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OpenTrials
Completed

NCT Number: NCT07458165

From a Single Child to Family Planning

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.

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Key information

Age range

18 year–43 year

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Primary outcomes

  1. 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

  1. 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

    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

Sponsors and collaborators

Lead sponsor

Istituto Clinico Humanitas

Other

Registry information

Official study title

From Single Child to Family Planning: Determinants of Returning to ART to Build the Desired Family in a Monocentric Italian Cohort.

Acronym: FromSich

Important dates

Study start
2010
Primary completion
2024
Study completion
2024
First posted
Mar 9, 2026
Registry last updated
Mar 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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