Infertility Assisted Reproductive TechnologyFromSichNCT07458165
From a Single Child to Family Planning
An observational study of Infertility Assisted Reproductive Technology, run by Istituto Clinico Humanitas.
Trial summary
This monocentric retrospective cohort study aims to investigate reproductive behavior and subsequent family-building outcomes in couples who achieved a first live birth through assisted reproductive technology (ART) at a university-affiliated fertility center in Italy. Read more about this study
- Who is it for?
- Ages 18 to 43 years
- Conditions the study is for
- Infertility Assisted Reproductive Technology
- How many people
- 5,852 participants
- Where
- No sites listed yet
- Study dates
- Jan 2010to 31 Dec 2024
- 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 43 years
- All sexes
- No healthy volunteers
- Adult
Study population: The study included all couples who underwent and completed ART cycles and achieved a first live birth between January 2010 and December 2020, who subsequently returned for new attempts, and met the following inclusion criteria: being a heterosexual couple with maternal age between 18 and 43 years, having complete clinical and demographic data available in the internal database, and having follow-up information up to December 2024
Who may be able to join
- Copules underwent ART treatment at the Humanitas Fertility Center (Rozzano, Milan)
- Copules achieved a first clinical pregnancy resulting from ART between January 2010 and December 2020
- heterosexual couples in which the maternal age was between 18 and 43 years old
Who cannot join
- Couples who did not meet the inclusion criteria
- ART cycles involving preimplantation genetic testing for aneuploidy (PGT-A)
- Use of donor gametes (oocyte or sperm donation)
About this study
Official title: From Single Child to Family Planning: Determinants of Returning to ART to Build the Desired Family in a Monocentric Italian Cohort.
This monocentric retrospective cohort study aims to investigate reproductive behavior and subsequent family-building outcomes in couples who achieved a first live birth through assisted reproductive technology (ART) at a university-affiliated fertility center in Italy. All couples obtaining a first live birth between January 2010 and December 2020 will be included and followed until December 2024. The primary objective is to evaluate the rate of return for further ART treatment after the first live birth. Secondary objectives include assessing cumulative live birth rate (CLBR) for the second and third live birth. Associations between return behavior and clinical factors, including maternal age, presence of cryopreserved oocytes or embryos, and treatment characteristics, will be analyzed.
- Keywords
- return rate, cryopreservation, family building
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Non-returners | Couples who achieved a first live birth through ART at the study center and did not return for further ART treatment after the index birth during the follow-up period. | |
| Returners | Couples who achieved a first live birth through ART at the study center and subsequently returned to undergo one or more additional ART cycles for further reproductive attempts during follow-up. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Return rate of couples who had achieved a first pregnancy and returned to pursue a second child.
Analysis of the return rate of couples who had already achieved a first pregnancy and pursued a second child, with a comprehensive evaluation of the clinical, demographic, and treatment-related factors that may influence their likelihood of returning for additional ART attempts. This analysis aims to identify which characteristics are associated with a higher or lower probability of continuing their family-building journey after the initial live birth.
Measured: From January 2010 to December 2024
Secondary outcomes (1)
Cumulative live birth rate of couples who had already achieved a first live birth and attempted to conceive a second child
Analysis of the cumulative live birth rate of couples who had already achieved a first live birth and pursued a second child through subsequent ART attempts, with a comprehensive evaluation of the clinical, demographic, and treatment-related factors that may influence their probability of achieving an additional live birth. This analysis aims to identify which characteristics are associated with higher or lower chances of successfully obtaining a second live birth after the initial one
Measured: From January 2010 to December 2024
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2026
- Study startJan 2010
- Primary completion31 Dec 2024
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Infertility Assisted Reproductive TechnologyStudies of the same condition, open and under way.
- More trials run by Istituto Clinico HumanitasThe sponsor's other registered studies.
- 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
- 5,852 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istituto Clinico Humanitas
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michele Tedeschi, Istituto Clinico Humanitas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07458165
- Sponsor's protocol ID
- GIN2/OSS001/2025
- Other IDs
- Ethics committee No. 4773
- Acronym
- FromSich
- Status last verified
- Mar 2026
- First submitted
- 3 Mar 2026
- Last updated
- 10 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared due to the retrospective design of the study and institutional data protection policies. Only aggregated, anonymized results will be made available in the published manuscript.
