What is expected of us?

During your initial visit at Heartland Fertility Clinic, couples eligible for the study will be informed that they may qualify. If you are interested and eligible, our study nurse will contact you to provide more information on how the study works and what would be asked of you both to participate. On your next visit to the clinic, the study nurse will meet with you in person. They will provide the consent forms and explained any questions you may have.

After signing the consent form, you will have your normal fertility visit. The study nurse will coordinate with the clinic team to have your fertility exam conducted with the addition of research sample collections on the same visit.

Female samples that can be expected are a urine sample, uterine swabs, vaginal swabs, rectal swab, a vaginal wash sample, and blood draw. Lastly, a biopsy will be taken in a similar manner as the ERA biopsy sometimes performed during fertility treatments. 

Male samples that can be expected are a urine sample, penile swabs taken from different areas on the penis, and a seminal fluid sample.

You both will also be asked to fill out a questionnaire to collect various qualities of your couple. This includes items like demographics, age, smoking/substance use, medical history, sexual practices, past pregnancies, birth control use and other information that may influence your reproductive health and microbiome. These questionnaires will be provided to you during your initial study visit, and can be either filled out in the clinic, or brought home to be filled out. Completed questionnaires can be provided to the study nurse whenever the next scheduled clinic visit is. 

You will also be instructed on how to use an online food diary, which will collect information about your diet using the online ASA24 dietary tool. You will be provided login information using an ID code specific to each participant that cannot be used for personal identification to maintain anonymity but will be linked to their clinical samples and questionnaire answers. Dietary information will be collected as a 24-hour food recall from a day close to the day of sample collection. Any questions the participants have on these questionnaires will be answered by the study research nurses who will be on hand if needed. 

Follow up visits:

Participants who go through one cycle of IVF but are unsuccessful, and are moving forward with another IVF cycle, will be asked to collect the same samples again. This is optional and will be confirmed with participants at the follow-up visit.

Thank you very much for considering to participate in the THRIVE FERTILITY study!