IVF OutcomesNCT07855783
Machine-Learning Prediction of Pregnancy Outcomes After Assisted Reproductive Treatments
An observational study of IVF Outcomes and Prediction Models, run by BetaPlus Center for Reproductive Medicine at 2 sites in Croatia.
Trial summary
The goal of this observational study is to develop and validate a machine-learning model to predict pregnancy outcomes in women with a positive pregnancy test following assisted reproductive treatment (ART), with the primary analysis focusing on in vitro fertilization (IVF) and frozen embryo transfer (FET). Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- IVF Outcomes, Prediction Models, Infertility Assisted Reproductive Technology
- What is being tested?
- Machine-Learning Model for Prediction of Pregnancy Outcomes
- How many people
- 2,200 participants
- Where
- 2 sitesCroatia
- Study dates
- 1 Jan 2026to 30 Sep 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 45 years
- Women only
- No healthy volunteers
- Adult
Study population: Participants will be women undergoing ART at the BetaPlus Center and, during the prospective validation phase, at the Clinical University Hospital in Rijeka, Croatia. The study population will include patients undergoing IVF/ICSI, FET, or IUI.
Who may be able to join
- Women who underwent ART procedures (IUI, IVF/ICSI, or FET) using homologous oocytes.
- Availability of at least one positive early serum beta-HCG measurement after aspiration, FET, or insemination (beta-HCG >10 mIU/mL).
- Availability of the pregnancy outcome.
- Availability of relevant patient characteristics and clinical variables required for predictive modeling.
- For embryo-transfer cycles, availability of information on embryo developmental stage and number of embryos transferred where applicable.
- For the prospective validation cohort, written informed consent.
Who cannot join
- Missing beta-HCG measurements critical for model input.
- Missing key demographic or clinical variables required for predictive modeling.
- Missing ART treatment protocol where required for the model.
- Missing pregnancy outcomes.
- Multiple pregnancy, hydatidiform mole, heterotopic pregnancy, and ectopic pregnancy will be excluded from the primary live-birth analysis but will be described separately and, where sample size permits, evaluated as secondary adverse pregnancy outcomes.
- Non-consent for prospective participation in validation.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Croatia2 sites, 2 recruiting
- Recruiting
Clinical Hospital Center
Rijeka
Neda Smiljan Severinski, +385913644239, nedass@medri.uniri.hr
- Recruiting
BetaPlus Center for Reproductive Medicine
Zagreb, 10000
Martina Kuzman, +385993765735, martina@betaplus.hr
About this study
Official title: Development and Validation of a Machine Learning Prognostic Model for Early Prediction of Pregnancy Outcomes Following Assisted Reproductive Treatment: A Retrospective and Prospective Cohort Study
The goal of this observational study is to develop and validate a machine-learning model to predict pregnancy outcomes in women with a positive pregnancy test following assisted reproductive treatment (ART), with the primary analysis focusing on in vitro fertilization (IVF) and frozen embryo transfer (FET). The study will also include an exploratory analysis of pregnancies following intrauterine insemination (IUI). The main questions addressed by the study are:
Can early blood levels of beta-human chorionic gonadotropin (beta-hCG) predict the likelihood of live birth in an IVF or FET cycle? Can early beta-hCG levels help identify pregnancies at increased risk of biochemical pregnancy or early pregnancy loss?
Participants will have clinical and treatment information, including beta-hCG measurements and pregnancy outcomes, collected from medical records or during prospective follow-up. No changes to participants' medical treatment will be made as part of the study.
Read the detailed description
Infertility affects more than 15% of the global population, and ART are increasingly used to achieve pregnancy. The field continues to evolve rapidly with ongoing technological and clinical advances. Although these advances have improved ART, success rates continue to vary, contributing to significant psychological distress among patients due to uncertainty regarding outcomes.
The most intense stress typically occurs after the procedure, especially following a positive pregnancy test and before ultrasound confirmation. This period, which lasts at least 3-4 weeks, is characterized by considerable uncertainty, as neither patients nor healthcare providers have reliable tools to determine pregnancy viability, assess early development, or accurately predict pregnancy progression. An individualized assessment of the probability of live birth after a positive pregnancy test could provide clinically meaningful information during this period and potentially improve counseling and management of patient expectations.
Serum beta-hCG is one of the earliest measurable biomarkers following embryo implantation and has long been recognized as an important prognostic marker of early pregnancy outcome. Both the absolute concentration of beta-HCG and its subsequent rate of increase have been associated with pregnancy viability and live birth following embryo transfer.
