Drop-out of Infertile Couples: a Large Single Center Experience Over 10 Years

NCT06344585 | Completed DMC

• 1 other identifier: DROPOUT
• Study Type: observational
• Target: 24,773
• Locations: 1 country
• Sites: 1

Brief Summary

Conducted at a single-center, this prospective-retrospective study focused on all couples who initiated their journey at the Fertility Center of Humanitas Research Hospital, Rozzano (Milan), Italy. The prospective study focused on the couples whose first consultation occurred in 2021. A tailored questionnaire was administered via telephone by staff members to gather insights into the personal reasons for treatment discontinuation among non-returning patients. Conversely, the retrospective study included all infertile couples initiating treatment between January 2012 and December 2021 at the Fertility Center. Data encompassing personal history and demographic details were extracted from the internal database of Humanitas Fertility Center to assess the factors involved in a treatment discontinuation.

Conditions

Infertility

Keywords

infertility; dropout

Outcome Measures

Primary Outcomes (1)

• Dropout rate

  The primary objective of this study was to determine the dropout rate of infertile couples after their first access to Humanitas Fertility Center.

  10 years

Secondary Outcomes (1)

• Reasons for dropout collected by a phone call questionnaire

  10 years

Study Arms (2)

Drop out

Women who had their first access from 2012 to 2021 and never returned back

Other: Drop out patients who had their first access in 2021 were additionally asked to answer to a phone -call questionnaire to assess their motivation of discontinuation

Non drop out

Women who had their first access from 2012 to 2021 and returned back for subsequent treatment

Interventions

Drop out patients who had their first access in 2021 were additionally asked to answer to a phone -call questionnaire to assess their motivation of discontinuation OTHER

A prospective comprehensive analysis of the data contained within patient charts, encompassing personal histories and demographic details, was extracted from the internal database of the Humanitas Fertility Center. This analysis aimed at elucidating the individual reasons for treatment discontinuation after the initial clinical visit throughout the year 2021. Additionally a tailored questionnaire was administered to patients via telephone by a member of Humanitas Fertility Center staff in July 2023. The questionnaire was submitted to the patients via a phone call. The questionnaire comprised nine questions with response limited to 'Yes' and 'No' options for all queries.

Drop out

Eligibility Criteria

• Age: 18 Years - 46 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

All infertile couples who had their first access at the Fertility Center of Humanitas Research Hospital, situated in Rozzano (Milan), Italy, between January 2012 and December 2021.

You may qualify if:

• The prospective study focused on patients discontinuing treatment following their initial visit to the Fertility Center of Humanitas Research Hospital, situated in Rozzano (Milan), Italy in 2021. These individuals were contacted by our staff and provided with a specific questionnaire via phone call.
• Conversely, the retrospective arm included all infertile couples initiating treatment between January 2012 and December 2021 at the same Center.

You may not qualify if:

• Excluded from our analysis were women not seeking conception.

Sponsors & Collaborators

• Istituto Clinico Humanitas: lead

Study Sites (1)

Istituto Clinico Humanitas

Rozzano, Milano, 20089, Italy

Location

Related Publications (1)

• Scognamiglio C, Cirillo F, Ronchetti C, Secchi M, Busnelli A, Morenghi E, Alviggi C, Levi-Setti PE. From hope to hesitation: why couples fail to return for infertility treatment after the first consultation. Hum Reprod. 2025 May 1;40(5):919-925. doi: 10.1093/humrep/deaf012.

  PMID: 40096631 DERIVED

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Study Officials

• Paolo Emanuele Levi Setti

  Humanitas Research Hospital IRCCS, Rozzano-Milan

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 27, 2024
• First Posted: April 3, 2024
• Study Start: January 1, 2012
• Primary Completion: December 31, 2021
• Study Completion: July 31, 2023
• Last Updated: April 24, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)