NCT05223764

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
172

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2021

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2021

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2022

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

January 24, 2022

Completed
11 days until next milestone

First Posted

Study publicly available on registry

February 4, 2022

Completed
Last Updated

February 4, 2022

Status Verified

January 1, 2022

Enrollment Period

7 months

First QC Date

January 24, 2022

Last Update Submit

January 24, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • return rate

    return rate of cancer patients who underwent fertility preservation

    from January 2001 to December 2021

Study Arms (1)

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

Other: Follow up survey

Interventions

phone call follow-up to investigate women's decision not to return for embryo transfer after cancer treatment.

Fertility preservation population

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Women with an oncological diagnosis who underwent ovarian stimulation and oocytes retrivial and cryopreservation for fertility preservation

You may qualify if:

  • The study database includes all women who underwent fertility preservation cycles at a third-level university-affiliated center

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Valentina Immediata

Milan, MI, 20141, Italy

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

InfertilityNeoplasms

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 24, 2022

First Posted

February 4, 2022

Study Start

June 1, 2021

Primary Completion

December 31, 2021

Study Completion

January 1, 2022

Last Updated

February 4, 2022

Record last verified: 2022-01

Locations