Investigators plan to use a machine-learning system to collect and analyze retrospective clinical data. Beta-HCG values from this dataset were collected at very early stages of pregnancy (around aspiration days +14 and 16, and post-FET days 9 and 11).
Patients were advised to have blood drawn for beta-HCG measurement 14 days after oocyte aspiration or insemination, followed by a second measurement two days later. For FET, measurements were taken 9 days after blastocyst transfer (or the corresponding day for cleavage-stage embryos) and two days afterward. Due to scheduling constraints, such as weekends, actual measurements may have occurred one day earlier or later, or several days apart. The dataset included the exact dates of each blood draw, allowing precise calculation of the interval between measurements for analysis.
ART outcomes were primarily collected through direct patient reporting of events, including adverse pregnancy outcomes or live birth; for patients who did not report the outcomes, clinic staff conducted follow-up calls to ensure complete follow-up.
This study is an observational retrospective-prospective cohort study for development and validation of an AI (artificial intelligence) - based prognostic model predicting live birth after ART.
The retrospective phase will use existing clinical data from patients who underwent ART procedures at the BetaPlus Center between January 2017 and 31.12.2025.
The prospective phase will include consecutive patients undergoing ART after model development in both BetaPlus Center and Clinical University Hospital in Rijeka. These patients will be followed to assess pregnancy outcomes, enabling external validation of the model.
The study is observational in nature. No interventions, treatment modifications, or randomization will be performed as part of this research. Clinical management will follow standard operating procedures (SOP) independent of model predictions.
- Being tested
- Machine-Learning Model for Prediction of Pregnancy Outcomes
- Keywords
- Prediction model, Machine learning, Biochemical pregnancy, Early pregnancy loss, Pregnancy outcome, Beta-hCG, Assisted reproductive technology
- Medical subject headings
- Abortion, Spontaneous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Machine-Learning Model for Prediction of Pregnancy OutcomesOther
A machine-learning prognostic model using early serum beta-hCG measurements and patient, embryo, and treatment characteristics to predict live birth and early adverse pregnancy outcomes following assisted reproductive treatment.
| Study group | Role | What they receive |
|---|---|---|
| ART pregnancies with positive beta-hCG | Patients with a positive serum beta-hCG measurement following ART, including IVF, FET, and IUI. Participants will be followed to assess pregnancy outcomes, including live birth, biochemical pregnancy, and early pregnancy loss. Receives: Other: Machine-Learning Model for Prediction of Pregnancy Outcomes |
What is being measured
The primary outcome is the main question the study is designed to answer.
Live birth following ART
Delivery of a live infant at ≥24 weeks of gestation.
Measured: From positive pregnancy test until delivery.
Secondary outcomes (2)
Biochemical pregnancy following ART
A pregnancy characterized by a positive serum beta-hCG test followed by bleeding or pregnancy loss without ultrasound confirmation of a clinical pregnancy.
Measured: From the first positive serum beta-hCG measurement until biochemical pregnancy resolution.
Early Pregnancy Loss following ART
Pregnancy loss occurring before 12 weeks of gestation, excluding biochemical pregnancy, ectopic pregnancy, heterotopic pregnancy, and hydatidiform mole.
Measured: From clinical pregnancy confirmation until 12 weeks of gestation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2026
- Study start1 Jan 2026
- Primary completion31 Dec 2026 (estimated)
- Study completion30 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for IVF OutcomesStudies 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
- Other
- Enrolment
- 2,200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- BetaPlus Center for Reproductive Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Clinical Hospital Center Rijeka
- Responsible party
- Sponsor
- Investigators
- Romana Dmitrovic, Principal investigator, BetaPlus Center for Reproductive Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07855783
- Sponsor's protocol ID
- PK 1.1.12.0074
- Other IDs
- PK 1.1.12.0074
- Status last verified
- Oct 2026
- First submitted
- 28 Sep 2026
- Last updated
- 7 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data underlying the results of this study will be made available upon reasonable request. The shared dataset will include the clinical and treatment variables necessary to reproduce or further investigate the study findings, including relevant beta-hCG measurements, timing of measurements, ART treatment characteristics, and pregnancy outcomes. Data will not include names, contact information, medical record numbers, or other directly identifying information.
