Pregnancy Loss, EarlyBPLNCT04549909
Biochemical Pregnancy Loss. A Multicenter Retrospective Study
An observational study of Pregnancy Loss, Early, run by IVI Vigo at 1 site in Spain.
Trial summary
Biochemical pregnancy loss (BPL) is a very frequent issue in human reproduction. After the implantation of the embryo, hCG disappears very soon from the maternal bloodstream and no evidence of a clinical pregnancy is seen. Read more about this study
- Who is it for?
- Ages 18 to 44 years, women only
- Conditions the study is for
- Pregnancy Loss, Early
- What is being tested?
- collect retrospectively data
- How many people
- 20,000 participants
- Where
- 1 siteSpain
- Study dates
- 12 Feb 2019to 15 Jan 2020
- 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 44 years
- Women only
- No healthy volunteers
- Adult
Study population: Infertile patients who come to participating centres for assisted reproduction treatments. Patients will be divided into 4 groups according to the treatment carried out: PGT-A, ERA, FET from own oocytes (CO) or FET from donated oocytes (CD).
Who may be able to join
- Patients with the following selection criteria:
- IVF/ICSI patients aged between 18 and 44
- BMI 18-30 kg/m2
- Frozen embryo transfer from own oocytes after PGT-A
- Frozen embryo transfer with ERA test (from own or donated oocytes)
- Frozen embryo transfer (from own or donated oocytes)
Show all 14Show fewer
- Single embryo transfer (SET) in all cycles
- Patients without uterine malformations
- Patients without recurrent miscarriage (≥ 3)
- Patients with adequate endometrial thickness (> 7mm)
- Patients without thyroid autoimmunity
- Patients without thrombophilia
- Exclude cycles with exclusively PGT-M
- Exclude FET in ovarian stimulated cycles
Who cannot join
- Exclude cycles with exclusively PGT-M Exclude FET in ovarian stimulated cycles
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Is Biochemical Pregnancy Loss Associated to Embryo or Endometrium? A Multicenter Retrospective Study
Biochemical pregnancy loss (BPL) is a very frequent issue in human reproduction. After the implantation of the embryo, hCG disappears very soon from the maternal bloodstream and no evidence of a clinical pregnancy is seen. Different studies showed that factors such as age, oocyte and embryo quality, and endometrium receptivity may have something to do with the occurrence of biochemical pregnancy loss post assisted reproduction treatment.
The main aim of this study is to evaluate the incidence of biochemical pregnancy loss (BPL) in three different cohort populations; patients undergoing frozen embryo transfer (FET) from own oocytes after preimplantation genetic testing for aneuploidy (PGT-A), patients undergoing FET from own and donated oocytes and with endometrial receptivity array (ERA), and patients undergoing FET from own or donated oocytes (without PGTA or ERA test).
We will analyse the incidence of BPL in these populations and try to determine the role of the euploid status embryo in the first group, the endometrium in the second group and the third one as control group. We are waiting to find the value of both players in the origin of BPL.
Read the detailed description
Human embryo implantation is a poorly understood process. Once the embryo implants in the endometrium, it starts to secrete hCG that can be measured in the maternal blood as early as 9 days after implantation. Only a minimal number of pregnancies get to newborn, and the majority are lost before reach the first trimester (Larsen et al., 2013).
We are looking for the role of the embryo after controlling its chromosomal ploidy, and the endometrium after controlling its transcriptomic expression. We will also use a no exposed group to the controlled euploid embryo factor neither endometrial factor that is the oocyte donation group. This analysis expects to provide more information about the key role of embryo or endometrium in BPL.
