InfertilitydropoutNCT06344585
Drop-out of Infertile Couples: a Large Single Center Experience Over 10 Years
An observational study of Infertility, run by Istituto Clinico Humanitas at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 46 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Infertility
- What is being tested?
- 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
- How many people
- 24,773 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jan 2012to 31 Jul 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 46 years
- Women only
- Healthy volunteers accepted
- Adult
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.
Who may be able to join
- 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.
Who cannot join
- Excluded from our analysis were women not seeking conception.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Infertility
- Being tested
- 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
- Keywords
- infertility, dropout
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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 discontinuationOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Drop out | Women who had their first access from 2012 to 2021 and never returned back Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 10 years
Secondary outcomes (1)
Reasons for dropout collected by a phone call questionnaire
Secondary aim was to assess the determinants in infertile couples influencing their choice not to return.
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2024
- Study start1 Jan 2012
- Primary completion31 Dec 2021
- Study completion31 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for InfertilityStudies of the same condition, open and under way.
- More trials run by Istituto Clinico HumanitasThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 24,773 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istituto Clinico Humanitas
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Paolo Emanuele Levi Setti, Study director, Humanitas Research Hospital IRCCS, Rozzano-Milan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06344585
- Sponsor's protocol ID
- DROPOUT
- Acronym
- dropout
- Status last verified
- Apr 2024
- First submitted
- 27 Mar 2024
- Last updated
- 24 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Only under request
Publications
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.
PubMed 40096631
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06344585
- Acronym / sponsor ID
- dropout / DROPOUT
- Conditions
- Infertility
- Keywords
- infertility, dropout
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 24,773 participants (actual)
- Lead sponsor
- Istituto Clinico HumanitasUniversity, hospital or other
- Study start
- 1 Jan 2012 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Jul 2023 (actual)
- First posted
- 3 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Drop out | – | 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 discontinuationWomen who had their first access from 2012 to 2021 and never returned back |
| Non drop out | – | –Women who had their first access from 2012 to 2021 and returned back for subsequent treatment |
Who may qualify
- Ages
- 18 to 46 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (1 listed)
- Excluded from our analysis were women not seeking conception.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 discontinuationA 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. | Other | Drop out |
Primary outcome
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.
1 secondary outcome
Reasons for dropout collected by a phone call questionnaire
Time frame: 10 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2024.
- Derived from this study: PubMed 40096631Scognamiglio 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.
- Individual participant dataSharing planned: No. Only under request
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paolo Emanuele Levi Setti study director
Humanitas Research Hospital IRCCS, Rozzano-Milan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Infertility, run by Istituto Clinico Humanitas at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dropout rate (time frame: 10 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06344585, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2024.