Publications
Clarke EA, Jones C, Reckhow J, Flannagan K, Shaari D, Baird M, Lee JA, Sekhon L, Copperman AB, Romanski PA. Prognostic utility of serum beta human chorionic gonadotropin level following single euploid embryo transfer for live birth. Fertil Steril. 2026 Aug;126(2):371-378. doi: 10.1016/j.fertnstert.2026.04.025. Epub 2026 May 4.
PubMed 42092529Papageorgiou TC, Leondires MP, Miller BT, Chang AS, Armstrong AB, Scott LA, Segars JH. Human chorionic gonadotropin levels after blastocyst transfer are highly predictive of pregnancy outcome. Fertil Steril. 2001 Nov;76(5):981-7. doi: 10.1016/s0015-0282(01)02840-0.
PubMed 11704121Mourad A, Antaki R, Rowen M, Levesque E, Lapensee L. The POPI-Plus tool: prediction model of outcome of pregnancy in in vitro fertilization from a large retrospective cohort. Fertil Steril. 2024 Mar;121(3):489-496. doi: 10.1016/j.fertnstert.2023.11.035. Epub 2023 Dec 1.
PubMed 38043845Kidera N, Ishikawa T, Kawamura T, Miyasaka N. Serum human chorionic gonadotropin can predict live birth 7 days after frozen-thawed blastocyst transfer. F S Rep. 2025 Oct 23;6(4):455-461. doi: 10.1016/j.xfre.2025.10.002. eCollection 2025 Dec.
PubMed 41473560Kalafat E, Ata B, Del Gallego R, Freedman A, Hoyos LR, Elkhatib I, Miller KA, Fatemi H, Lawrenz B. Predicting live birth following single euploid frozen-embryo transfer via beta-hCG dynamics: iHOPE prognostic model with external validation. Ultrasound Obstet Gynecol. 2026 Jun;67(6):824-835. doi: 10.1002/uog.70238. Epub 2026 May 24.
PubMed 42177810Schmidt LL, Asch RH, Frederick JL, Rojas FJ, Stone SC, Balmaceda JP. The predictive value of a single beta human chorionic gonadotropin in pregnancies achieved by assisted reproductive technology. Fertil Steril. 1994 Aug;62(2):333-8. doi: 10.1016/s0015-0282(16)56887-3.
PubMed 8034081Hughes LM, Schuler A, Sharmuk M, Schauer JM, Pavone ME, Bernardi LA. Early beta-hCG levels predict live birth after single embryo transfer. J Assist Reprod Genet. 2022 Oct;39(10):2355-2364. doi: 10.1007/s10815-022-02606-w. Epub 2022 Sep 8.
PubMed 36074224Trautner PS, Oppelt P, Resch S, Enzelsberger SH, Ebner T, Shebl OJ. Single day 14 serum hCG values allow prediction of viable pregnancy and are significantly higher in frozen as compared to fresh single blastocyst transfer. J Assist Reprod Genet. 2024 Aug;41(8):2193-2200. doi: 10.1007/s10815-024-03164-z. Epub 2024 Jun 13.
PubMed 38867095Al Mamari N, Al Zawawi N, Khayat S, Badeghiesh A, Son WY, Dahan MH. Revisiting serum beta-hCG cut-off levels and pregnancy outcomes using single embryo transfer. J Assist Reprod Genet. 2019 Nov;36(11):2307-2313. doi: 10.1007/s10815-019-01583-x. Epub 2019 Oct 12.
PubMed 31605261Sarret Y, Reano A, Nicolas JF, Su H, Thivolet J. Bullous pemphigoid and cicatricial pemphigoid: immunoblotting detection of involved autoantigens. Autoimmunity. 1989;2(2):145-53. doi: 10.3109/08916938909019951.
PubMed 2491598Hobeika E, Singh S, Malik S, Knochenhauer ES, Traub ML. Initial maternal serum human chorionic gonadotropin levels in pregnancies achieved after assisted reproductive technology are higher after preimplantation genetic screening and after frozen embryo transfer: a retrospective cohort. J Assist Reprod Genet. 2017 Oct;34(10):1333-1340. doi: 10.1007/s10815-017-0987-2. Epub 2017 Jun 21.
PubMed 28639180Kathiresan AS, Cruz-Almeida Y, Barrionuevo MJ, Maxson WS, Hoffman DI, Weitzman VN, Christie DR, Manko GF, Ory SJ. Prognostic value of beta-human chorionic gonadotropin is dependent on day of embryo transfer during in vitro fertilization. Fertil Steril. 2011 Dec;96(6):1362-6. doi: 10.1016/j.fertnstert.2011.09.042. Epub 2011 Nov 1.