- Conditions
- Pregnancy Loss, Early
- Being tested
- collect retrospectively data
- Keywords
- pregnancy, abortion, bioquemical
- Medical subject headings
- Abortion, Spontaneous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
collect retrospectively dataOther
Analyse the incidence of BPL in these populations
| Study group | Role | What they receive |
|---|---|---|
| preimplantation genetic testing for aneuploidy (PGT-A) Group | Patients who have undergone preimplantation genetic testing for aneuploidy (PGT-A) (transfer of own frozen embryo) Receives: Other: collect retrospectively data | |
| endometrial receptivity array (ERA) Group | Patients who have undergone frozen embryo transfer (FET) with endometrial receptivity array (ERA) test (embryos from own or donated oocytes) Receives: Other: collect retrospectively data | |
| CONTROL OWN (CO) Group | Control group of FET from own oocytes (without ERA or PGT-A) Receives: Other: collect retrospectively data | |
| CONTROL DONATED(CD) Group | Control group of FET from donated oocytes (without ERA or PGT-A) Receives: Other: collect retrospectively data |
What is being measured
The primary outcome is the main question the study is designed to answer.
Biochemical pregnancy loss (BPL)
when the maternal serum levels of β-hCG are higher than 10 UI/L, but in the transvaginal ultrasound is not possible to appreciate any gestational structure (dichotomous qualitative variable: yes/no). This variable is considered as the fraction between patients whose β-hCG is higher than 10 UI/L, without clinically recognized pregnancy, by number of pregnant patients.
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 posted16 Sep 2020
- Study start12 Feb 2019
- Primary completion15 Jan 2020
- Study completion15 Jan 2020
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 Pregnancy Loss, EarlyStudies 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
- 20,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- IVI Vigo
- Sponsor type
- University, hospital or other
- Collaborators
- Instituto Valenciano de Infertilidad, IVI VALENCIA, IVI Madrid, Fundación IVI
- Responsible party
- Sponsor
- Investigators
- Elkin DR Muñoz, MD, Principal investigator, IVI Vigo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04549909
- Sponsor's protocol ID
- 1902-VGO-019-EM
- Acronym
- BPL
- Status last verified
- Sep 2020
- First submitted
- 9 Sep 2020
- Last updated
- 23 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Diaz-Gimeno P, Horcajadas JA, Martinez-Conejero JA, Esteban FJ, Alama P, Pellicer A, Simon C. A genomic diagnostic tool for human endometrial receptivity based on the transcriptomic signature. Fertil Steril. 2011 Jan;95(1):50-60, 60.e1-15. doi: 10.1016/j.fertnstert.2010.04.063. Epub 2010 Jul 8.
PubMed 20619403Munoz E, Taboas E, Alvarez M, Gil E, Perez A, Portela S, Martinez-Chapela M, Saucedo E, Garrido N. Is biochemical pregnancy loss associated with embryo or endometrium? A retrospective cohort study in frozen single embryo transfer of own and donated oocytes. Hum Reprod. 2024 May 22:deae106. doi: 10.1093/humrep/deae106. Online ahead of print.
PubMed 38775331
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is Biochemical Pregnancy Loss Associated to Embryo or Endometrium? A Multicenter Retrospective Study
- ClinicalTrials.gov ID
- NCT04549909
- Acronym / sponsor ID
- BPL / 1902-VGO-019-EM
- Conditions
- Pregnancy Loss, Early
- Keywords
- pregnancy, abortion, bioquemical
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20,000 participants (actual)
- Lead sponsor
- IVI VigoUniversity, hospital or other
- Collaborators
- Instituto Valenciano de Infertilidad, IVI VALENCIA, IVI Madrid, Fundación IVI
- Study start
- 12 Feb 2019 (actual)
- Primary completion
- 15 Jan 2020 (actual)
- Study completion
- 15 Jan 2020 (actual)
- First posted
- 16 Sep 2020 (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.
Biochemical pregnancy loss (BPL) is a very frequent issue in human reproduction. After the implantation of the embryo, hCG disappears very soon from the maternal bloodstream and no evidence of a clinical pregnancy is seen. Different studies showed that factors such as age, oocyte and embryo quality, and endometrium receptivity may have something to do with the occurrence of biochemical pregnancy loss post assisted reproduction treatment.
The main aim of this study is to evaluate the incidence of biochemical pregnancy loss (BPL) in three different cohort populations; patients undergoing frozen embryo transfer (FET) from own oocytes after preimplantation genetic testing for aneuploidy (PGT-A), patients undergoing FET from own and donated oocytes and with endometrial receptivity array (ERA), and patients undergoing FET from own or donated oocytes (without PGTA or ERA test).
