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Clinical Trials in China / NCT07759609
Recruiting Not applicable

Effect of Intrauterine Insemination on Subsequent Pregnancy Outcomes in Couples With Unexplained Pregnancy Loss: A Multicenter, Open-label, Randomized Controlled Trial

NCT07759609 · tracked via the Priya Life Science China tracker
Sponsor
Lanzhou University Second Hospital
Phase
Not applicable
Started
2026-01-27
Last updated
2026-11-04

Condition(s) studied

Unexplained Pregnancy Loss

Investigational drug(s) / intervention(s)

Intrauterine Insemination (IUI)

Intrauterine 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.

Study 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 706 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.

Eligibility

Sex
FEMALE
Min age
20 Years
Max age
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.

Primary outcome measure(s)

  • 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.

Trial sites (3)

FacilityCityRegionStatus
Beijing Amcare Beisanhuan Women's & Children's Hospital Beijing Beijing Municipality Not Yet Recruiting
Lanzhou university second hosipital Lanzhou Gansu Recruiting
Hebei Reproductive Health Hospital Shijiazhuang Hebei Not Yet Recruiting

More Lanzhou University Second Hospital trials in China

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Clinical Validation of a Blood Loss Monitoring System Enrolling by invitation
Effects of Enhanced External Counterpulsation Combined With Cardiac Rehabilitation in Patients With Atrial Fibrillation Starting soon
Effect of Negative Pressure Suction on Fluid Absorption and Infection in Flexible Ureteroscopy Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07759609 on ClinicalTrials.gov ↗ ← All trials in China