Infertility (IVF Patients)CONNECTEDNCT06780605
Correlation of the Genetic Constitution of the Spent Blastocyst Media
An observational study of Infertility (IVF Patients), run by Igenomix at 2 sites in Cyprus.
Trial summary
The main objective of this study is to improve niPGT-A (non-invasive Preimplantation Genetic Testing for Aneuploidies) to avoid the need of a biopsy to perform the genetic analysis of the embryo and to help in understanding the genetic constitution of different parts of the blastocyst (early stage of an embryo… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Infertility (IVF Patients)
- What is being tested?
- niPGT-A and Multifocal TE biopsies and ICM biopsy
- How many people
- 230 participants
- Where
- 2 sitesCyprus
- Study dates
- 1 Oct 2024to 7 Nov 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Donated embryos to research from patients undergoing IVF/ICSI or PGT-A cycles will be eligible for the study after informed consent signature.
Who may be able to join
- Study informed consent form, approved by the Ethics Committee, signed.
- Any patient with aneuploid or euploid blastocysts from PGT-A cycles donated for research.
- Patients undergoing regular IVF/ICSI cycles aiming to donate surplus embryos for research.
- Embryos from own or donated oocytes can be included.
- Embryos fertilized with donated sperm can be included.
- Only blastocysts with proper re-expansion and good quality after thawing will be included.
Who cannot join
- Blastocysts that had not survived to vitrification, that had not re-expanded properly or having poor ICM or TE quality.
- Note: No exclusion criteria specific to the patients' background will be considered.
Trial locations and contacts
2 sites in 1 country.
Cyprus2 sites
British Cyprus IVF Hospital
Nicosia, 2681
Ventus IVF Center
Nicosia, 99010
About this study
Official title: Observational Study to Investigate the Correlation of the Genetic Constitution of the Spent Blastocyst Media (SBM) With the Inner Cell Mass (ICM) and Multifocal Trophectoderm (TE) Biopsies
The main objective of this study is to improve niPGT-A (non-invasive Preimplantation Genetic Testing for Aneuploidies) to avoid the need of a biopsy to perform the genetic analysis of the embryo and to help in understanding the genetic constitution of different parts of the blastocyst (early stage of an embryo development).
For this purpose, we aim to analyses the genetic material released by the embryo to the culture medium (also called Spent Blastocyst Media, SBM) from about 200 blastocysts donated to research by participants of assisted reproduction treatments.
The results will be correlated with the ones obtained from performing the same analysis on biopsies taken from the outer (trophectoderm, TE) and the inner (inner cell mass, ICM) layer of cells in different locations to investigate the mechanisms and origin of the blastocyst genetic content released to the culture medium during preimplantation embryo development.
Read the detailed description
The study and selection of embryos before transfer is a key step for the success of infertility treatments in assisted reproduction. The current techniques applied are called preimplantation genetic testing of aneuploidies (PGT-A) and are highly sensitive and specific, although they require the retrieval of four to six cells (a biopsy) from an embryo at an early stage of development (blastocyst stage).
Nowadays, the alternatives for embryo selection given to young and healthy women or to couples that do not want to undergo PGT-A are based on studying the morphology and development of the embryos. Unfortunately, these are not reliable methods to know if the embryos have the right number of chromosomes.
A new method called non-invasive PGT-A (niPGT-A) analyses the genetic material released by the embryo to the culture medium (Spent Blastocyst Media, SBM) where the embryo grows in the IVF lab. This genetic material allows for identification of the chromosome number of the embryo. In a previous pilot study, the results of the analysis of the culture media were concordant with the results of the embryo biopsy in 85% of cases.
The current study will analyze the genetic constitution of the SBM and correlate the results of the same analysis on the inner cell mass (ICM) and trophectoderm (TE) cells taken in different locations (multifocal biopsy) to improve our understanding of the mechanisms and origin of the embryo genetic content released to the culture medium during its preimplantational development.
Once this prospective and observational study is approved by the competent Research Ethics Committee, the recruitment and selection of patients will follow. Every potential participant will be asked to sign the study informed consent only after finishing their assisted reproductive treatment.
To comply with the design of this pilot study, a total number of 200 blastocysts donated to research after IVF/ICSI or PGT-A cycles has been estimated to generate enough results. After warming, blastocysts will be subjected to multifocal biopsies of TE, ICM isolation and collection of the SBM. This part of the study will be performed in the collaborating centers. Samples will be shipped to Igenomix Spain for the genetic research and further data analysis.
The expected duration of the study is 18 months. Embryos will be included in the different participating centers for an estimated period of 9 months. Participants involvement in the study is just linked to the moment of the consent form signature for the embryo donation. This study will not imply any modification of a scheduled IVF/ICSI or PGT-A cycles nor extra visits to the recruiting centers.
