Embryo DisorderNCT04736160
Pilot Study: hCG Secreted by Blastocyst as Potential Marker of Embryo Quality
An observational study of Embryo Disorder, run by IVI Vigo at 1 site in Spain.
Trial summary
hCG is a hormone produced very early by the pre-embryo, but not by the oocyte. It has a pivotal role in the trophoblast differentiation, and embryo implantation as well as the corpus luteum support. In spite of its well-known role, the literature about it is scarce. Read more about this study
- Who is it for?
- Ages 18 to 41 years, women only
- Conditions the study is for
- Embryo Disorder
- What is being tested?
- collect data
- How many people
- 60 participants
- Where
- 1 siteSpain
- Study dates
- 5 Dec 2018to 25 Nov 2021
- 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 18 to 41 years
- Women only
- Adult
Study population: Patients undergoing IVF with indication of PGT-A and time-lapse evaluation
Who may be able to join
- Age < 42.
- BMI < 30kg/m2.
- SET (Single embryo transfer)
Who cannot join
- Hydrosalpinx.
- Any indication of oocyte vitrification
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
IVI Vigo
Vigo, Pontevedra, 36203
Esther Taboas
About this study
hCG is a hormone produced very early by the pre-embryo, but not by the oocyte. It has a pivotal role in the trophoblast differentiation, and embryo implantation as well as the corpus luteum support. In spite of its well-known role, the literature about it is scarce.
The aim of this study is to evaluate the relation between the amount of hCG secreted by the blastocyst and embryo euploidy status and morphological pre-embryo quality according to morphokinetic pattern.
Read more
We will analyse the amount of hCG secreted by blastocyst to the culture medium thorough mass spectrometry and it will be correlated with the main morphokinetic issues and the chromosomal structure after NGS analysis at blastocyst stage.
We will take the pre-embryo spent culture medium that has been discarded after embryo culture without any interference on the pre-embryo neither any different deviation of standard protocol of embryo manipulation. Furthermore, the evaluation by time-lapse technology will let to document the main issues of embryo development, also without any deviation of the standard protocol.
We are waiting to find the value of hCG secreted by blastocyst as a potential marker of embryo quality and ploidy status.
Read the detailed description
Embryo selection based on morphological and morphokinetic characteristics seems to be insufficient to guarantee implantation. For this reason, in recent years, it has appeared new embryo selection strategies to increase the success of assisted reproduction treatments.
Human chorionic gonadotrophin (hCG) is a glycoprotein hormone composed of two subunits, alpha and beta, non-covalently attached. It is secreted by the blastocyst trophoblastic cells and because it is detectable in maternal blood shortly after embryo implantation and it can be used as a pregnancy marker (Cole et al., 1987).
Historically, it has been believed that the only function of hCG was to stimulate the secretion of progesterone by the corpus luteum. Nowadays, we know that it also plays a key role in the invasion, fusion of the endometrium by the blastocyst and the angiogenesis. In addition, it has a paracrine role to induce trophoblast differentiation (Cole, 2009).
Recently, it has been proposed that its concentration would be linked to the time after implantation and to the number of trophoblastic cells (Tanbo and Eskild, 2015). However, the concentration of hCG shows considerable variations among embryos, and it has been postulated that this could be due to differences in the implantation potential at the second week of embryo development (Lopata and Oliva, 1993). Then, hCG could be a good marker in embryo selection. In fact, it is already known that there is a higher secretion of hCG by those blastocysts that present more adherence to the culture plate compare with those that do not present it (Dokras et al., 1991).
In addition, this hormone presents variants that change as the blastocyst grows. The early embryos secreted more acidic variants than the more advanced ones (Lopata, 1997), and it has recently been shown that the different isoforms correspond to different degrees of glycosylation and metabolic degradation. The measurement of the concentration of these isoforms can be indicate to predict embryo implantation (Butler et al., 2013).
Despite all this, there are few studies published that measure the concentration of hCG in the culture medium and most of them are published more than 15 years ago (Hay and Lopata, 1988; Lopata and Hay, 1989; Dokras et al., 1991; Lopata and Oliva 1993). This fact, together with the need to optimize the embryo classification, makes us consider whether it could be a good candidate as an embryo/aneuploidy selection marker.
