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

April 23, 2024 updated by: Istituto Clinico Humanitas

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
24773

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • Milano
      • Rozzano, Milano, Italy, 20089
        • Istituto Clinico Humanitas

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

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.

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • Excluded from our analysis were women not seeking conception.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Dropout rate
Time Frame: 10 years
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Reasons for dropout collected by a phone call questionnaire
Time Frame: 10 years
Secondary aim was to assess the determinants in infertile couples influencing their choice not to return.
10 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Istituto Clinico Humanitas

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Paolo Emanuele Levi Setti, IRCCS Humanitas Research Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2012

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 31, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 27, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 27, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 3, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 24, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 23, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • DROPOUT

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Only under request

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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