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New treatment option for Repeated Embryo Implantation Failure
Official title Immune Profile Analysis and Biomarker Identification in Women With Repeated Implantation Failure or Unexplained Recurrent Spontaneous Miscarriage
ClinicalTrials.gov ID: NCT05648136
What this study is testing
What is blood sample?
blood sample is an investigational medicine, being studied as a potential treatment for repeated embryo implantation failure.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Implantation is a determining step in human reproduction which requires the transition from a pro-inflammatory state to an anti-inflammatory state allowing the implantation of a competent embryo within a receptive endometrium, and then the maternal immunotolerance towards the alloantigenic fetus. Repeat implantation failures (RIFs), that refers to the fail to achieve a clinical pregnancy after the transfer of at least 3-4 good quality embryos or two blastocysts, and unexplained recurrent spontaneous miscarriage (RM) (≥2-3) could be related in some patients to immune imbalances characterized by an excessive and prolonged inflammatory response and/or a defect of anti-inflammatory regulation.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 39, women only. Healthy volunteers may be eligible.
You may be able to join if
- 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...
- women with a basal FSH level \ 1.5ng/ml
You likely can't join if
- Ongoing pelvic and/or systemic infection
- Chronic infectious endometritis
- Active neoplasia
- Autoimmune and autoinflammatory disease
- Celiac disease
- Thrombophilia (including positive anti-phospholipid antibodies)
See the full eligibility 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 \ 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...
- 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...
- 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.
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Amiens, Picardie, France
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years to 39 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Amiens, Picardie, France. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.