CompletedPhase 1/2

Low-dose Interleukin-2 in Women With Unexplained Miscarriages

France18 participantsStarted 2021-01-05

Plain-language summary

The purpose of this study is to demonstrate the ability of low dose IL-2 to stimulate peripheral blood Tregs of women with unexplained repeated early spontaneous miscarriages for development of a therapy to prevent fetal rejection by low dose IL-2.

Who can participate

Age range

18 Years – 40 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 pn…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Variation of rate of blood circulating T regulator lymphocytes(expressed in % of CD4 and total)

Timeframe: At the day 38 of Cycle 2 (each cycle is 28 days) compared from the day 10 of Cycle 1]

Variation of rate of blood circulating T regulator lymphocytes(expressed in % of CD4 and total)

Timeframe: At the day 66 of Cycle 2 (each cycle is 28 days) compared from the day 10 of Cycle 1

Variation of rate of blood circulating T regulator lymphocytes(expressed in % of CD4 and total)

Timeframe: At the day 94 of Cycle 2 (each cycle is 28 days) compared from the day 10 of Cycle 1

Variation of rate of blood circulating T regulator lymphocytes(expressed in % of CD4 and total)

Timeframe: At the day 122 of Cycle 2 (each cycle is 28 days) compared from the day 10 of Cycle 1

Variation of rate of blood circulating T regulator lymphocytes(expressed in % of CD4 and total)

Timeframe: At the day 150 of Cycle 2 (each cycle is 28 days) compared from the day 10 of Cycle 11

Trial details

NCT IDNCT03970954

SponsorAssistance Publique - Hôpitaux de Paris

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-07-28

View on ClinicalTrials.gov More Recurrent Miscarriage trials