Fertility Preservation and Pregnancy and Offspring Health Outcomes in Female Cancer

NCT ID: NCT06360471

Last Updated: 2024-04-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

2800 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-10-01

Study Completion Date

2032-10-01

Brief Summary

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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.

Detailed Description

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The number of new cancer cases among Chinese women in 2020 will be 2.09 million, showing a trend in younger age at the time of diagnosis. Incomplete statistics show that 25%\~30% of young breast cancer patients in China Need for fertility preservation. In this study, we want to answer the question: Does fertility preservation affect the prognosis in female cancer patients.

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.

If a female tumor patients (focusing on: breast cancer, hematological diseases/lymphoma, gynecological tumors (ovarian borderline tumors, etc.), nasopharyngeal cancer, colorectal cancer, etc.) have a desire to reproduce in the future, she would considered for enrollment. After being admitted into this study, according to the patients'own will, she will receive long term observation or fertility preservation followed by long term observation. Cumulative live birth rate, perinatal and perinatal complications, and offspring health of women who have or have not received fertility preservation before anti-tumor treatment and who have no tumor and who normally receive assisted reproductive technology treatment/natural pregnancy are all recorded, to assess the impact of the current new anti-tumor treatment on female fertility and offspring health.

Conditions

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Fertility Issues Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Fertility preservation

patients who choose fertility preservation

fertility preservation

Intervention Type OTHER

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

Observation

patients who choose observation

No interventions assigned to this group

Interventions

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fertility preservation

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

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

1. 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;
2. Having a desire for future fertility(including women who have already given birth);
3. 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);
4. Consent.

Exclusion Criteria

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

20 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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The First Affiliated Hospital with Nanjing Medical University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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

Nanjing, Jiangsu, China

Site Status RECRUITING

Countries

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China

Facility Contacts

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Xiang Ma, MD. PHD

Role: primary

+8618001581878

Nan Lu

Role: backup

+8615950476023

Other Identifiers

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FS-FMC

Identifier Type: -

Identifier Source: org_study_id

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