From a Single Child to Family Planning (FromSich)

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.

Study Overview

• Status: Completed
• Conditions: Infertility Assisted Reproductive Technology

• Study Type: Observational
• Enrollment (Actual): 5852

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

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

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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)

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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 the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	From January 2010 to December 2024

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	From January 2010 to December 2024

Collaborators and Investigators

• Sponsor: Istituto Clinico Humanitas

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2010
• Primary Completion (Actual): December 31, 2024
• Study Completion (Actual): December 31, 2024

Study Registration Dates

• First Submitted: March 3, 2026
• First Submitted That Met QC Criteria: March 3, 2026
• First Posted (Actual): March 9, 2026

Study Record Updates

• Last Update Posted (Actual): March 10, 2026
• Last Update Submitted That Met QC Criteria: March 7, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: cryopreservation; return rate; family building
• Other Study ID Numbers: GIN2/OSS001/2025; Ethics committee No. 4773 (Other Identifier: Humanitas Research Hospital)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No