Could a simple blood test explain why some women Can't carry a pregnancy?
NCT ID NCT05648136
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study is looking at whether immune system imbalances contribute to repeated IVF failure or unexplained miscarriages. Researchers will collect blood samples from 150 women (including healthy controls) to measure immune cell types and inflammatory markers. The goal is to identify biomarkers that could one day help diagnose immune-related pregnancy problems and guide treatment.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- What this could lead to
- If successful, this could lead to a blood test that identifies immune-related causes of pregnancy failure, helping doctors personalize treatment.
- What could go wrong
- This is an observational study, not a treatment trial. It may not find clear biomarkers, and any future test would need much more validation.
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
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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
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About 150 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Aug 2024
- Expected to finish
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Aug 2026
An estimate. End dates often move.
- Lead sponsor
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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
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18 to 39 years
- Sex
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Female participants only
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
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: * For patients : * Women aged 18 to 39 years * women with a history of RIF or unexplained RM * women with a negative diagnostic work-up (including pelvic ultrasound and hysteroscopy, parental karyotype, thyroid function test, and anti-thyroid and anti-phospholipid antibodies) * women with a basal FSH level \<10IU/l and AMH level \>1.5ng/ml * women with a regular menstrual cycle of 30+/-5 days * women receiving a new cycle of in vitro fertilization (IVF) +/- intracytoplasmic sperm injection (ICSI) for patients in the RIF group or a first cycle of IVF +/-ICSI for patients in the RM group * women received written and oral information and signed an informed consent For control groups: * Controls recruited in the Obstetrics and Gynecology Department with at least one live birth after a spontaneous pregnancy (with a time to conception of less than 12 months for each pregnancy) Voluntary oocyte donors recruited within the CECOS de Picardie (having presented at least one live birth with a delay necessary to conceive of less than 12 months) * Controls recruited in the Reproductive Medicine and Biology Department having presented at least one live birth (spontaneous with a delay to conceive of less than 12 months for each pregnancy or after one or two MPA procedures) and benefiting from an IVF+/-ICSI procedure for secondary infertility * Controls recruited in the department of Medicine and Reproductive Biology with a normal infertility assessment and benefiting from an IVF procedure with ICSI on male indication. Exclusion Criteria: * Ongoing pelvic and/or systemic infection * Chronic infectious endometritis * Active neoplasia * Autoimmune and autoinflammatory disease * Celiac disease * Thrombophilia (including positive anti-phospholipid antibodies) * Endocrine pathology (including dysthyroidism and diabetes) * Endometriosis * Polycystic ovary syndrome and ovulatory disorders * Premature ovarian failure * IVF by oocyte donation * Tubal obstructions or lesions, uterine and cervical anomalies * Partners with extreme oligoastheno-spermia and/or sperm DNA fragmentation \>30 * Sperm donations * Patients unable to give informed consent
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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.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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Centre Hospitalier Universitaire d'Amiens
RECRUITINGAmiens, Picardie, 80000, France
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