUI trial, a multicentre randomized controlled trial.

SUBJECTS: Couples with unexplained subfertility and a poor prognosis for natural conception based on the score of Hunault.

INTERVENTION: Women in both groups were asked to fill in the Fertility Quality of Life (FertiQol) and Hospital Anxiety and Depression Scale (HADS) questionnaires at 3 moments and to keep a diary with their periods and dates of coitus.

MAIN OUTCOME MEASURES: Health-related quality of life scores, anxiety and depression scores, and coital frequency.

RESULTS: Of the 178 women, 161 (90%) filled in at least one questionnaire. Women allocated to EM scored significantly lower on the relational domain compared with women allocated to IUI-OS (overall mean difference, -5.93; 95% confidence interval [CI], -10.64 to -1.22). We found no difference between the two groups in the social domain (overall mean difference, -4.72; 95% CI, -9.88 to 0.45). No difference between the two was found in anxiety (overall mean difference, -0.20; 95% CI, -1.44 to 1.04) or depression scores (overall mean difference, 0.22; 95%CI, -0.86 to 1.30). Among all women allocated to either EM or IUI-OS, anxiety and depression scores increased over time. Seventy-nine (44%) out of 178 women filled in at least one month of their diary and reported on a total of 497 cycles and registered 2,026 dates of coitus. The median coital frequency per cycle was 4 (interquartile range [IQR]: 1-7) in the EM group and 3 (IQR: 0-7) in the IUI-OS group. The median coital frequency in the fertile window per cycle was 2 (IQR: 0-3) in EM and 1 (IQR: 0-3) in IUI-OS, which was a statistically significant difference.

CONCLUSION: Compared with IUI-OS, 6 months of EM resulted in a lower HRQoL on the relational domain, comparable anxiety and depression scores and higher coital frequency in the fertile window.

CLINICAL TRIAL REGISTRATION NUMBER: Dutch Trial register NL5455 (NTR5599).

PMID:41054722 | PMC:PMC12496428 | DOI:10.1016/j.xfre.2025.06.001