- Conditions
- Infertility (IVF Patients)
- Being tested
- niPGT-A, Multifocal TE biopsies and ICM biopsy
- Keywords
- PGT-A, Trophectoderm, Inner cell mass, Blastocyst, Infertility, In vitro fertilization, niPGT-A, Embryo development, Embryonic cell-free DNA, Embryo selection
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
niPGT-AGenetic
After being thawed following the standard lab practice, any donated blastocyst usable for the study will be washed individually to remove any trace of cumulus DNA and will be transferred to a new culture dish with a drop of 10-15µl. Day-5 blastocysts with proper re-expansion after thawing, will be cultured overnight (≈24 hours) before media collection and TE/ICM biopsies. Day-6 blastocysts will be cultured a total of 8 hours after thawing, before media collection and TE/ICM biopsies.
On day 6/7, the embryos' media will be collected with an automatic pipette for niPGT-A and additional genetic analysis. The same protocol will be used to analyze SBM and blastocyst biopsies.
Multifocal TE biopsies and ICM biopsyGenetic
For biopsy, blastocysts will be transferred to the biopsy dish and multi-focal TE biopsies will be performed in three locations related to the position of the ICM. ICM biopsies will be performed following a published protocol provided to the participant centers. ICM and TE sections will be aspirated with the use of micropipettes adapted to a micromanipulation and laser microscope system.
For the genetic study of the samples, the same protocol will be used to analyze embryo biopsies and SBM.
| Study group | Role | What they receive |
|---|---|---|
| Embryos donated for research after an assisted reproduction treatment | Study specific procedures will start only when the potential participant couples have undergone their scheduled IVF/ICSI and/or PGT-A cycles following clinics´ standard practice to obtain blastocysts that will be vitrified. If they accept to donate the surplus blastocysts not used in their reproductive treatment to the current study by signing the informed consent, lab operators will carry out embryo warming and will select the appropriate blastocysts to go through the study protocol procedures (collection of SBM and TE/ICM biopsies). No drugs or medical devices will be used. Receives: Genetic: niPGT-A; Genetic: Multifocal TE biopsies and ICM biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Chromosomal status of the embryos
Concordance of the genetics results between SBM and TE and ICM biopsies samples analysis results.
Measured: Up to 6/7 days of embryo development
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2025
- Study start1 Oct 2024
- Primary completion7 Nov 2025
- Study completion7 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infertility (IVF Patients)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 230 participants (actual)
Sponsor and investigators
- Lead sponsor
- Igenomix
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pere Mir Pardo, PhD, Principal investigator, IgenomixLuis Navarro Sanchez, PhD, Principal investigator, Igenomix
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06780605
- Sponsor's protocol ID
- IGX1-GCO-CR-23-04
- Acronym
- CONNECTED
- Status last verified
- Jan 2026
- First submitted
- 13 Jan 2025
- Last updated
- 30 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Study to Investigate the Correlation of the Genetic Constitution of the Spent Blastocyst Media (SBM) With the Inner Cell Mass (ICM) and Multifocal Trophectoderm (TE) Biopsies
- ClinicalTrials.gov ID
- NCT06780605
- Acronym / sponsor ID
- CONNECTED / IGX1-GCO-CR-23-04
- Conditions
- Infertility (IVF Patients)
- Keywords
- PGT-A, Trophectoderm, Inner cell mass, Blastocyst, Infertility, In vitro fertilization, niPGT-A, Embryo development
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 230 participants (actual)
- Lead sponsor
- IgenomixIndustry (pharma, biotech, devices)
- Study start
- 1 Oct 2024 (actual)
- Primary completion
- 7 Nov 2025 (actual)
- Study completion
- 7 Nov 2025 (actual)
- First posted
- 17 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The main objective of this study is to improve niPGT-A (non-invasive Preimplantation Genetic Testing for Aneuploidies) to avoid the need of a biopsy to perform the genetic analysis of the embryo and to help in understanding the genetic constitution of different parts of the blastocyst (early stage of an embryo development).
For this purpose, we aim to analyses the genetic material released by the embryo to the culture medium (also called Spent Blastocyst Media, SBM) from about 200 blastocysts donated to research by participants of assisted reproduction treatments.
The results will be correlated with the ones obtained from performing the same analysis on biopsies taken from the outer (trophectoderm, TE) and the inner (inner cell mass, ICM) layer of cells in different locations to investigate the mechanisms and origin of the blastocyst genetic content released to the culture medium during preimplantation embryo development.
Detailed description
The study and selection of embryos before transfer is a key step for the success of infertility treatments in assisted reproduction. The current techniques applied are called preimplantation genetic testing of aneuploidies (PGT-A) and are highly sensitive and specific, although they require the retrieval of four to six cells (a biopsy) from an embryo at an early stage of development (blastocyst stage).