- Conditions
- Embryo Disorder
- Being tested
- collect data
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
collect dataOther
The data for this project will be obtained directly from the IVI digital work platform (SIVIS) where the characteristics and scans performed to each patient are recorded. Furthermore, it will be recollected information from the time-lapse incubator. For the current study will be used Embryoscope and Geri time-lapse incubators
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the relation between the amount of hCG secreted by blastocyst and morphological embryo quality according to morphokinetic pattern.
hCG secreted by blastocyst as a potential marker of embryo quality and ploidy status.
Measured: Since 2018 to april 2020
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2021
- Study start5 Dec 2018
- Primary completion25 Nov 2019
- Study completion25 Nov 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Embryo DisorderStudies 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
- Retrospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IVI Vigo
- Sponsor type
- University, hospital or other
- Collaborators
- Instituto Valenciano de Infertilidad, IVI VALENCIA
- Responsible party
- Sponsor
- Investigators
- Elkin Muñoz, Study director, IVI Vigo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04736160
- Sponsor's protocol ID
- 1709-VGO-092-EM
- Status last verified
- Jan 2021
- First submitted
- 29 Jan 2021
- Last updated
- 4 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Basile N, Vime P, Florensa M, Aparicio Ruiz B, Garcia Velasco JA, Remohi J, Meseguer M. The use of morphokinetics as a predictor of implantation: a multicentric study to define and validate an algorithm for embryo selection. Hum Reprod. 2015 Feb;30(2):276-83. doi: 10.1093/humrep/deu331. Epub 2014 Dec 19.
PubMed 25527613Dominguez F, Gadea B, Esteban FJ, Horcajadas JA, Pellicer A, Simon C. Comparative protein-profile analysis of implanted versus non-implanted human blastocysts. Hum Reprod. 2008 Sep;23(9):1993-2000. doi: 10.1093/humrep/den205. Epub 2008 Jun 12.
PubMed 18556682Meseguer M, Herrero J, Tejera A, Hilligsoe KM, Ramsing NB, Remohi J. The use of morphokinetics as a predictor of embryo implantation. Hum Reprod. 2011 Oct;26(10):2658-71. doi: 10.1093/humrep/der256. Epub 2011 Aug 9.
PubMed 21828117
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study: hCG Secreted by Blastocyst as Potential Marker of Embryo Quality
- ClinicalTrials.gov ID
- NCT04736160
- Acronym / sponsor ID
- 1709-VGO-092-EM
- Conditions
- Embryo Disorder
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- IVI VigoUniversity, hospital or other
- Collaborators
- Instituto Valenciano de Infertilidad, IVI VALENCIA
- Study start
- 5 Dec 2018 (actual)
- Primary completion
- 25 Nov 2019 (actual)
- Study completion
- 25 Nov 2021 (estimated)
- First posted
- 3 Feb 2021 (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.
hCG is a hormone produced very early by the pre-embryo, but not by the oocyte. It has a pivotal role in the trophoblast differentiation, and embryo implantation as well as the corpus luteum support. In spite of its well-known role, the literature about it is scarce.
The aim of this study is to evaluate the relation between the amount of hCG secreted by the blastocyst and embryo euploidy status and morphological pre-embryo quality according to morphokinetic pattern.
We will analyse the amount of hCG secreted by blastocyst to the culture medium thorough mass spectrometry and it will be correlated with the main morphokinetic issues and the chromosomal structure after NGS analysis at blastocyst stage.
We will take the pre-embryo spent culture medium that has been discarded after embryo culture without any interference on the pre-embryo neither any different deviation of standard protocol of embryo manipulation. Furthermore, the evaluation by time-lapse technology will let to document the main issues of embryo development, also without any deviation of the standard protocol.
We are waiting to find the value of hCG secreted by blastocyst as a potential marker of embryo quality and ploidy status.
Detailed description
Embryo selection based on morphological and morphokinetic characteristics seems to be insufficient to guarantee implantation. For this reason, in recent years, it has appeared new embryo selection strategies to increase the success of assisted reproduction treatments.
Human chorionic gonadotrophin (hCG) is a glycoprotein hormone composed of two subunits, alpha and beta, non-covalently attached. It is secreted by the blastocyst trophoblastic cells and because it is detectable in maternal blood shortly after embryo implantation and it can be used as a pregnancy marker (Cole et al., 1987).
