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Could a Low-Dose immune drug stop recurrent miscarriages?

NCT ID NCT03970954

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 25, 2026 · Last updated Jun 26, 2026 · Updated 1 time

Summary

This early trial tested whether low doses of interleukin-2 (IL-2) could boost regulatory T cells in women who had at least five unexplained miscarriages. The goal was to see if this immune-calming approach could eventually prevent the body from rejecting a pregnancy. Only 18 women took part, and the study measured changes in immune cells rather than actual pregnancy success.

What this could mean

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

Active substance
low-dose interleukin-2 (IL-2)
What this could lead to
If it works, this could lead to a treatment that prevents miscarriages by calming the immune system.
What could go wrong
This is a very small, early-phase trial with only 18 participants. It only measured immune cell changes, not pregnancy outcomes, so it may not lead to a proven therapy.

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

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

18 people

The number who actually took part.

Started

Jan 2021

Finished

Mar 2024

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

18 to 40 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: * Woman with at least 5 consecutive early miscarriages less than 14 weeks of amenorrhea and unexplained after the usual check-up; * Volunteer to participate in the trial and having given written consent after appropriate information. Exclusion Criteria: * Uterine or pelvic abnormality: uterine malformation, intracavitary fibroid, synechiae, polyp, hydrosalpinx; * Balanced translocations in both spouses; * Diabetes type I or II; * Sickle cell disease; * Contraindication to pregnancy; * Constitutional or acquired thrombophilia (protein deficit C, S, ATIII, homozygous factor V or II deficiency, antiphospholipid syndrome, antithyroid antibodies positive, celiac disease, hyperhomocysteinemia); * Ovarian insufficiency (AMH \<1 ng/ml); AFC \< 4 * Significant spermogram abnormalities and DNA fragmented more than 30% * Active HIV or HCV infection; * Main known contraindications to treatment with IL-2: * Hypersensitivity to the active substance or to any of the excipients; * Signs of progressive infection requiring antibiotic therapy; * History of organ allograft; * Pre-existing autoimmune disease; * Leukocytes \<4000 / mm3; platelets \<100,000 / mm3; hematocrit \<30%; * hepatic or renal insufficiency; * depression; * significant history or existence of a serious heart disease (in doubtful cases, perform a stress test); * patients with autoimmune disease; * patients with an infection (septicemia, bacterial endocarditis, septic thrombophlebitis, peritonitis and pneumonia); * pregnancy; * Treatment with immunomodulators, immunosuppressants (class L04A of the ATC classification), in particular systemic corticosteroids, as well as aspirin and low molecular weight heparin; * No affiliation to a social security; * Person who has already been included in this study or in another at the same time; * Major incapacitated patient (tutorship / curatorship); * Patient with an allergy to taking IL2-fd; * Participants who would present professional risk factors (eg ionizing exposure);

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Conditions

The condition(s) this trial relates to.

Abortion, Spontaneous habitual spontaneous abortion

As listed by the trial registrant

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

Contacts and locations

Locations

  • Bornes

    Paris, Hopital Tenon, 75020, France

  • Kayem

    Paris, Hopital Trousseau, 75012, France

  • Mekinian

    Paris, Hopital Saint Antoine, 75012, France

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