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Can a simple fertility procedure break the cycle of unexplained pregnancy loss?

NCT ID NCT07759609

Disease control Sponsor: Lanzhou University Second Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 12, 2026 · Last updated Aug 13, 2026 · Updated 1 time

Summary

This trial asks whether intrauterine insemination (IUI) can improve the chances of a successful pregnancy for couples who have experienced unexplained pregnancy loss. It will enroll 558 couples, randomly assigning them to either IUI or natural conception, and track outcomes like early miscarriage, clinical pregnancy, and live birth rates. The goal is to provide clearer evidence on whether IUI should be a standard option for these couples.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Intrauterine insemination (IUI), a procedure where processed sperm is placed directly into the uterine cavity around ovulation to increase the chance of conception.
What this could lead to
If IUI proves effective, it could offer couples with unexplained pregnancy loss a simple, low-tech option to improve their chances of a successful pregnancy.
What could go wrong
This is an early-stage question; IUI may not improve outcomes over natural conception, and the trial's success depends on many factors, including the couple's specific fertility profile.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 558 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jan 2026

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

20 to 37 years

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Unexplained pregnancy loss

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    3 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Beijing Amcare Beisanhuan Women's & Children's Hospital

    NOT_YET_RECRUITING

    Beijing, Beijing Municipality, China

  • Hebei Reproductive Health Hospital

    NOT_YET_RECRUITING

    Shijiazhuang, Hebei, China

  • Lanzhou university second hosipital

    RECRUITING

    Lanzhou, Gansu, China