From a Single Child to Family Planning

NCT07458165 | Completed

• 2 other identifiers: GIN2/OSS001/2025Ethics committee No. 4773
• Study Type: observational
• Target: 5,852
• Locations: 0 countries
• Sites: N/A

Brief 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. 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.

Conditions

Infertility Assisted Reproductive Technology

Keywords

return rate; cryopreservation; family building

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Cumulative live birth rate of couples who had already achieved a first live birth and attempted to conceive a second child

  From January 2010 to December 2024

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years - 43 Years
• Gender Eligibility Details: Eligibility was determined by biological sex, as the study included exclusively heterosexual couples undergoing ART. Gender identity did not influence inclusion or exclusion criteria.
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• 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

You may qualify if:

• 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

You may not qualify if:

• ART cycles involving preimplantation genetic testing for aneuploidy (PGT-A)
• Use of donor gametes (oocyte or sperm donation)

Sponsors & Collaborators

• Istituto Clinico Humanitas: lead

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dottor

Study Record Dates

• First Submitted: March 3, 2026
• First Posted: March 9, 2026
• Study Start: January 1, 2010
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: March 10, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share