Fertility IssuesNCT05223764
Why Are Fertility Preservation Patients Not Coming Back?
An observational study of Fertility Issues and Cancer, run by Istituto Clinico Humanitas at 1 site in Italy.
Trial summary
This is a single-center retrospective study carried out with a phone call follow-up to investigate women's decision not to return for criopreserved ovocytes use after cancer treatment. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Fertility Issues, Cancer
- What is being tested?
- Follow up survey
- How many people
- 172 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jun 2021to 1 Jan 2022
- 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 50 years
- Women only
- No healthy volunteers
- Adult
Study population: Women with an oncological diagnosis who underwent ovarian stimulation and oocytes retrivial and cryopreservation for fertility preservation
Who may be able to join
- The study database includes all women who underwent fertility preservation cycles at a third-level university-affiliated center
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Why Are They Not Coming Back? A Single-center Follow-up Study in Fertility Preservation in Oncological Women.
This is a single-center retrospective study carried out with a phone call follow-up to investigate women's decision not to return for criopreserved ovocytes use after cancer treatment. The study database includes all women who underwent fertility preservation cycles at a third-level university-affiliated center from January 2001 to December 2017.
Patients were asked a set of standardized questions whose purpose was to investigate their present health conditions, cancer treatment and any potential relapses, their family projects and sentimental status, any spontaneous conception, and why they had not yet returned for embryo transfer.
All data were recorded anonymously in our dataset.
Read the detailed description
All women who underwent oocyte cryopreservation cycles for oncological purposes from January 2001 to December 2017 at Fertility Center of Humanitas Research Hospital, Rozzano (Milano), Italy, were contacted.
The survey's purpose was to investigate their present health conditions, cancer treatment and any potential relapses, their family projects and sentimental status, any spontaneous conception, and why they had not yet returned for oocytes use.
- Conditions
- Fertility Issues, Cancer
- Being tested
- Follow up survey
- Medical subject headings
- Infertility, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Follow up surveyOther
phone call follow-up to investigate women's decision not to return for embryo transfer after cancer treatment.
| Study group | Role | What they receive |
|---|---|---|
| Fertility preservation population | all women who underwent oocyte cryopreservation cycles for oncological purposes from January 2001 to December 2017 at Fertility Center of Humanitas Research Hospital, Rozzano (Milano), Italy Receives: Other: Follow up survey |
What is being measured
The primary outcome is the main question the study is designed to answer.
return rate
return rate of cancer patients who underwent fertility preservation
Measured: from January 2001 to December 2021
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2022
- Study start1 Jun 2021
- Primary completion31 Dec 2021
- Study completion1 Jan 2022
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 Fertility IssuesStudies 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 172 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istituto Clinico Humanitas
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05223764
- Sponsor's protocol ID
- 72/20
- Status last verified
- Jan 2022
- First submitted
- 24 Jan 2022
- Last updated
- 4 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Immediata V, Cirillo F, Baggiani A, Zanagnolo MF, Ronchetti C, Morenghi E, Cesana A, Specchia C, Levi-Setti PE. Why are they not coming back? A single-center follow-up study on oncological women oocyte's storing for fertility preservation. Front Endocrinol (Lausanne). 2022 Dec 6;13:1054123. doi: 10.3389/fendo.2022.1054123. eCollection 2022.
PubMed 36561560
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Why Are They Not Coming Back? A Single-center Follow-up Study in Fertility Preservation in Oncological Women.
- ClinicalTrials.gov ID
- NCT05223764
- Acronym / sponsor ID
- 72/20
- Conditions
- Fertility Issues, Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 172 participants (actual)
- Lead sponsor
- Istituto Clinico HumanitasUniversity, hospital or other
- Study start
- 1 Jun 2021 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 1 Jan 2022 (actual)
- First posted
- 4 Feb 2022 (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.
This is a single-center retrospective study carried out with a phone call follow-up to investigate women's decision not to return for criopreserved ovocytes use after cancer treatment. The study database includes all women who underwent fertility preservation cycles at a third-level university-affiliated center from January 2001 to December 2017.
Patients were asked a set of standardized questions whose purpose was to investigate their present health conditions, cancer treatment and any potential relapses, their family projects and sentimental status, any spontaneous conception, and why they had not yet returned for embryo transfer.
All data were recorded anonymously in our dataset.
Detailed description
All women who underwent oocyte cryopreservation cycles for oncological purposes from January 2001 to December 2017 at Fertility Center of Humanitas Research Hospital, Rozzano (Milano), Italy, were contacted.
The survey's purpose was to investigate their present health conditions, cancer treatment and any potential relapses, their family projects and sentimental status, any spontaneous conception, and why they had not yet returned for oocytes use.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Fertility preservation population | – | Other: Follow up surveyall women who underwent oocyte cryopreservation cycles for oncological purposes from January 2001 to December 2017 at Fertility Center of Humanitas Research Hospital, Rozzano (Milano), Italy |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Women with an oncological diagnosis who underwent ovarian stimulation and oocytes retrivial and cryopreservation for fertility preservation
Key inclusion criteria (1 listed)
- The study database includes all women who underwent fertility preservation cycles at a third-level university-affiliated center
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Follow up surveyphone call follow-up to investigate women's decision not to return for embryo transfer after cancer treatment. | Other | Fertility preservation population |
Primary outcome
return rate
Time frame: from January 2001 to December 2021
return rate of cancer patients who underwent fertility preservation
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 4 Feb 2022.
- Derived from this study: PubMed 36561560Immediata V, Cirillo F, Baggiani A, Zanagnolo MF, Ronchetti C, Morenghi E, Cesana A, Specchia C, Levi-Setti PE. Why are they not coming back? A single-center follow-up study on oncological women oocyte's storing for fertility preservation. Front Endocrinol (Lausanne). 2022 Dec 6;13:1054123. doi: 10.3389/fendo.2022.1054123. eCollection 2022.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Fertility Issues and Cancer, 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 1 inclusion and 0 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 4 Feb 2022. 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?
return rate (time frame: from January 2001 to December 2021). 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 NCT05223764, 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 4 Feb 2022.