hCGNCT04744519
hCG Concentration in Peripheral Maternal Blood After Embryo Transfer, Ongoing Pregnancy Rates, and Morphokinetics
An observational study of hCG, run by IVI Vigo at 1 site in Spain.
Trial summary
hCG is a hormone produced very early by the 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 32 years, women only
- Conditions the study is for
- hCG
- What is being tested?
- Collect data
- How many people
- 300 participants
- Where
- 1 siteSpain
- Study dates
- 20 Jan 2019to 25 Jun 2019
- 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 32 years
- Women only
- Adult
Study population: Patients who underwent ICSI with oocyte donation in IVI Vigo under time-lapse monitoring between 2013 and up to June 2019.
Who may be able to join
- Donors age < 32.
- IMC< 30kg/m2.
- Antral follicle count higher than 8.
- Single Blastocyst transference.
- 5% oxygen embryo culture,
- time-lapse monitoring incubation KID embryos.
Who cannot join
- Müllerian anomalies,
- Hydrosalpinx.
- Any indication of oocyte vitrification.
- Severe male factor.
- Embryos transferences where a tenaculum was required, or more than one attempt was needed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: hCG Concentration in Peripheral Maternal Blood After Embryo Transfer, Ongoing Pregnancy
hCG is a hormone produced very early by the 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 retrospective study is to evaluate the relationship between the hCG concentration in peripheral maternal blood measured 11 days after embryo transfer, embryo morphokinetics pattern and the abortion and ongoing pregnancy rates.
We will study patients having transference of blastocyst cultured in time lapse monitored incubators and will check all the morphokinetics parameters with the IVI database.
Read the detailed description
Human chorionic gonadotrophin is a two subunits (alpha and beta) glycoprotein hormone secreted by blastocyst trophoblastic cells.
It plays a role in progesterone secretion by corpus luteum, endometrium invasion and fusion by trophoectoderm, angiogenesis, and induction of trophoblast differentiation Shortly after embryo implantation, trophoblastic hCG is detectable in maternal blood, and its concetration depends on the number and functionality of trophoectoderm cells. Therefore, hCG concentration in maternal blood is measured as an early pregnancy marker.
However, hCG concentration in several women showed high variability, and embryo implantation also depends on endometrial receptivity, what means that in early stages, everything affecting endometrial receptivity, may affect hCG concentration.
Early high hCG concentration has been related with higher pregnancy rate and it has been proposed that hCG concentration may be related to the time of embryo implantation and the viable trophoectoderm cell number.
- Conditions
- hCG
- 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
Also called Collect retrospectively data on embryo implantation rate
- Controlled ovarian stimulation with GnRH antagonists effected to the patients in order to get their eggs through follicular puncture, which will be trigger by GnRH analogue. The eggs will be isolated and processed according to the standard protocol.
What is being measured
The primary outcome is the main question the study is designed to answer.
Researchers pretend to correlate the quality of the trophoectoderm and the embryo morphokinetics time with the hCG concentration after 13 days of embryo transfer, and also the implantation and the ongoing pregnancy rate.
- Clinical pregnancy: when the maternal serum levels of β-hCG are higher than 10 UI/L, between 14 and 16 days after the fertilization and the presence of a gestational sac can be appreciated by ultrasound scan a week later (21-23 days after fertilization)
Measured: Since 2013 to april 2019
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2021
- Study start20 Jan 2019
- Primary completion25 Jun 2019
- Study completion25 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for hCGStudies 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
- 300 participants (actual)
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
- NCT04744519
- Sponsor's protocol ID
- 1712-VGO-122-EM
- Status last verified
- Jan 2021
- First submitted
- 29 Jan 2021
- Last updated
- 9 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Basile N, Nogales Mdel C, Bronet F, Florensa M, Riqueiros M, Rodrigo L, Garcia-Velasco J, Meseguer M. Increasing the probability of selecting chromosomally normal embryos by time-lapse morphokinetics analysis. Fertil Steril. 2014 Mar;101(3):699-704. doi: 10.1016/j.fertnstert.2013.12.005. Epub 2014 Jan 11.