PubMed 22047663Oron G, Shavit T, Esh-Broder E, Weon-Young S, Tulandi T, Holzer H. Predictive value of serum HCG concentrations in pregnancies achieved after single fresh or vitrified-warmed blastocyst transfer. Reprod Biomed Online. 2017 Sep;35(3):272-278. doi: 10.1016/j.rbmo.2017.05.011. Epub 2017 May 30.
PubMed 28625759Oron G, Esh-Broder E, Son WY, Holzer H, Tulandi T. Predictive value of maternal serum human chorionic gonadotropin levels in pregnancies achieved by in vitro fertilization with single cleavage and single blastocyst embryo transfers. Fertil Steril. 2015 Jun;103(6):1526-31.e1-2. doi: 10.1016/j.fertnstert.2015.02.028. Epub 2015 Apr 22.
PubMed 25910571Ozer G. Initial beta-hCG levels and 2-day-later increase rates effectively predict pregnancy outcomes in single blastocyst transfer in frozen-thawed or fresh cycles: A retrospective cohort study. Medicine (Baltimore). 2023 Oct 20;102(42):e35605. doi: 10.1097/MD.0000000000035605.
PubMed 37861533
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Validation of a Machine Learning Prognostic Model for Early Prediction of Pregnancy Outcomes Following Assisted Reproductive Treatment: A Retrospective and Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT07855783
- Acronym / sponsor ID
- PK 1.1.12.0074
- Keywords
- Prediction model, Machine learning, Biochemical pregnancy, Early pregnancy loss, Pregnancy outcome, Beta-hCG, Assisted reproductive technology
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 2,200 participants (estimated)
- Lead sponsor
- BetaPlus Center for Reproductive MedicineUniversity, hospital or other
- Collaborators
- Clinical Hospital Center Rijeka
- Study start
- 1 Jan 2026 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 30 Sep 2027 (estimated)
- First posted
- 2 Oct 2026 (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 goal of this observational study is to develop and validate a machine-learning model to predict pregnancy outcomes in women with a positive pregnancy test following assisted reproductive treatment (ART), with the primary analysis focusing on in vitro fertilization (IVF) and frozen embryo transfer (FET). The study will also include an exploratory analysis of pregnancies following intrauterine insemination (IUI). The main questions addressed by the study are:
Can early blood levels of beta-human chorionic gonadotropin (beta-hCG) predict the likelihood of live birth in an IVF or FET cycle? Can early beta-hCG levels help identify pregnancies at increased risk of biochemical pregnancy or early pregnancy loss?
Participants will have clinical and treatment information, including beta-hCG measurements and pregnancy outcomes, collected from medical records or during prospective follow-up. No changes to participants' medical treatment will be made as part of the study.
Detailed description
Infertility affects more than 15% of the global population, and ART are increasingly used to achieve pregnancy. The field continues to evolve rapidly with ongoing technological and clinical advances. Although these advances have improved ART, success rates continue to vary, contributing to significant psychological distress among patients due to uncertainty regarding outcomes.
The most intense stress typically occurs after the procedure, especially following a positive pregnancy test and before ultrasound confirmation. This period, which lasts at least 3-4 weeks, is characterized by considerable uncertainty, as neither patients nor healthcare providers have reliable tools to determine pregnancy viability, assess early development, or accurately predict pregnancy progression. An individualized assessment of the probability of live birth after a positive pregnancy test could provide clinically meaningful information during this period and potentially improve counseling and management of patient expectations.
Serum beta-hCG is one of the earliest measurable biomarkers following embryo implantation and has long been recognized as an important prognostic marker of early pregnancy outcome. Both the absolute concentration of beta-HCG and its subsequent rate of increase have been associated with pregnancy viability and live birth following embryo transfer.
Investigators plan to use a machine-learning system to collect and analyze retrospective clinical data. Beta-HCG values from this dataset were collected at very early stages of pregnancy (around aspiration days +14 and 16, and post-FET days 9 and 11).
Patients were advised to have blood drawn for beta-HCG measurement 14 days after oocyte aspiration or insemination, followed by a second measurement two days later. For FET, measurements were taken 9 days after blastocyst transfer (or the corresponding day for cleavage-stage embryos) and two days afterward. Due to scheduling constraints, such as weekends, actual measurements may have occurred one day earlier or later, or several days apart. The dataset included the exact dates of each blood draw, allowing precise calculation of the interval between measurements for analysis.
