From Single Child to Family Planning: Determinants of Returning to ART to Build the Desired Family in a Monocentric Italian Cohort.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 5,852
- Primary Endpoint
- Return rate of couples who had achieved a first pregnancy and returned to pursue a second child.
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Retrospective
Eligibility Criteria
- Ages
- 18 Years to 43 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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)
Arms & Interventions
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.
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.
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- 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)
Investigators
Michele Tedeschi
Dottor
Istituto Clinico Humanitas