Unexplained Pregnancy LossNCT07759609
Effect of Intrauterine Insemination on Subsequent Pregnancy Outcomes in Couples With Unexplained Pregnancy Loss: A Multicenter, Open-label, Randomized Controlled Trial
A study testing Intrauterine Insemination (IUI) in people with Unexplained Pregnancy Loss, run by Lanzhou University Second Hospital at 3 sites in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 20 to 37 years, women only
- Conditions the study is for
- Unexplained Pregnancy Loss
- What is being tested?
- Intrauterine Insemination (IUI)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 706 participants
- Where
- 3 sitesChina
- Study dates
- 27 Jan 2026to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 37 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China3 sites, 3 recruiting
- Not yet recruiting
Beijing Amcare Beisanhuan Women's & Children's Hospital
Beijing, Beijing Municipality
Xinna Chen, +8613501207016, xinnachen70@hotmail.com
- Recruiting
Lanzhou university second hosipital
Lanzhou, Gansu
Fang Wang, PhD, +86 13919302888, ery_fwang@lzu.edu.cn
- Not yet recruiting
Hebei Reproductive Health Hospital
Shijiazhuang, Hebei
Lirong Du, +86 18533118669, lirongdu@sina.cn
About this study
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.
- Conditions
- Unexplained Pregnancy Loss
- Being tested
- Intrauterine Insemination (IUI)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intrauterine Insemination (IUI)Procedure or surgery
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 group | Role | What they receive |
|---|---|---|
| Natural Conception | No intervention | Participants attempt natural conception without intrauterine insemination. |
| Intrauterine Insemination (IUI) | Experimental | Participants undergo intrauterine insemination after randomization to improve the probability of conception. Receives: Procedure: Intrauterine Insemination (IUI) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Early Miscarriage Rate
The proportion of women who experience pregnancy loss before 10 weeks of gestation among those achieving pregnancy.
Measured: From randomization until 10 weeks of gestation
Secondary outcomes (4)
Clinical Pregnancy Rate
Clinical pregnancy confirmed by ultrasonographic visualization of an intrauterine gestational sac.
Measured: From randomization until clinical pregnancy assessment (6-8 weeks of gestation)
Live Birth Rate
Delivery of a live infant after 24 weeks of gestation.
Measured: From randomization until delivery (approximately 40 weeks of gestation)
Preterm Birth Rate
Delivery occurring between 28 and 37 completed weeks of gestation.
Measured: 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.
Measured: From enrollment until completion of study follow-up (approximately 40 weeks of gestation)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2026
- Study start27 Jan 2026
- Primary completion1 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Unexplained Pregnancy LossStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 706 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lanzhou University Second Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fang Wang, Lanzhou University Second Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07759609
- Sponsor's protocol ID
- 2025A-1361
- Status last verified
- Nov 2026
- First submitted
- 23 Jul 2026
- Last updated
- 4 Nov 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Intrauterine Insemination on Subsequent Pregnancy Outcomes in Couples With Unexplained Pregnancy Loss: A Multicenter, Open-label, Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07759609
- Acronym / sponsor ID
- 2025A-1361
- Conditions
- Unexplained Pregnancy Loss
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 706 participants (estimated)
- Lead sponsor
- Lanzhou University Second HospitalUniversity, hospital or other
- Study start
- 27 Jan 2026 (actual)
- Primary completion
- 1 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 12 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Natural Conception | No intervention | –Participants attempt natural conception without intrauterine insemination. |
| Intrauterine Insemination (IUI) | Experimental | Procedure: Intrauterine Insemination (IUI)Participants undergo intrauterine insemination after randomization to improve the probability of conception. |
Who may qualify
- Ages
- 20 to 37 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Procedure or surgery | Intrauterine Insemination (IUI) |
Primary outcome
Early Miscarriage Rate
Time frame: From randomization until 10 weeks of gestation
The proportion of women who experience pregnancy loss before 10 weeks of gestation among those achieving pregnancy.
4 secondary outcomes
Clinical Pregnancy Rate
Time frame: From randomization until clinical pregnancy assessment (6-8 weeks of gestation)
Live Birth Rate
Time frame: From randomization until delivery (approximately 40 weeks of gestation)
Preterm Birth Rate
Time frame: From randomization until delivery (approximately 40 weeks of gestation)
Adverse Event Rate
Time frame: From enrollment until completion of study follow-up (approximately 40 weeks of gestation)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intrauterine Insemination (IUI) in people with Unexplained Pregnancy Loss, run by Lanzhou University Second Hospital at 3 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Fang Wang, PhD (+86 13919302888, ery_fwang@lzu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Early Miscarriage Rate (time frame: From randomization until 10 weeks of gestation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2026.