None listed
Conditions
Brief summary
One cause of unsuccessful implantation of high-quality embryos during IVF treatment is inadequate endometrial production of the beneficial cytokines LIF and VEGF, both known to assist embryo development and attachment. Our hypothesis, based on positive results from preliminary in vitro experiments, is that application of a copper containing gel to the uterine cavity before ovulation will upregulate the endometrium’s production of LIF and VEGF around the time of a later embryo transfer, thereby augmenting implantation success. The primary objective of this study is to determine the optimal dose of copper for up-regulation of endometrial LIF/VEGF without causing any safety concerns for the study participants. Secondary study outcomes include assessment of uterine fluid copper content and the influence of this fluid on embryo (mouse) development in vitro.
Interventions
In the first experimental phase participants receive a single application of the control gel. After a “wash-out” period of one month and one menstrual period, the same participants will receive a single dose of the active trial medication, copper chloride 100 uM (first four participants) or 200 uM (last four participants, if no severe adverse advents have been reported for the use of 100 uM) suspended in gel (ExEm Gel, ARTG identifier 207276) , to the uterine cavity in the late proliferative pha
In the first experimental phase participants receive a single application of the control gel. After a “wash-out” period of one month and one menstrual period, the same participants will receive a single dose of the active trial medication, copper chloride 100 uM (first four participants) or 200 uM (last four participants, if no severe adverse advents have been reported for the use of 100 uM) suspended in gel (ExEm Gel, ARTG identifier 207276) , to the uterine cavity in the late proliferative phase of the menstrual cycle. The gel (both control and CuCl2) will be applied by the PI of the study.
Sponsors
Flinders University
Study design
Allocation
Non-randomised trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 42 Years
Healthy volunteers
Yes
Inclusion criteria
• Woman between 18 and 42 years old • BMI between 19 and 29 kg/m2 • Regular menstrual cycle every 26-32 days • Normal “baseline” pelvic ultrasound • Normal pap smear and STD screen • Written and signed informed consent
Exclusion criteria
• inflammatory condition requiring systemic treatments (e.g. corticosteroids, NSAID) or acute infection (virus etc). • medical contraindications to the combined contraceptive pill (focal migraine, DVT, smoke > 10/day, BP> 135/85, past adverse response COCP) • known allergy to metals (copper, bronze and nickel especially) • Past surgery to the cervix (LLETZ, cone biopsy) • Past difficult embryo transfer, thereby increasing the risk of a difficult or impossible endometrial biopsy. • Pregnancy or wishing to attempt pregnancy in the next 3 months. • History of undiagnosed abnormal uterine bleeding or chronic pelvic pain. • History of significant menstrual pain or heavy bleeding • Recent abnormal cervical cytology/ high risk HPV screen • Abnormal renal or liver function tests, inflammatory markers (WCC, CRP) and serum copper/ ceruloplasmin • Contraindication to the use of copper (Wilsons Disease, allergy copper). • Unwilling to use barrier contraception or abstain during the study menstrual cycle (in the absence of tubal ligation or partner with vasectomy).
Outcome results
None listed