Ignite Creation Date:
2024-05-06 @ 8:20 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06344585
Status:
COMPLETED
Last Update Posted:
2024-04-24
First Post:
2024-03-27
Brief Title:
Drop-out of Infertile Couples a Large Single Center Experience Over 10 Years
Sponsor:
Istituto Clinico Humanitas
Organization:
Istituto Clinico Humanitas
Study Overview
Official Title:
Drop-out of Infertile Couples a Prospective Study in Which Dropout Women in 2021 Were Enrolled to Answer to a Questionnaire Exploring Their Reasons and a Retrospective Study Which Explored the Factors for Dropout Over 10 Years
Status:
COMPLETED
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
dropout
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
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
Detailed Description:
Background In recent years refinements and improvements in In vitro Fertilization and embryo transfer IVF-ET techniques have significantly enhanced the efficacy of infertility treatments offering renewed hope to countless couples struggling with conception Simultaneously there has been a notable surge in the number of couples seeking IVF procedures Studies indicate that under optimal conditions approximately 83 of women undergoing IVF treatment could achieve a live birth within eight complete cycles a rate comparable to natural conception among fertile non-contraceptive users Despite these encouraging statistics a significant portion of couples discontinue treatment prematurely
Objectives The study aims at evaluating the dropout rate among couples following their first access to the Fertility Center It seeks to elucidate the concept of treatment continuation versus dropout and to identify the determinants influencing these decisions among infertile couples Additionally the study aims at investigating the factors contributing to non-return among patients who did not proceed with further treatment
Materials and methods 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 arm 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
Furthermore all collected data were anonymized and all patients signed an informed consent to use their data for research purposes A univariate analysis was performed to compare characteristics between returning and non-returning couples
Objectives The study aims at evaluating the dropout rate among couples following their first access to the Fertility Center It seeks to elucidate the concept of treatment continuation versus dropout and to identify the determinants influencing these decisions among infertile couples Additionally the study aims at investigating the factors contributing to non-return among patients who did not proceed with further treatment
Materials and methods 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 arm 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
Furthermore all collected data were anonymized and all patients signed an informed consent to use their data for research purposes A univariate analysis was performed to compare characteristics between returning and non-returning couples
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None