Historically, it has been believed that the only function of hCG was to stimulate the secretion of progesterone by the corpus luteum. Nowadays, we know that it also plays a key role in the invasion, fusion of the endometrium by the blastocyst and the angiogenesis. In addition, it has a paracrine role to induce trophoblast differentiation (Cole, 2009).
Recently, it has been proposed that its concentration would be linked to the time after implantation and to the number of trophoblastic cells (Tanbo and Eskild, 2015). However, the concentration of hCG shows considerable variations among embryos, and it has been postulated that this could be due to differences in the implantation potential at the second week of embryo development (Lopata and Oliva, 1993). Then, hCG could be a good marker in embryo selection. In fact, it is already known that there is a higher secretion of hCG by those blastocysts that present more adherence to the culture plate compare with those that do not present it (Dokras et al., 1991).
In addition, this hormone presents variants that change as the blastocyst grows. The early embryos secreted more acidic variants than the more advanced ones (Lopata, 1997), and it has recently been shown that the different isoforms correspond to different degrees of glycosylation and metabolic degradation. The measurement of the concentration of these isoforms can be indicate to predict embryo implantation (Butler et al., 2013).
Despite all this, there are few studies published that measure the concentration of hCG in the culture medium and most of them are published more than 15 years ago (Hay and Lopata, 1988; Lopata and Hay, 1989; Dokras et al., 1991; Lopata and Oliva 1993). This fact, together with the need to optimize the embryo classification, makes us consider whether it could be a good candidate as an embryo/aneuploidy selection marker.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 41 years
- Sex
- Female only
- Age groups
- Adult
- Study population
- Patients undergoing IVF with indication of PGT-A and time-lapse evaluation
Key inclusion criteria (3 listed)
- Age < 42.
- BMI < 30kg/m2.
- SET (Single embryo transfer)
Key exclusion criteria (2 listed)
- Hydrosalpinx.
- Any indication of oocyte vitrification
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 |
|---|---|---|
| collect dataThe data for this project will be obtained directly from the IVI digital work platform (SIVIS) where the characteristics and scans performed to each patient are recorded. Furthermore, it will be recollected information from the time-lapse incubator. For the current study will be used Embryoscope and Geri time-lapse incubators | Other | – |
Primary outcome
To evaluate the relation between the amount of hCG secreted by blastocyst and morphological embryo quality according to morphokinetic pattern.
Time frame: Since 2018 to april 2020
hCG secreted by blastocyst as a potential marker of embryo quality and ploidy status.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2021.
- Background: PubMed 25527613Basile N, Vime P, Florensa M, Aparicio Ruiz B, Garcia Velasco JA, Remohi J, Meseguer M. The use of morphokinetics as a predictor of implantation: a multicentric study to define and validate an algorithm for embryo selection. Hum Reprod. 2015 Feb;30(2):276-83. doi: 10.1093/humrep/deu331. Epub 2014 Dec 19.
- Background: PubMed 18556682Dominguez F, Gadea B, Esteban FJ, Horcajadas JA, Pellicer A, Simon C. Comparative protein-profile analysis of implanted versus non-implanted human blastocysts. Hum Reprod. 2008 Sep;23(9):1993-2000. doi: 10.1093/humrep/den205. Epub 2008 Jun 12.
- Background: PubMed 21828117Meseguer M, Herrero J, Tejera A, Hilligsoe KM, Ramsing NB, Remohi J. The use of morphokinetics as a predictor of embryo implantation. Hum Reprod. 2011 Oct;26(10):2658-71. doi: 10.1093/humrep/der256. Epub 2011 Aug 9.
- Individual participant dataSharing planned: Undecided
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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.
Elkin Muñoz study director
IVI Vigo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Embryo Disorder, run by IVI Vigo at 1 site in Spain.
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 3 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: status not confirmed, as of the sponsor's last update on 4 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Elkin Muñoz (986021860, elkin.munoz@ivirma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate the relation between the amount of hCG secreted by blastocyst and morphological embryo quality according to morphokinetic pattern. (time frame: Since 2018 to april 2020). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04736160, which also lists 3 linked publications.
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 4 Feb 2021.