Endometrial Immune Profile in Recurrent Implantation Failure
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18-40
SponsorKing's College London
About this trial
The goal of this observational study is to learn whether differences in the immune cells of the womb lining (endometrium) help explain why some women do not become pregnant despite several IVF attempts using good-quality embryos, a condition known as recurrent implantation failure (RIF). The study compares women with RIF to women who have had a natural, healthy pregnancy. The main question it aims to answer is:
Do immune cells in the endometrium, including uterine natural killer cells, macrophages, B cells, and T cells, differ in number or function between women with RIF and fertile controls?
Researchers will compare endometrial tissue and blood samples from the RIF group to samples from the fertile control group to see whether specific immune cell patterns are linked to implantation failure, and whether these differences could point to future treatment targets.
Participants will:
* Attend a consent appointment to discuss the study * Have a transvaginal ultrasound scan, if one has not already been done in the past 6 months * Confirm the timing of their cycle using a home ovulation test, an ultrasound scan, and a blood test * Have an endometrial tissue sample and a blood sample taken at the point in their cycle when the womb lining would normally be ready to accept an embryo
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Meets ESHRE threshold for recurrent implantation failure (failure to achieve pregnancy despite an estimated cumulative chance of implantation exceeding 60%)
Age under 40
Regular menstrual cycles (24 to 38 days)
Normal transvaginal ultrasound scan
Disqualifiers
Age 40 or above
Actively trying to conceive during the study/biopsy cycle
Significant uterine pathology (e.g. fibroid uterus, abnormal uterine shape, adenomyosis, large Caesarean section defect)
Endometriosis
Trial population
Women under 40 with recurrent implantation failure following IVF, identified through clinical records at King's Fertility (Denmark Hill and Harley Street), and women with a history of spontaneous pregnancy resulting in live birth, identified through 36-week gestation scan records at the Harris Birthright Centre, King's College Hospital. Both groups are drawn from patients already attending these services, approached by their direct care team if they have previously consented to research contact.
Trial design
Design model
Case-control
Time perspective
Cross-sectional
Treatments tested in this trial
Not listed
Trial groups
64 Participants
are grouped into 2 trial groupsGroup A: Recurrent implantation failure (RIF)
Group B: Fertile controls
Trial outcomes
Primary outcomes
1
Th17/Treg ratio in the endometrium
Ratio of T helper 17 (Th17) cells to regulatory T (Treg) cells in endometrial tissue, measured by flow cytometry and single-cell RNA sequencing/CITE-seq, compared between participants with recurrent implantation failure (RIF) and fertile controls.
Time frame
Through study completion, up to 27 monthsSecondary outcomes
1
Reference atlas of endometrial immune cell populations
High-resolution profiling of endometrial-resident immune cell populations, including uterine natural killer cells, macrophages, B cells, and T cells, by single-cell RNA sequencing and CITE-seq, to identify transcriptomic and phenotypic patterns associated with implantation failure.
Time frame
Through study completion, up to 27 months2
Candidate immune targets for future therapeutic research
Identification of immune cell populations, activation states, or clonal T-cell expansions that covary with the Th17/Treg axis and may represent candidate targets for future therapeutic research in recurrent implantation failure.
Time frame
Through study completion, up to 27 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
King's College London
Lead sponsor
King's College Hospital NHS Trust
Collaborator
Rosetrees Trust
Collaborator
The Stoneygate Trust
Collaborator
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: