Diseases and Abnormalities at or Before Birth

All Conditions

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Congenital Abnormalities

Abortion, Spontaneous

Pregnancy Complications

Urogenital Diseases

Female Urogenital Diseases

Female Urogenital Diseases and Pregnancy Complications

All Drugs and Chemicals

Hormones

Vincent F Garry, MD

This project is designed to establish whether pesticides or other environmental agents have a role in the excess birth defects identified in the Red River Valley of Minnesota. In this human study, laboratory based health parameters will be used to key in health survey data. In vitro data will be developed to mechanistic information. Concordant results among these study features will provide a weight of evidence approach.

Pesticides--Health Fertility and Reproductive Risk

National Institute of Environmental Health Sciences (NIEHS)

Blood and Lymph Conditions

Hematologic Diseases

Anti-Inflammatory Agents

Hypoglycemic Agents

Reproductive Control Agents

Antibodies

Hydrocortisone

Hydrocortisone 17-butyrate 21-propionate

Hydrocortisone acetate

Hydrocortisone hemisuccinate

Insulin

Insulin, Globin Zinc

Follicle Stimulating Hormone

Immunoglobulins

Estradiol 17 beta-cypionate

Estradiol 3-benzoate

Estradiol

Polyestradiol phosphate

Testosterone

Mitogens

Adrenocorticotropic Hormone

Melanocyte-Stimulating Hormones

beta-Endorphin

Young adult men (≥18 years) cured of childhood cancer or hematological disorders for which they received high-risk gonadotoxic treatment during childhood and who have chosen to undergo a testicular biopsy procedure at a young age as a fertility preservation strategy.

Young adult men (≥18 years) cured of childhood cancer or hematological disorders for which they received high-risk gonadotoxic treatment during childhood and who have refused to undergo a testicular biopsy procedure at a young age as a fertility preservation strategy.

Spontaneously conceived young adults whose data on reproductive health have already been published (Belva F et al., 2016/2017/2019).

A physical examination to measure the patients' weight, height, body mass index, blood pressure and testicular volume using a Prader orchidometer and to determine the patients' Tanner stage (secondary sexual development).

Physical examination

A scrotum ultrasound to measure the patients' testicular volume and to investigate potential abnormalities in the testicular parenchyma.

Scrotum ultrasound

A morning blood sample to evaluate the serum levels of luteinizing hormone (LH), follicle-stimulating hormone (FSH), testosterone (T), estradiol (E2), inhibin B (INHB), thyroid-stimulating hormone (TSH), free thyroxine (FT4), insulin-like growth factor 1 (IGF1), prolactin (PRL), cortisol and adrenocorticotropic hormone (ACTH). Upon approval by the patient himself, a spare blood sample will be collected and retained for 5 years for subsequent research purposes limited to the context of the present study.

Blood sample

A semen analysis to evaluate ejaculate volume, sperm concentration, sperm motility, and sperm morphology. If sperm is found in the semen sample, an anti-sperm antibody test and a sperm DNA fragmentation test will be performed. Upon approval by the patient himself, the surplus of the semen sample will be retained for 5 years for subsequent research purposes limited to the context of the present study.

Semen analysis

Ellen Goossens, Prof. Dr.

The goal of this prospective comparative interventional cohort study is to assess the fertility status of young adult men (≥18 years) who received gonadotoxic treatment during childhood for the treatment of cancer or hematological disorders. These treatment protocols are highly gonadotoxic (i.e. they may cause later fertility problems) and therefore these patients have been proposed to store some testicular tissue during childhood as an option to preserve their fertility.

The main questions this study aims to answer are (1) the impact of the received gonadotoxic treatment on the later fertility status and (2) the additional impact of a testicular biopsy procedure (performed at a young age to harvest testicular tissue for storage) on the future fertility.

Participants will be asked to undergo a physical examination by a fertility specialist, to undergo a scrotal ultrasound, to give a blood sample, and to provide a semen sample.

Researchers will compare the patients\&amp;#39; fertility status between the different received gonadotoxic treatment protocols, between patients who underwent a testicular biopsy procedure at a young age and those who did not, and compare the patients\&amp;#39; fertility status with the reproductive health of spontaneously conceived young adults.

This study is a prospective comparative interventional cohort study.

The fertility status of young adults (≥18 years) cured of childhood cancer or hematological disorders for which they received high-risk gonadotoxic treatment (with an ≥80% risk of later fertility problems) during childhood will be compared between patients who did and those who did not undergo a testicular tissue biopsy procedure at a young age as a fertility preservation strategy in order to identify a possible association between the biopsy procedure (which is performed to harvest testicular tissue) and the later fertility outcome.

Their fertility status will also be compared to the reproductive health of spontaneously conceived young adults that has already been published (Belva F et al., 2016/2017/2019).

Fertility in Young Adults Who Did (Not) Store Testicular Tissue Before a Treatment Leading to Fertility Problems

Follow-up of Fertility in Young Adults Who Did or Did Not Store Testicular Tissue Before Gonadotoxic Treatment for Fertility Preservation

The patients' fertility status (physical examination, scrotum ultrasound, blood sample, semen analysis) will be evaluated once a year after cessation of the gonadotoxic treatment. Only in case of infertility (azoospermia) or subfertility (oligo-, astheno- or teratozoospermia), the different interventions will be repeated one year later as the recovery of spermatogenesis with return of sperm production may occur several years after gonadotoxic treatment.

Vrije Universiteit Brussel

Universitair Ziekenhuis Brussel

Head of research group BITE

Neoplasms

Prostatic Neoplasms

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Prostatic Diseases

Male Urogenital Diseases

Analysis of semen before and after proton radiation therapy.

Semen analysis before and after proton radiation therapy.

Bradford S Hoppe, MD, MPH

The purpose of this study is to evaluate semen for changes following treatment with proton radiation therapy.

Semen Analysis After Proton Therapy for Prostate Cancer

Semen Analysis Following Definitive Treatment of Prostate Cancer With Proton Radiation Therapy Alone

University of Florida

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Pesticides--Health Fertility and Reproductive Risk	NCT00015561	Birth Defects Miscarriages Cancer		18 Years - 70 Years	National Institute of Environmental Health Sciences (NIEHS)
Fertility in Young Adults Who Did (Not) Store Testicular Tissue Before a Treatment Leading to Fertility Problems	NCT04202094	Childhood Cance... Hematological D...	Physical examin... Scrotum ultraso... Blood sample Semen analysis	18 Years -	Universitair Ziekenhuis Brussel
Semen Analysis After Proton Therapy for Prostate Cancer	NCT01072513	Prostate Cancer	Semen analysis	18 Years -	University of Florida

Spots Global Cancer Trial Database for semen analysis