ART outcomes were primarily collected through direct patient reporting of events, including adverse pregnancy outcomes or live birth; for patients who did not report the outcomes, clinic staff conducted follow-up calls to ensure complete follow-up.
This study is an observational retrospective-prospective cohort study for development and validation of an AI (artificial intelligence) - based prognostic model predicting live birth after ART.
The retrospective phase will use existing clinical data from patients who underwent ART procedures at the BetaPlus Center between January 2017 and 31.12.2025.
The prospective phase will include consecutive patients undergoing ART after model development in both BetaPlus Center and Clinical University Hospital in Rijeka. These patients will be followed to assess pregnancy outcomes, enabling external validation of the model.
The study is observational in nature. No interventions, treatment modifications, or randomization will be performed as part of this research. Clinical management will follow standard operating procedures (SOP) independent of model predictions.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ART pregnancies with positive beta-hCG | – | Other: Machine-Learning Model for Prediction of Pregnancy OutcomesPatients with a positive serum beta-hCG measurement following ART, including IVF, FET, and IUI. Participants will be followed to assess pregnancy outcomes, including live birth, biochemical pregnancy, and early pregnancy loss. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Participants will be women undergoing ART at the BetaPlus Center and, during the prospective validation phase, at the Clinical University Hospital in Rijeka, Croatia. The study population will include patients undergoing IVF/ICSI, FET, or IUI.
Key inclusion criteria (6 listed)
- Women who underwent ART procedures (IUI, IVF/ICSI, or FET) using homologous oocytes.
- Availability of at least one positive early serum beta-HCG measurement after aspiration, FET, or insemination (beta-HCG >10 mIU/mL).
- Availability of the pregnancy outcome.
- Availability of relevant patient characteristics and clinical variables required for predictive modeling.
- For embryo-transfer cycles, availability of information on embryo developmental stage and number of embryos transferred where applicable.
Key exclusion criteria (6 listed)
- Missing beta-HCG measurements critical for model input.
- Missing key demographic or clinical variables required for predictive modeling.
- Missing ART treatment protocol where required for the model.
- Missing pregnancy outcomes.
- Multiple pregnancy, hydatidiform mole, heterotopic pregnancy, and ectopic pregnancy will be excluded from the primary live-birth analysis but will be described separately and, where sample size permits, evaluated as secondary adverse pregnancy outcomes.
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 |
|---|---|---|
| Machine-Learning Model for Prediction of Pregnancy OutcomesA machine-learning prognostic model using early serum beta-hCG measurements and patient, embryo, and treatment characteristics to predict live birth and early adverse pregnancy outcomes following assisted reproductive treatment. | Other | ART pregnancies with positive beta-hCG |
Primary outcome
Live birth following ART
Time frame: From positive pregnancy test until delivery.
Delivery of a live infant at ≥24 weeks of gestation.
2 secondary outcomes
Biochemical pregnancy following ART
Time frame: From the first positive serum beta-hCG measurement until biochemical pregnancy resolution.
Early Pregnancy Loss following ART
Time frame: From clinical pregnancy confirmation until 12 weeks of gestation.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2026.
- Background: PubMed 42092529Clarke EA, Jones C, Reckhow J, Flannagan K, Shaari D, Baird M, Lee JA, Sekhon L, Copperman AB, Romanski PA. Prognostic utility of serum beta human chorionic gonadotropin level following single euploid embryo transfer for live birth. Fertil Steril. 2026 Aug;126(2):371-378. doi: 10.1016/j.fertnstert.2026.04.025. Epub 2026 May 4.
- Background: PubMed 11704121Papageorgiou TC, Leondires MP, Miller BT, Chang AS, Armstrong AB, Scott LA, Segars JH. Human chorionic gonadotropin levels after blastocyst transfer are highly predictive of pregnancy outcome. Fertil Steril. 2001 Nov;76(5):981-7. doi: 10.1016/s0015-0282(01)02840-0.
- Background: PubMed 38043845Mourad A, Antaki R, Rowen M, Levesque E, Lapensee L. The POPI-Plus tool: prediction model of outcome of pregnancy in in vitro fertilization from a large retrospective cohort. Fertil Steril. 2024 Mar;121(3):489-496. doi: 10.1016/j.fertnstert.2023.11.035. Epub 2023 Dec 1.