We will analyse the incidence of BPL in these populations and try to determine the role of the euploid status embryo in the first group, the endometrium in the second group and the third one as control group. We are waiting to find the value of both players in the origin of BPL.
Detailed description
Human embryo implantation is a poorly understood process. Once the embryo implants in the endometrium, it starts to secrete hCG that can be measured in the maternal blood as early as 9 days after implantation. Only a minimal number of pregnancies get to newborn, and the majority are lost before reach the first trimester (Larsen et al., 2013).
We are looking for the role of the embryo after controlling its chromosomal ploidy, and the endometrium after controlling its transcriptomic expression. We will also use a no exposed group to the controlled euploid embryo factor neither endometrial factor that is the oocyte donation group. This analysis expects to provide more information about the key role of embryo or endometrium in BPL.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| preimplantation genetic testing for aneuploidy (PGT-A) Group | – | Other: collect retrospectively dataPatients who have undergone preimplantation genetic testing for aneuploidy (PGT-A) (transfer of own frozen embryo) |
| endometrial receptivity array (ERA) Group | – | Other: collect retrospectively dataPatients who have undergone frozen embryo transfer (FET) with endometrial receptivity array (ERA) test (embryos from own or donated oocytes) |
| CONTROL OWN (CO) Group | – | Other: collect retrospectively dataControl group of FET from own oocytes (without ERA or PGT-A) |
| CONTROL DONATED(CD) Group | – | Other: collect retrospectively dataControl group of FET from donated oocytes (without ERA or PGT-A) |
Who may qualify
- Ages
- 18 to 44 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Infertile patients who come to participating centres for assisted reproduction treatments. Patients will be divided into 4 groups according to the treatment carried out: PGT-A, ERA, FET from own oocytes (CO) or FET from donated oocytes (CD).
Key inclusion criteria (14 listed)
- IVF/ICSI patients aged between 18 and 44
- BMI 18-30 kg/m2
- Frozen embryo transfer from own oocytes after PGT-A
- Frozen embryo transfer with ERA test (from own or donated oocytes)
- Frozen embryo transfer (from own or donated oocytes)
Key exclusion criteria (2 listed)
- Exclude cycles with exclusively PGT-M Exclude FET in ovarian stimulated cycles
- -
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 retrospectively dataAnalyse the incidence of BPL in these populations | Other | CONTROL DONATED(CD) Group, CONTROL OWN (CO) Group, endometrial receptivity array (ERA) Group, preimplantation genetic testing for aneuploidy (PGT-A) Group |
Primary outcome
Biochemical pregnancy loss (BPL)
Time frame: Since 2013 to april 2019
when the maternal serum levels of β-hCG are higher than 10 UI/L, but in the transvaginal ultrasound is not possible to appreciate any gestational structure (dichotomous qualitative variable: yes/no). This variable is considered as the fraction between patients whose β-hCG is higher than 10 UI/L, without clinically recognized pregnancy, by number of pregnant patients.
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 23 Sep 2020.
- Results publication: PubMed 20619403Diaz-Gimeno P, Horcajadas JA, Martinez-Conejero JA, Esteban FJ, Alama P, Pellicer A, Simon C. A genomic diagnostic tool for human endometrial receptivity based on the transcriptomic signature. Fertil Steril. 2011 Jan;95(1):50-60, 60.e1-15. doi: 10.1016/j.fertnstert.2010.04.063. Epub 2010 Jul 8.
- Derived from this study: PubMed 38775331Munoz E, Taboas E, Alvarez M, Gil E, Perez A, Portela S, Martinez-Chapela M, Saucedo E, Garrido N. Is biochemical pregnancy loss associated with embryo or endometrium? A retrospective cohort study in frozen single embryo transfer of own and donated oocytes. Hum Reprod. 2024 May 22:deae106. doi: 10.1093/humrep/deae106. Online ahead of print.
- 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 DR Muñoz, MD principal investigator
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 Pregnancy Loss, Early, 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 14 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 23 Sep 2020. 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?
Biochemical pregnancy loss (BPL) (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 NCT04549909, 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 23 Sep 2020.