The intrauterine environment during the luteal phase of the menstrual cycle
| ISRCTN | ISRCTN85528745 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN85528745 |
| Sponsors | Vall d´Hebron Research Institute, Manina Medtech SL |
| Funders | Vall d´Hebron Research Institute, Manina Medtech SL |
- Submission date
- 30/01/2026
- Registration date
- 30/01/2026
- Last edited
- 30/01/2026
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Pregnancy and Childbirth
Plain English summary of protocol
Background and study aims
Embryo implantation often fails in in vitro fertilization (IVF) treatments, depending on both embryo quality and endometrial receptivity. Nowadays, high-quality embryos can be produced and selected, but the uterine readiness for embryo implantation is a long-overlooked need in the field. We want to collect first-human data of the intrauterine oxygenation profiles of women during their menstrual cycles, to study if this parameter could be useful to assess endometrial receptivity.
Who can participate?
Healthy volunteers aged between 18 and 35 years with regular menstrual cycles
What does the study involve?
At-home daily urine testing for a week, around 6-7 visits for intrauterine measurement, vaginal ultrasound and blood analysis.
What are the possible benefits and risks of participating?
Participants will not directly benefit from taking part in this study. There is a small risk of infection because a catheter will be placed in the uterus. This risk will be kept as low as possible by using sterile equipment and clean procedures.
Where is the study run from?
Vall d'Hebron University Hospital (Spain)
When is the study starting and how long is it expected to run for?
January 2022 to June 2022
Who is funding the study?
1. The Vall d'Hebron Research Institute (Spain)
2. Manina Medtech SL (Spain)
Who is the main contact?
Dr Melchor Carbonell, melchor.carbonell@vallhebron.cat
Contact information
Principal investigator, Public
Pg. de la Vall d'Hebron, 119, Horta-Guinardó
Barcelona
08035
Spain
| Phone | +34 (0)934893177 |
|---|---|
| melchor.carbonell@vallhebron.cat |
Public, Scientific
Pg. de la Vall d'Hebron, 119, Horta-Guinardó
Barcelona
08035
Spain
| Phone | +34 (0)934893177 |
|---|---|
| anna.teixido@vallhebron.cat |
Scientific
Bruc 35 4-2A
Barcelona
08010
Spain
| Phone | +34 (0)645433894 |
|---|---|
| monica.delavega@maninamedtech.com |
Study information
| Primary study design | Interventional | |
|---|---|---|
| Allocation | N/A: single arm study | |
| Masking | Open (masking not used) | |
| Control | Uncontrolled | |
| Assignment | Single | |
| Purpose | Basic science, Device feasibility | |
| Scientific title | The pattern of an intrauterine biophysical parameter as an indicator of the implantation window: a feasibility study | |
| Study acronym | PR(AMI)336/2021 | |
| Study objectives | To explore intrauterine oxygen patterns as a potential marker of endometrial readiness for embryo implantation. | |
| Ethics approval(s) |
Approved 15/10/2021, Comité De Ética De Investigación Con Medicamentos Del Hospital Universitari Vall d'Hebron (Pg. de la Vall d'Hebron, 119, Horta-Guinardó, Barcelona, 08035, Spain; +34 (0)934893000; ceic@vhir.org), ref: PR(AMI)336/2021 | |
| Health condition(s) or problem(s) studied | Endometrial readiness for embryo implantation | |
| Intervention | During the luteal phase in healthy volunteers, intrauterine oxygen pressure is measured every 48 hours using the methodology described by Otossen et al. in "Observations on intrauterine oxygen tension measured by fibre-optic microsensors". Reproductive BioMedicine Online, 2006, 13(3), 380–385 The study also includes blood sampling and transvaginal ultrasound. | |
| Intervention type | Device | |
| Phase | Not Applicable | |
| Drug / device / biological / vaccine name(s) | Seedchrony | |
| Primary outcome measure(s) |
| |
| Key secondary outcome measure(s) | ||
| Completion date | 30/06/2022 |
Eligibility
| Participant type(s) | |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 35 Years |
| Sex | Female |
| Target sample size at registration | 8 |
| Total final enrolment | 8 |
| Key inclusion criteria | 1. Female 2. Healthy 3. 18-35 years old 4. Regular menstrual cycles 5. BMI below 30 kg/m2 |
| Key exclusion criteria | 1. Medical pathology: insulin-dependent diabetes mellitus, Cushing’s syndrome, uncontrolled thyroid dysfunction, hepatic and/or renal insufficiency, any condition contraindicating ovarian stimulation and/or pregnancy, antiphospholipid syndrome 2. Uterine pathology: endometriosis, uterine cancer, congenital malformations, endometrial polyps, uterine fibroids 3. Current smoker 4. Use of oral contraceptives or intrauterine device within the last 3 months 5. Inadequate understanding (oral and written) of the Spanish language |
| Date of first enrolment | 10/01/2022 |
| Date of final enrolment | 01/06/2022 |
Locations
Countries of recruitment
- Spain
Study participating centre
Barcelona
08035
Spain
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not expected to be made available |
| IPD sharing plan |
Editorial Notes
30/01/2026: Study's existence confirmed by the Comité De Ética De Investigación Con Medicamentos Del Hospital Universitari Vall d'Hebron.
