Unexplained pregnancy loss remains a major reproductive challenge, and effective management strategies for affected couples are limited. Although intrauterine insemination (IUI) is widely used in reproductive medicine, its effectiveness in improving subsequent pregnancy outcomes among couples with unexplained pregnancy loss has not been well established. This multicenter, open-label, randomized controlled trial aims to evaluate whether IUI improves subsequent pregnancy outcomes compared with natural conception in couples with unexplained pregnancy loss. A total of 558 eligible couples will be enrolled and randomly assigned to either an IUI group or a natural conception group. Participants will be followed to assess reproductive outcomes. The findings of this study are expected to provide high-quality evidence regarding the role of IUI in the management of unexplained pregnancy loss and to inform future clinical practice.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
558
Participants assigned to the intervention group undergo intrauterine insemination (IUI) according to the study protocol. Processed sperm is placed into the uterine cavity during the periovulatory period to improve the likelihood of conception.
Beijing Amcare Beisanhuan Women's & Children's Hospital
Beijing, Beijing Municipality, China
NOT_YET_RECRUITINGLanzhou university second hosipital
Lanzhou, Gansu, China
RECRUITINGHebei Reproductive Health Hospital
Shijiazhuang, Hebei, China
NOT_YET_RECRUITINGEarly Miscarriage Rate
The proportion of women who experience pregnancy loss before 10 weeks of gestation among those achieving pregnancy.
Time frame: From randomization until 10 weeks of gestation
Clinical Pregnancy Rate
Clinical pregnancy confirmed by ultrasonographic visualization of an intrauterine gestational sac.
Time frame: From randomization until clinical pregnancy assessment (6-8 weeks of gestation)
Live Birth Rate
Delivery of a live infant after 24 weeks of gestation.
Time frame: From randomization until delivery (approximately 40 weeks of gestation)
Preterm Birth Rate
Delivery occurring between 28 and 37 completed weeks of gestation.
Time frame: From randomization until delivery (approximately 40 weeks of gestation)
Adverse Event Rate
Occurrence of adverse events including ovarian hyperstimulation syndrome, infection, and other treatment-related complications.
Time frame: From enrollment until completion of study follow-up (approximately 40 weeks of gestation)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.