PubMed 24424365Dominguez 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 18556682
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- hCG Concentration in Peripheral Maternal Blood After Embryo Transfer, Ongoing Pregnancy
- ClinicalTrials.gov ID
- NCT04744519
- Acronym / sponsor ID
- 1712-VGO-122-EM
- Conditions
- hCG
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- IVI VigoUniversity, hospital or other
- Collaborators
- Instituto Valenciano de Infertilidad, IVI VALENCIA
- Study start
- 20 Jan 2019 (actual)
- Primary completion
- 25 Jun 2019 (actual)
- Study completion
- 25 Jun 2019 (actual)
- First posted
- 9 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 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 retrospective study is to evaluate the relationship between the hCG concentration in peripheral maternal blood measured 11 days after embryo transfer, embryo morphokinetics pattern and the abortion and ongoing pregnancy rates.
We will study patients having transference of blastocyst cultured in time lapse monitored incubators and will check all the morphokinetics parameters with the IVI database.
Detailed description
Human chorionic gonadotrophin is a two subunits (alpha and beta) glycoprotein hormone secreted by blastocyst trophoblastic cells.
It plays a role in progesterone secretion by corpus luteum, endometrium invasion and fusion by trophoectoderm, angiogenesis, and induction of trophoblast differentiation Shortly after embryo implantation, trophoblastic hCG is detectable in maternal blood, and its concetration depends on the number and functionality of trophoectoderm cells. Therefore, hCG concentration in maternal blood is measured as an early pregnancy marker.
However, hCG concentration in several women showed high variability, and embryo implantation also depends on endometrial receptivity, what means that in early stages, everything affecting endometrial receptivity, may affect hCG concentration.
Early high hCG concentration has been related with higher pregnancy rate and it has been proposed that hCG concentration may be related to the time of embryo implantation and the viable trophoectoderm cell number.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 32 years
- Sex
- Female only
- Age groups
- Adult
- Study population
- Patients who underwent ICSI with oocyte donation in IVI Vigo under time-lapse monitoring between 2013 and up to June 2019.
Key inclusion criteria (6 listed)
- Donors age < 32.
- IMC< 30kg/m2.
- Antral follicle count higher than 8.
- Single Blastocyst transference.
- 5% oxygen embryo culture,
Key exclusion criteria (5 listed)
- Müllerian anomalies,
- Hydrosalpinx.
- Any indication of oocyte vitrification.
- Severe male factor.
- Embryos transferences where a tenaculum was required, or more than one attempt was needed.
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 dataAlso: Collect retrospectively data on embryo implantation rate- Controlled ovarian stimulation with GnRH antagonists effected to the patients in order to get their eggs through follicular puncture, which will be trigger by GnRH analogue. The eggs will be isolated and processed according to the standard protocol. | Other | – |
Primary outcome
Researchers pretend to correlate the quality of the trophoectoderm and the embryo morphokinetics time with the hCG concentration after 13 days of embryo transfer, and also the implantation and the ongoing pregnancy rate.
Time frame: Since 2013 to april 2019
• Clinical pregnancy: when the maternal serum levels of β-hCG are higher than 10 UI/L, between 14 and 16 days after the fertilization and the presence of a gestational sac can be appreciated by ultrasound scan a week later (21-23 days after fertilization)
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 9 Feb 2021.
- Background: PubMed 24424365Basile N, Nogales Mdel C, Bronet F, Florensa M, Riqueiros M, Rodrigo L, Garcia-Velasco J, Meseguer M. Increasing the probability of selecting chromosomally normal embryos by time-lapse morphokinetics analysis. Fertil Steril. 2014 Mar;101(3):699-704. doi: 10.1016/j.fertnstert.2013.12.005. Epub 2014 Jan 11.
- 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.
- Individual participant dataSharing planned: No
Related trials for hCG
Not yet recruitingObservational study
Comparison of Beta-hCG Levels When Using Venous Puncture Blood and Peripheral Finger Stick Blood
Pregnancy
Not yet recruitingObservational study
Predicate and Lay User-HCP Comparison Study of a Multi-Level Urine hCG Pregnancy Test
Pregnancy
Not yet recruitingEarly Phase 1
hCG Treatment for Rehabilitation From a TBI
Traumatic Brain Injury
RecruitingObservational study
Machine-Learning Prediction of Pregnancy Outcomes After Assisted Reproductive Treatments
IVF Outcomes, Prediction Models
Recruiting
Dual Trigger VS HCG Trigger for Final Oocyte Maturation in Normal Responders
ICSI, IVF
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 hCG, 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 6 inclusion and 5 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 9 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?
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?
Researchers pretend to correlate the quality of the trophoectoderm and the embryo morphokinetics time with the hCG concentration after 13 days of embryo transfer, and also the implantation and the ongoing pregnancy rate. (time frame: Since 2013 to april 2019). 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 NCT04744519, which also lists 2 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 9 Feb 2021.