- Background: PubMed 41473560Kidera N, Ishikawa T, Kawamura T, Miyasaka N. Serum human chorionic gonadotropin can predict live birth 7 days after frozen-thawed blastocyst transfer. F S Rep. 2025 Oct 23;6(4):455-461. doi: 10.1016/j.xfre.2025.10.002. eCollection 2025 Dec.
- Background: PubMed 42177810Kalafat E, Ata B, Del Gallego R, Freedman A, Hoyos LR, Elkhatib I, Miller KA, Fatemi H, Lawrenz B. Predicting live birth following single euploid frozen-embryo transfer via beta-hCG dynamics: iHOPE prognostic model with external validation. Ultrasound Obstet Gynecol. 2026 Jun;67(6):824-835. doi: 10.1002/uog.70238. Epub 2026 May 24.
- Background: PubMed 8034081Schmidt LL, Asch RH, Frederick JL, Rojas FJ, Stone SC, Balmaceda JP. The predictive value of a single beta human chorionic gonadotropin in pregnancies achieved by assisted reproductive technology. Fertil Steril. 1994 Aug;62(2):333-8. doi: 10.1016/s0015-0282(16)56887-3.
- Background: PubMed 36074224Hughes LM, Schuler A, Sharmuk M, Schauer JM, Pavone ME, Bernardi LA. Early beta-hCG levels predict live birth after single embryo transfer. J Assist Reprod Genet. 2022 Oct;39(10):2355-2364. doi: 10.1007/s10815-022-02606-w. Epub 2022 Sep 8.
- Background: PubMed 38867095Trautner PS, Oppelt P, Resch S, Enzelsberger SH, Ebner T, Shebl OJ. Single day 14 serum hCG values allow prediction of viable pregnancy and are significantly higher in frozen as compared to fresh single blastocyst transfer. J Assist Reprod Genet. 2024 Aug;41(8):2193-2200. doi: 10.1007/s10815-024-03164-z. Epub 2024 Jun 13.
- Background: PubMed 31605261Al Mamari N, Al Zawawi N, Khayat S, Badeghiesh A, Son WY, Dahan MH. Revisiting serum beta-hCG cut-off levels and pregnancy outcomes using single embryo transfer. J Assist Reprod Genet. 2019 Nov;36(11):2307-2313. doi: 10.1007/s10815-019-01583-x. Epub 2019 Oct 12.
- Background: PubMed 2491598Sarret Y, Reano A, Nicolas JF, Su H, Thivolet J. Bullous pemphigoid and cicatricial pemphigoid: immunoblotting detection of involved autoantigens. Autoimmunity. 1989;2(2):145-53. doi: 10.3109/08916938909019951.
- Background: PubMed 28639180Hobeika E, Singh S, Malik S, Knochenhauer ES, Traub ML. Initial maternal serum human chorionic gonadotropin levels in pregnancies achieved after assisted reproductive technology are higher after preimplantation genetic screening and after frozen embryo transfer: a retrospective cohort. J Assist Reprod Genet. 2017 Oct;34(10):1333-1340. doi: 10.1007/s10815-017-0987-2. Epub 2017 Jun 21.
- Background: PubMed 22047663Kathiresan AS, Cruz-Almeida Y, Barrionuevo MJ, Maxson WS, Hoffman DI, Weitzman VN, Christie DR, Manko GF, Ory SJ. Prognostic value of beta-human chorionic gonadotropin is dependent on day of embryo transfer during in vitro fertilization. Fertil Steril. 2011 Dec;96(6):1362-6. doi: 10.1016/j.fertnstert.2011.09.042. Epub 2011 Nov 1.
- Individual participant dataSharing planned: Yes. De-identified individual participant data underlying the results of this study will be made available upon reasonable request. The shared dataset will include the clinical and treatment variables necessary to reproduce or further investigate the study findings, including relevant beta-hCG measurements, timing of measurements, ART treatment characteristics, and pregnancy outcomes. Data will not include names, contact information, medical record numbers, or other directly identifying information.
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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.
Romana Dmitrovic principal investigator
BetaPlus Center for Reproductive Medicine
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 IVF Outcomes and Prediction Models, run by BetaPlus Center for Reproductive Medicine at 2 sites in Croatia.
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 6 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: looking for participants now, as of the sponsor's last update on 7 Oct 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 Croatia. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Romana Dmitrovic (+385981983563, romana@betaplus.hr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Live birth following ART (time frame: From positive pregnancy test until delivery.). 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 NCT07855783, which also lists 15 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 7 Oct 2026.