Unexplained Pregnancy Loss
Conditions
Brief summary
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.
Interventions
PROCEDUREIntrauterine Insemination (IUI)
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.
Sponsors
Lanzhou University Second Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
20 Years to 37 Years
Healthy volunteers
No
Inclusion criteria
* Female participants aged 20-37 years. * History of at least one ultrasound-confirmed pregnancy loss (excluding biochemical pregnancy, ectopic pregnancy, and hydatidiform mole), with the most recent pregnancy loss occurring within the previous 12 months. * Desire for pregnancy at the time of enrollment. * Basal follicle-stimulating hormone (FSH) \<10 IU/L. * Anti-Müllerian hormone (AMH) \>1.1 ng/mL. * Male partner's semen analysis meeting the criteria for intrauterine insemination (IUI), with a post-processing total progressive motile sperm count ≥5 × 10⁶. * Ability and willingness to provide written informed consent.
Exclusion criteria
* Congenital or acquired uterine structural abnormalities. * Thyroid dysfunction, defined as thyroid-stimulating hormone (TSH) \>4.0 mIU/L. * Positive antiphospholipid antibodies, including lupus anticoagulant, anticardiolipin antibodies, or anti-β2 glycoprotein I antibodies. * Parental chromosomal abnormalities or a history of fetal chromosomal abnormalities in a previous pregnancy. * Participation in another interventional clinical trial during the study period.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Early Miscarriage Rate | From randomization until 10 weeks of gestation | The proportion of women who experience pregnancy loss before 10 weeks of gestation among those achieving pregnancy. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinical Pregnancy Rate | From randomization until clinical pregnancy assessment (6-8 weeks of gestation) | Clinical pregnancy confirmed by ultrasonographic visualization of an intrauterine gestational sac. |
| Live Birth Rate | From randomization until delivery (approximately 40 weeks of gestation) | Delivery of a live infant after 24 weeks of gestation. |
| Preterm Birth Rate | From randomization until delivery (approximately 40 weeks of gestation) | Delivery occurring between 28 and 37 completed weeks of gestation. |
| Adverse Event Rate | From enrollment until completion of study follow-up (approximately 40 weeks of gestation) | Occurrence of adverse events including ovarian hyperstimulation syndrome, infection, and other treatment-related complications. |
Countries
China
Contacts
CONTACTFang Wang, PhD
Outcome results
None listed