Clinical trial Recruiting at 1 site Interventional Ages 20 to 37 Women only

Can intrauterine insemination help next pregnancies after unexplained pregnancy loss?

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

Run by Lanzhou University Second Hospital · NCT07759609 · Data updated 2026-11-12

This study tests whether intrauterine insemination (IUI) helps couples who have had an unexplained pregnancy loss have successful pregnancies afterward, compared with trying to conceive naturally.

Quick facts

Study typeInterventional
Ages20 Years to 37 Years
SexWomen only
Enrollment706 (estimated)
SponsorLanzhou University Second Hospital
Academic / other
Locations3 sites (Beijing, Beijing Municipality and 2 other locations)
StatusRecruiting
StartedJanuary 27, 2026
Main results expectedDecember 1, 2027
Study endsDecember 31, 2027
Registry record updatedNovember 4, 2026
Trial IDNCT07759609 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Women aged 20-37 with at least one ultrasound-confirmed prior pregnancy loss within the last 12 months, desire for pregnancy, adequate ovarian reserve (FSH < 10 IU/L, AMH > 1.1 ng/mL), and a male partner meeting IUI semen criteria.

Probably not a fit

Couples where the female partner has uterine abnormalities, thyroid dysfunction, positive antiphospholipid antibodies, or parental chromosomal abnormalities may not benefit from this approach.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This multicenter, open-label randomized trial compares IUI to natural conception in couples with a recent unexplained pregnancy loss. About 706 couples will be enrolled and randomly assigned to receive IUI or attempt natural conception, then followed to assess subsequent pregnancy outcomes. The trial aims to provide high-quality evidence on whether IUI improves reproductive outcomes in this population. It is led by Lanzhou University Second Hospital and includes sites in Beijing, Lanzhou, and Shijiazhuang. Results could influence clinical practice for managing unexplained pregnancy loss.

Why it matters

Potential benefit: If successful, the study could support adding IUI as a management option to improve subsequent pregnancy chances for couples after unexplained pregnancy loss.

How similar studies have gone: The effectiveness of IUI in this specific setting is not yet established, making this trial a novel assessment in unexplained pregnancy loss.

Who can join: the full rules

Show full inclusion / exclusion criteria
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.

Where it's running

  • Lanzhou university second hosipital
    Lanzhou, Gansu, China
    Recruiting
  • Beijing Amcare Beisanhuan Women's & Children's Hospital
    Beijing, Beijing Municipality, China
    Not yet recruiting
  • Hebei Reproductive Health Hospital
    Shijiazhuang, Hebei, China
    Not yet recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.