Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Infertility

Genital Diseases

Urogenital Diseases

All Drugs and Chemicals

Hormones

women 5-45 yr olf pre and post chemotherapy

time 0 is pretreatment time 3, 6 , 9, 12 months from the end of chemotherapy

blood tests

Ariel Revel, MD

young female cancer patients have improving chances of survival. the main risk is a chronic damage to their ovarian reserve. This may lead to future infertility.

our objective is to prospectively follow patients before and after their cancer treatment. this should help us learn of the gonadotoxicity of various treatments as well as be able to better consult these and future patients of the need of fertility preservation techniques.

Anti-Mullerian Hormone (AMH) and Antral Follicle Count as Markers of Ovarian Reserve- Prospective Followup of Young Cancer Patients

Phase 1 Prospective Study of Markers of Ovarian Reserve in Young Female Cancer Patients

Hadassah Medical Organization

Fertility status before and after gonadotoxic treatment

Blood samples for analysis

Sperm samples for analysis

Satisfaction evaluation

Short-Form 12-items health survey (SF-12)

Quality of Life questionnaire

Michael von Wolff, Prof. Dr.

The goal of this observational study is to learn how gonadotoxic treatments (chemotherapies, radiotherapies or immunotherapies) affect the fertility status of participants with cancer.

The main questions it aims to answer are:

* in females, if cancer therapies reduce the Anti-Müllerian hormone (AMH) concentration (ovarian reserve);
* in males, if cancer therapies reduce sperm concentration (sperm quality).

This is an international multicenter prospective exploratory study of fertility related data generated mostly routinely in fertility centers in Switzerland belonging to the Swiss network "FertiSAVE" as well as in fertility centers in Germany and Austria belonging to the German-Swiss-Austrian network "FertiPROTEKT" and further international centers who are interested to participate. Both networks include in total around 200 centers.

The data, which are mainly part of the routine clinical care, will be collected by the physicians and added to the REDcap study registry. Patients will be coded by the center to be able to follow them up. Each center will only have access to its own registry data set. Access to the total data set is only permitted for the principal investigator and the specific sub-investigators.

Data collection before the start of gonadotoxic treatment will be performed for 5 years.

Data collection after the end of gonadotoxic treatment will be performed for 10 years (time points: at 12-15 months, at 5 years and at 10 years).

Impact of Gonadotoxic Therapies on Fertility

FertiTOX - Platform for Fertility Related Gonadotoxicity of Cancer Therapies

Fertility status after gonadotoxic treatment in females (referring to ovarian reserve).

Blood will be drawn to measure AMH concentration. Unit of measure: for serum AMH value is picomol per liter (pmol/L).

Fertility status after gonadotoxic treatment in males (referring to sperm quality).

Participants provide the laboratory with a sperm sample for analysis. Unit of measure: for sperm concentration is millions per milliliter (10\^6/mL).

Proportion of female participants who freeze their ovarian tissue, oocytes, zygotes or embryos.

Proportion of male participants who freeze their sperm or testicular tissue.

Both female and male participants will have to rate their counselling satisfaction by choosing a score on a scale from 1 to 10. Value 1, being the lowest score (not satisfied at all) and value 10 being the highest score (very satisfied).

Both female and male participants will have to rate their decisional satisfaction by choosing a score on a scale from 1 to 10. Value 1, being the lowest score (not satisfied at all) and value 10 being the highest score (very satisfied).

Pregnancies which occured naturally, without the help of fertility preservation measures.

Pregnancies which occured with the help of fertility preservation measures (in females: frozen ovarian tissue, oocytes, zygotes or embryos, and in males: frozen sperm or testicular tissue).

Short-Form 12-items health survey (SF-12, version 2) is a questionnaire that consists of 12 questions. It investigates the participant's state of health through 8 different dimensions: general health perception (1 question), physical health (2 questions), limited physical role function (2 questions), physical pain (1 question), vitality (1 question), mental health (2 questions), limited emotional role function (2 questions) and social functioning (1 question).

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Anti-Mullerian Hormone (AMH) and Antral Follicle Count as Markers of Ovarian Reserve- Prospective Followup of Young Cancer Patients	NCT00930501	Infertility	blood tests	5 Years - 45 Years	Hadassah Medical Organization
Impact of Gonadotoxic Therapies on Fertility	NCT05885048	Cancer Fertility Issue... Fertility Prese... Toxicity Due to... Toxicity Due to... Effects of Immu...	Blood samples f... Sperm samples f... Satisfaction ev... Quality of Life...	14 Years - 50 Years	Universitätsklinik fur Frauenheilkunde, Inselspital Bern
Anti-Mullerian Hormone (AMH) and Antral Follicle Count as Markers of Ovarian Reserve- Prospective Followup of Young Cancer Patients	NCT00930501	Infertility	blood tests	5 Years - 45 Years	Hadassah Medical Organization

Spots Global Cancer Trial Database for gonadotoxicity