Could a Low-Dose immune drug stop recurrent miscarriages?
NCT ID NCT03970954
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
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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 Hide 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.
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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