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NCT Number: NCT03180827

Female Fertility Preservation Using Ovarian Tissue Cryopreservation Before Highly Gonadotoxic Cancer Treatment

Background:

Due to the remarkable improvement in treatments these last decades, long term survival can be expected in more than 80% of childhood cancer patients. Unfortunately, cancer treatments can be harmful to the gonads and can affect reproductive and endocrine functions. While loss of fertility is a major concern for most patients, only the experimental option of ovarian tissue cryopreservation can be proposed to prepubertal girls with a high risk of infertility. For pubertal patient, cryopreservation of mature oocytes after ovarian stimulation can be offered if oncological treatment debut can be delayed. As it is often not possible, ovarian tissue cryopreservation can also be offered.

Primary aims

- To cryopreserve ovarian tissue of pre or peripubertal patient who will be receiving highly gonadotoxic oncological treatment.

Secondary aims

* To create a database in order to record clinical and biological follow-up data * To pool resources with Fertisave Registry * To create a research biobank for future research projects

Multicentric study: HUG, CHUV

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Childhood Cancer Fertility Disorders Neoplasms

Age range

2 month–18 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Geneva University Hospitals, Geneva, Switzerland

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Pediatric pre ou peripubertal patient aged 2 months and older
  • Patient presenting high risk of infertility because of gonadotoxic treatments (i.e. high dose of alkylating agents, ovarian irradiation, total body irradiation)
  • Multidisciplinary team consensus in favour to proposition to cryopreserve ovarian tissue.

Exclusion criteria

  • Patient under the age of 2 months
  • Refusal of the patient and/or her parents
  • Treatments that are not highly gonadotoxic

Treatment and study plan

ovarian tissue biopsy

Procedure

ovarian tissue biopsy during general anesthesia

Primary outcomes

  1. Number of pediatric cancer patient who will undergo ovarian tissue cryopreservation for fertility preservation

    Time frame: 0-20 years

Secondary outcomes

  1. Incidence of complications related to the ovarian biopsy (safety)

    Time frame: 0-20 years

    The safety will be assessed by recording the number of complications of the procedure (e.g. bleeding, infection)

  2. Comparison of biochemical markers

    Time frame: 0-20 years

    Comparison of biochemical markers (e.g., FSH; LH, AMH, progesterone, oestradiol) between patients who undergo ovarian biopsy and controls

Sponsors and collaborators

Lead sponsor

Gumy-Pause Fabienne

Other

Registry information

Important dates

Study start
2015
Primary completion
2100
Study completion
2100
First posted
Jun 8, 2017
Registry last updated
May 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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