Publications
Viciglione F, Immediata V, Morenghi E, Alviggi C, Baggiani A, Cirillo F, Levi-Setti PE. From a single child to family planning: determinants of returning to ART to build the desired family in a monocentric Italian cohort. Hum Reprod Open. 2026 Jul 21;2026(3):hoag063. doi: 10.1093/hropen/hoag063. eCollection 2026.
PubMed 42602828
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- From Single Child to Family Planning: Determinants of Returning to ART to Build the Desired Family in a Monocentric Italian Cohort.
- ClinicalTrials.gov ID
- NCT07458165
- Acronym / sponsor ID
- FromSich / GIN2/OSS001/2025
- Keywords
- return rate, cryopreservation, family building
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 5,852 participants (actual)
- Lead sponsor
- Istituto Clinico HumanitasUniversity, hospital or other
- Study start
- Jan 2010 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 9 Mar 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.
This monocentric retrospective cohort study aims to investigate reproductive behavior and subsequent family-building outcomes in couples who achieved a first live birth through assisted reproductive technology (ART) at a university-affiliated fertility center in Italy. All couples obtaining a first live birth between January 2010 and December 2020 will be included and followed until December 2024. The primary objective is to evaluate the rate of return for further ART treatment after the first live birth. Secondary objectives include assessing cumulative live birth rate (CLBR) for the second and third live birth. Associations between return behavior and clinical factors, including maternal age, presence of cryopreserved oocytes or embryos, and treatment characteristics, will be analyzed.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Non-returners | – | –Couples who achieved a first live birth through ART at the study center and did not return for further ART treatment after the index birth during the follow-up period. |
| Returners | – | –Couples who achieved a first live birth through ART at the study center and subsequently returned to undergo one or more additional ART cycles for further reproductive attempts during follow-up. |
Who may qualify
- Ages
- 18 to 43 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- The study included all couples who underwent and completed ART cycles and achieved a first live birth between January 2010 and December 2020, who subsequently returned for new attempts, and met the following inclusion criteria: being a heterosexual couple with maternal age between 18 and 43 years, having complete clinical and demographic data available in the internal database, and having follow-up information up to December 2024
Key inclusion criteria (3 listed)
- Copules underwent ART treatment at the Humanitas Fertility Center (Rozzano, Milan)
- Copules achieved a first clinical pregnancy resulting from ART between January 2010 and December 2020
- heterosexual couples in which the maternal age was between 18 and 43 years old
Key exclusion criteria (3 listed)
- Couples who did not meet the inclusion criteria
- ART cycles involving preimplantation genetic testing for aneuploidy (PGT-A)
- Use of donor gametes (oocyte or sperm donation)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Return rate of couples who had achieved a first pregnancy and returned to pursue a second child.
Time frame: From January 2010 to December 2024
Analysis of the return rate of couples who had already achieved a first pregnancy and pursued a second child, with a comprehensive evaluation of the clinical, demographic, and treatment-related factors that may influence their likelihood of returning for additional ART attempts. This analysis aims to identify which characteristics are associated with a higher or lower probability of continuing their family-building journey after the initial live birth.
1 secondary outcome
Cumulative live birth rate of couples who had already achieved a first live birth and attempted to conceive a second child
Time frame: From January 2010 to December 2024
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 10 Mar 2026.
- Derived from this study: PubMed 42602828Viciglione F, Immediata V, Morenghi E, Alviggi C, Baggiani A, Cirillo F, Levi-Setti PE. From a single child to family planning: determinants of returning to ART to build the desired family in a monocentric Italian cohort. Hum Reprod Open. 2026 Jul 21;2026(3):hoag063. doi: 10.1093/hropen/hoag063. eCollection 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared due to the retrospective design of the study and institutional data protection policies. Only aggregated, anonymized results will be made available in the published manuscript.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Infertility Assisted Reproductive Technology, run by Istituto Clinico Humanitas.
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 3 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 10 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
Return rate of couples who had achieved a first pregnancy and returned to pursue a second child. (time frame: From January 2010 to December 2024). 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 NCT07458165, which also lists 1 linked publication.
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 10 Mar 2026.