NCT06360471

Brief Summary

To explore whether there is a significant difference in the cumulative live birth rate and maternal and child health outcomes between cancer patients who undergo or do not undergo fertility preservation before receiving anti-tumor treatment and non-cancer patients who undergo assisted reproductive technology treatment/natural pregnancy. This study will be conducted in the Clinical Center of Reproductive Medicine, First Affiliated Hospital of Nanjing Medical University. 2800 women diagnosed with malignant cancers who has desire to reproduce will be enrolled in this study. Statistical analysis of the data will be performed.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
2,800

participants targeted

Target at P75+ for all trials

Timeline
78mo left

Started Oct 2023

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress29%
Oct 2023Oct 2032

Study Start

First participant enrolled

October 1, 2023

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

April 7, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 11, 2024

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2027

Expected
5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2032

Last Updated

April 16, 2024

Status Verified

April 1, 2024

Enrollment Period

4 years

First QC Date

April 7, 2024

Last Update Submit

April 15, 2024

Conditions

Fertility IssuesCancer

Keywords

fertility preservationcancer

Outcome Measures

Primary Outcomes (1)

  • 5-year cumulative live birth rate

    5-year cumulative live birth rate for female patients who reproduce

    5 years

Secondary Outcomes (5)

  • Ovarian function(AMH levels)

    5 years

  • Ovarian function(AFC counts)

    5 years

  • Newborn malformation rate

    5 years

  • Tumor recurrence rate

    5 years

  • Tumor survival rate

    5 years

Study Arms (2)

Fertility preservation

patients who choose fertility preservation

Other: fertility preservation

Observation

patients who choose observation

Interventions

fertility preservationOTHER

If a patient have a desire to fertility preservation, oocyte freezing or embryo freezing will be offered.

Fertility preservation

Eligibility Criteria

Age20 Years - 40 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsFemale patients
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

2800 female cancer patients who have fertility desire

You may qualify if:

  • Tumor confirmed (main focus: breast cancer, hematological disease/lymphoma, gynecological tumor (ovarian cancer), boundary tumors, nasopharyngeal cancer, colorectal cancer, and other tumors that require anti-tumor treatment;
  • Having a desire for future fertility(including women who have already given birth);
  • Age: 20-40 years old (patients planning to freeze their eggs are ≤35 years old, and those planning to freeze their embryos are ≤40 years old);
  • Consent.

You may not qualify if:

  • Patients with congenital or acquired uterine abnormalities, severe intrauterine adhesions, and other diseases that have a clear impact on pregnancy;
  • Those with assisted reproductive technology and pregnancy contraindications;
  • Tumors that are not suitable for pregnancy after multidisciplinary discussions on tumor fertility;
  • Clinical diagnosis of POI (premature ovarian insufficiency).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinical Center of Reproductive Medicine of First Affiliated Hospital with Nanjing Medical University

Nanjing, Jiangsu, 210000, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

the patient blood samples were collected for further study

MeSH Terms

Conditions

InfertilityNeoplasms

Interventions

Fertility Preservation

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Intervention Hierarchy (Ancestors)

Reproductive Techniques, AssistedReproductive TechniquesTherapeuticsTissue and Organ HarvestingTransplantationSurgical Procedures, OperativeInvestigative Techniques

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
5 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 7, 2024

First Posted

April 11, 2024

Study Start

October 1, 2023

Primary Completion (Estimated)

October 1, 2027

Study Completion (Estimated)

October 1, 2032

Last Updated

April 16, 2024

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will share

Study protocol can be shared

Shared Documents
STUDY PROTOCOL
Time Frame
5 years

Locations

CN(1)