Fertility & Family Planning Considerations Before Clinical Trial Enrollment
Clinical trials play a critical role in advancing treatments for polycystic kidney disease (PKD) and many other medical conditions. If you're considering participating in a clinical trial, it's important to understand not only the potential benefits and risks of the study itself, but also how participation may affect your future family-building goals.
For individuals who hope to have children someday, taking time to discuss fertility preservation before enrolling in a clinical trial may provide additional options and peace of mind.
The following educational resource was made in collaboration with Jovana Levovich, MD.
Dr. Jovana Lekovich is a double board-certified OB/GYN and reproductive endocrinologist and infertility specialist who serves as Medical Director of RMA of New York–Brooklyn. She is also Director of the Oncofertility Program at Mount Sinai’s Blavatnik Family–Chelsea Medical Center and an Assistant Clinical Professor at the Icahn School of Medicine at Mount Sinai, with expertise in fertility preservation, oncofertility, IVF, preimplantation genetic testing, and LGBTQIA+ family building.
Why Fertility Matters Before a Clinical Trial
Many clinical trials involve medications or therapies whose effects on fertility or pregnancy are not yet fully understood. As a result, participants may be required to delay pregnancy during the study or avoid conception for a period of time after completing the course of the investigational therapy (commonly called a “washout” period).
Some studies may also involve therapies that have the potential to affect reproductive function, while others may have no known impact at all. Because every clinical trial is different, understanding these considerations before enrollment is essential.
Questions to Ask Before Enrolling
Before joining a clinical trial, consider discussing the following questions with both the study team and your healthcare providers:
Could participation affect my future fertility?
Will I need to avoid pregnancy during or for a period of time after the study?
How long should I wait after the trial concludes before trying to conceive?
Does this study recommend fertility preservation before enrollment?
Are there any known reproductive risks associated with the investigational treatment?
No question is too small when planning for your future family.
Understanding Fertility Preservation
Fertility preservation refers to medical options that may help individuals retain the possibility of having biological children in the future.
Depending on your age, medical history, and reproductive goals, these options may include:
For Females
Egg (oocyte) freezing
Embryo freezing
Ovarian tissue preservation (in select circumstances)
For Males
Sperm cryopreservation (freezing)
Appropriate Candidates for Fertility Preservation
For Females
· Being of reproductive age (15-45 years old)
· BMI < 40
· Reasonably good health and ability to undergo ovarian stimulation and egg retrieval (minor procedure that requires propofol and fentanyl anesthesia)
· A Creatinine < 1.5 mg/dL
· Medical clearance from their nephologist starting they are well enough to undergo minor procedure under propofol/fentanyl anesthesia
For Men
· Reasonably good health and medically eligible to undergo sperm cryopreservation as determined by the treating fertility center
· Complete and meet the fertility center's requirements for infectious-disease screening prior to cryopreservation
Special Considerations for Families Living with PKD
For individuals living with inherited forms of PKD, family planning decisions may involve additional considerations beyond fertility preservation alone.
Some families may choose to explore:
Genetic counseling
IVF
Preimplantation Genetic Testing for Monogenic Disorders (PGT-M)
These options allow some families to reduce the likelihood of passing PKD to future generations. However, every family's circumstances, values, and goals are unique, and there is no single "right" approach.
At PKD-Free Alliance, we believe every family deserves access to accurate information so they can make informed decisions that are right for them.
Timing Matters
One of the most important reasons to discuss fertility preservation early is that some options must be completed before beginning certain treatments or enrolling in a clinical trial.
Depending on the preservation method, the process may require additional planning and time.
Speaking with a fertility specialist early can help you understand your options without delaying important medical decisions unnecessarily.
For female patients pursing preventative oocyte cryopreservation, they should ideally be seen approximately 2-3 weeks prior to intendent start of the fertility preservation treatment (so the fertility preservation provider can order the medications, labs, and train the individual how to administer meds and submit treatment to their insurance). The actual process of ovarian stimulation and oocyte cryopreservation involves approximately 14 days from start to finish (8-10 days of medications, and an oocyte retrieval procedure as the last event in the cascade). Oocytes are frozen several hours after the egg retrieval.