Nowadays, the alternatives for embryo selection given to young and healthy women or to couples that do not want to undergo PGT-A are based on studying the morphology and development of the embryos. Unfortunately, these are not reliable methods to know if the embryos have the right number of chromosomes.
A new method called non-invasive PGT-A (niPGT-A) analyses the genetic material released by the embryo to the culture medium (Spent Blastocyst Media, SBM) where the embryo grows in the IVF lab. This genetic material allows for identification of the chromosome number of the embryo. In a previous pilot study, the results of the analysis of the culture media were concordant with the results of the embryo biopsy in 85% of cases.
The current study will analyze the genetic constitution of the SBM and correlate the results of the same analysis on the inner cell mass (ICM) and trophectoderm (TE) cells taken in different locations (multifocal biopsy) to improve our understanding of the mechanisms and origin of the embryo genetic content released to the culture medium during its preimplantational development.
Once this prospective and observational study is approved by the competent Research Ethics Committee, the recruitment and selection of patients will follow. Every potential participant will be asked to sign the study informed consent only after finishing their assisted reproductive treatment.
To comply with the design of this pilot study, a total number of 200 blastocysts donated to research after IVF/ICSI or PGT-A cycles has been estimated to generate enough results. After warming, blastocysts will be subjected to multifocal biopsies of TE, ICM isolation and collection of the SBM. This part of the study will be performed in the collaborating centers. Samples will be shipped to Igenomix Spain for the genetic research and further data analysis.
The expected duration of the study is 18 months. Embryos will be included in the different participating centers for an estimated period of 9 months. Participants involvement in the study is just linked to the moment of the consent form signature for the embryo donation. This study will not imply any modification of a scheduled IVF/ICSI or PGT-A cycles nor extra visits to the recruiting centers.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Embryos donated for research after an assisted reproduction treatment | – | Genetic: niPGT-A, Genetic: Multifocal TE biopsies and ICM biopsyStudy specific procedures will start only when the potential participant couples have undergone their scheduled IVF/ICSI and/or PGT-A cycles following clinics´ standard practice to obtain blastocysts that will be vitrified. If they accept to donate the surplus blastocysts not used in their reproductive treatment to the current study by signing the informed consent, lab operators will carry out embryo warming and will select the appropriate blastocysts to go through the study protocol procedures (collection of SBM and TE/ICM biopsies). No drugs or medical devices will be used. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Donated embryos to research from patients undergoing IVF/ICSI or PGT-A cycles will be eligible for the study after informed consent signature.
Key inclusion criteria (6 listed)
- Study informed consent form, approved by the Ethics Committee, signed.
- Any patient with aneuploid or euploid blastocysts from PGT-A cycles donated for research.
- Patients undergoing regular IVF/ICSI cycles aiming to donate surplus embryos for research.
- Embryos from own or donated oocytes can be included.
- Embryos fertilized with donated sperm can be included.
Key exclusion criteria (2 listed)
- Blastocysts that had not survived to vitrification, that had not re-expanded properly or having poor ICM or TE quality.
- Note: No exclusion criteria specific to the patients' background will be considered.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| niPGT-AAfter being thawed following the standard lab practice, any donated blastocyst usable for the study will be washed individually to remove any trace of cumulus DNA and will be transferred to a new culture dish with a drop of 10-15µl. Day-5 blastocysts with proper re-expansion after thawing, will be cultured overnight (≈24 hours) before media collection and TE/ICM biopsies. Day-6 blastocysts will be cultured a total of 8 hours after thawing, before media collection and TE/ICM biopsies. On day 6/7, the embryos' media will be collected with an automatic pipette for niPGT-A and additional genetic analysis. The same protocol will be used to analyze SBM and blastocyst biopsies. | Genetic | Embryos donated for research after an assisted reproduction treatment |
| Multifocal TE biopsies and ICM biopsyFor biopsy, blastocysts will be transferred to the biopsy dish and multi-focal TE biopsies will be performed in three locations related to the position of the ICM. ICM biopsies will be performed following a published protocol provided to the participant centers. ICM and TE sections will be aspirated with the use of micropipettes adapted to a micromanipulation and laser microscope system. For the genetic study of the samples, the same protocol will be used to analyze embryo biopsies and SBM. | Genetic | Embryos donated for research after an assisted reproduction treatment |
Primary outcome
Chromosomal status of the embryos
Time frame: Up to 6/7 days of embryo development
Concordance of the genetics results between SBM and TE and ICM biopsies samples analysis results.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pere Mir Pardo, PhD principal investigator
Igenomix
Luis Navarro Sanchez, PhD principal investigator
Igenomix
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Infertility (IVF Patients), run by Igenomix at 2 sites in Cyprus.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Cyprus. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Chromosomal status of the embryos (time frame: Up to 6/7 days of embryo development). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2026.