None listed
Conditions
Brief summary
IVF remains a difficult process – physically and emotionally - in part due to the ovarian stimulation protocols that stimulate the ovaries. It has been established that there is crosstalk between female gonadal hormones and the vaginal microbiome. This research aims to look at how the vaginal microbiome will respond when exposed to the physiologically abnormal doses of reproductive hormones introduced during Assisted Reproductive Technology treatment. The purpose of this project is to investigate whether fertility treatment used to stimulate ovulation, changes the amount, or type, of microbes usually present in your vaginal microbiome. This study wants to know what a person's vaginal microbiome looks like prior to commencing gonadotropin fertility treatment, during treatment, and once the person has finished treatment.
Interventions
To determine if there are detectable changes across the vaginal microbiome in patients undergoing gonadotropin therapy as part of their Assisted Reproductive Technology journey, from pre-exposure to the medication prior to treatment, to the end of treatment at embryo transfer.
Data collected from participants includes:
• Provide vaginal swabs at 3 timepoints (Enrolment, Egg Collection & Embryo Transfer). . 3 x lower vaginal swabs will be self-collected by the participant (an education sheet and
To determine if there are detectable changes across the vaginal microbiome in patients undergoing gonadotropin therapy as part of their Assisted Reproductive Technology journey, from pre-exposure to the medication prior to treatment, to the end of treatment at embryo transfer. Data collected from participants includes: • Provide vaginal swabs at 3 timepoints (Enrolment, Egg Collection & Embryo Transfer). . 3 x lower vaginal swabs will be self-collected by the participant (an education sheet and video is provided for this), and 2 x high-vaginal swabs will be collected by a trained health professional at the time of egg collection and embryo transfer. • Provide personal history such as date of birth, ethnicity, sexual orientation, relationship status • Provide information on your menstrual cycle history (date of last menstrual period, regular/irregular, length of cycle) • Provide information on past and current medical/surgical history • Provide information on current medications used, and medications used throughout your participation. This will also include gonadotropin dose and schedule once prescribed • Undertake a small physical examination including vital signs (temperature, blood pressure, heart rate, respiratory rate), height, weight, BMI, body composition and waist circumference. • Answer a small questionnaire on environmental exposures including smoking, alcohol, illicit drug use, caffeine use, pets & animals/livestock, and sleep quality All of this information is collected as it has been documented to impact on the composition of a person's microbiome. You will be involved in this project for approximately 4 months.
Sponsors
University of New South Wales
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
• Women undergoing Assisted Reproductive Technology • 18 or older • Agree to adhere to all protocol requirements. • Provide written informed consent
Exclusion criteria
• < 18 years of age • Oncology patients undergoing fertility treatments • History of recurrent miscarriage • Already pregnant • Premature ovarian insufficiency/failure • Currently on Antibiotic therapy or have taken in the 3 months prior to enrolment • Highly dependent on medical care by virtue of major pre-existing mental and/or physical disabilities • Require interpreter services for either her usual care or to understand the study information will not be recruited
Outcome results
None listed