For female/male patients pursuing PGT-M (and embryo cryopreservation), and who ideally have the genetic (besides clinical) diagnosis as well, it might take 4-8 weeks to prepare for their treatment. Most of this time is required to construct a personalized PGT-M probe in order to identify the mutation in the resulting embryos, which allows the fertility care provider to prevent propagation of this condition to the patient’s offspring. The actual process of ovarian stimulation involves approximately 14 days from start to finish (8-10 days of medications, and an oocyte retrieval procedure as the last event in the cascade). Oocytes are fertilized with sperm several hours after egg retrieval, and the embryos cultured for 5-7 days afterwards. At this point they can be tested for PKD (in addition to chromosomal testing). Patient involvement is the same as in case of oocyte cryopreservation (meaning the day of the retrieval is the end of their treatment, and everything else occurs in the embryology laboratory afterwards).
For male patients pursuing sperm cryopreservation, they should ideally be seen a week before intended sperm cryopreservation. The only requirement besides being healthy enough to come to the clinic, is to have an infectious disease panel drawn then, but prior negative results within a certain time frame may be accepted. In the instance a patient is sick and hospitalized, when deemed appropriate, an authorized party may be allowed to bring the sperm to the facility for cryopreservation from the hospital/ICU.
Building Your Care Team
Making decisions about fertility and clinical trial participation often involves multiple healthcare professionals working together.
Your care team may include:
Your nephrologist
Clinical trial principal investigators (commonly referred to as PIs)
A reproductive endocrinologist (fertility specialist)
A genetic counselor
Your primary care physician
A maternal-fetal medicine specialist, when appropriate
Collaborative care helps ensure your treatment goals and future family-building goals are both considered.
Financial Considerations
Fertility preservation services can represent a significant financial investment, and insurance coverage varies considerably depending on location, diagnosis, and individual insurance plans.
If fertility preservation is recommended before participation in a clinical trial, ask:
What costs should I expect?
Does my insurance provide any coverage?
Are financing options available?
Are there grants that may help?
It is important to note PKD-Free Alliance does not provide financial assistance for elective fertility preservation, including egg, sperm, or embryo freezing. However, for families affected by PKD who are ready to pursue family building, financial assistance may be available to eligible families undergoing IVF with PGT-M through the PKD-Free Babies Grant Program.
Understanding these considerations early allows you to explore available resources before making time-sensitive decisions.
Every Family's Journey Is Different
Choosing whether to participate in a clinical trial and whether to pursue fertility preservation is deeply personal.
For some individuals, preserving fertility before treatment provides reassurance and additional reproductive options in the future. For others, fertility preservation may not be medically indicated, financially feasible, or aligned with their personal goals.
The most important step is having these conversations before treatment begins so you understand your options and can make informed decisions with your healthcare team.
How PKD-Free Alliance Can Help
PKD-Free Alliance is committed to helping individuals and families understand their reproductive options.
We provide:
Educational resources about family planning and inherited kidney disease
Information about IVF and PGT-M
Referrals to reproductive specialists experienced in inherited conditions
Financial assistance for eligible families pursuing IVF with PGT-M through the PKD-Free Babies Grant Program
While the PKD-Free Babies Grant Program does not cover elective egg, sperm, or embryo freezing, eligible families may receive financial assistance for IVF with PGT-M to help reduce the likelihood of passing PKD to their children.
Our goal is not to tell families which path to choose but rather to ensure they have the knowledge and support needed to make informed decisions that are right for them.
Looking Ahead
As research continues to advance, clinical trials remain essential to improving treatments for PKD and other conditions. At the same time, preserving future reproductive options may be an important consideration for many participants.
By discussing fertility preservation before enrolling in a clinical trial, you can better understand your choices, ask informed questions, and make decisions that support both your current health and your long-term family-building goals.
