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 type | Interventional |
|---|---|
| Ages | 20 Years to 37 Years |
| Sex | Women only |
| Enrollment | 706 (estimated) |
| Sponsor | Lanzhou University Second Hospital Academic / other |
| Locations | 3 sites (Beijing, Beijing Municipality and 2 other locations) |
| Status | Recruiting |
| Started | January 27, 2026 |
| Main results expected | December 1, 2027 |
| Study ends | December 31, 2027 |
| Registry record updated | November 4, 2026 |
| Trial ID | NCT07759609 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
- Study coordinator: Fang Wang, PhD
- Email: ery_fwang@lzu.edu.cn
- Phone: +86 13919302888
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Fast- vs slow-absorbing sutures in ultra tension-reducing closure
This study tests whether slow-absorbing sutures lead to better scar outcomes than fast-absorbing sutures in a single patient at a time after a linear surgical incision.
-
Irrigation Fluid Absorption and Perioperative cfDNA Changes in TURBT for Bladder Cancer
This study tests whether the amount of irrigation fluid absorbed during TURBT is linked to changes in tumor DNA circulating in the blood in patients with bladder cancer.
-
Negative-pressure suction during flexible ureteroscopy to reduce fluid absorption and infections
This test will see if using a negative-pressure suction sheath during retrograde intrarenal surgery for adults with kidney stones reduces how much irrigation fluid their bodies absorb and lowers the risk of postoperative infections.
-
Doxycycline with or without progestin for chronic endometritis in women with recurrent reproductive failure
This trial tests whether adding the progestin medroxyprogesterone acetate to doxycycline improves pregnancy outcomes for women with chronic endometritis and recurrent reproductive failure.
-
Mass spectrometry test to detect multiple gene mutations in bladder cancer
This project will try a nucleic-acid mass spectrometry test on tumor and matched normal tissue to detect many clinically relevant gene mutations in adults with bladder cancer.
-
Enhanced recovery after laparoscopic distal gastrectomy without routine abdominal drainage tubes
This trial will test whether skipping routine abdominal drainage tubes during enhanced recovery after laparoscopic distal gastrectomy helps adults (18–80) with gastric adenocarcinoma recover as well as using drains.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.