Human Follicular Fluid Markers and Reproductive Outcomes in IVF: Relevant Factors for the Oocyte's Developmental Potential
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 200
- Locations
- 1
- Primary Endpoint
- Blastocyst rate per oocyte
Study Overview
Brief Summary
The goal of this observational study is to understand the processes in the growing follicles development in more detail and to improve In Vitro Fertilisation (IVF) treatments. This involves measuring laboratory values in the blood, in the follicular fluid of the woman and in the sperm of the man as well as questionnaires concerning lifestyle factors. These values are then linked to the success of the fertility treatment to find out which of these values increase the success of the IVF treatment.
Furthermore, the investigators want to investigate if there are differences between IVF treatments with or without hormonal stimulation of the ovaries.
Detailed Description
This is a one-site prospective exploratory study at the University Clinic for Gynaecological Endocrinology and Reproductive Medicine in Bern. Data of influencing factors on IVF success in women and men will be collected in two types of IVF treatment, i.e. with or without hormonal stimulation of the ovaries.
The investigators want to
- compare the follicular fluid values between the two IVF treatment groups.
- assess the associations and predictive power of follicular fluid / blood and sperm parameters for success of the IVF treatment.
- compare the IVF success in the two treatment groups. The study aims to enrol approximately 200 couples. The data will be collected by the physicians and added to the REDcap study registry. Access to the total data set is only permitted for the principal investigator.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to 42 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Willing to participate
- •Written consent
- •Couples undergoing In Vitro Fertilisation (natural cycle or conventional IVF)
Exclusion Criteria
- •Not willing to participate
- •Missing consent
- •Female of the couple does not want to participate or missing consent
- •Language barrier
- •Medical freezing
- •Social freezing
- •Thawed cycles
- •Genetic disorders
- •Preimplantation genetic testing (PGT)
- •Medication for chronic condition
- •Surgery in the last 4 weeks
- •Significant trauma in the last 90 days
- •Severe reduced sperm quality
- •Kryosperm
- •Poor responder or expected poor response
Outcomes
Primary Outcomes
Blastocyst rate per oocyte
Time Frame: 5 days after fertilization
Number of blastocysts out of fertilized oocytes observed 5 days after fertilization
Secondary Outcomes
- Live birth rate(9 months after embryo transfer)
- Cleavage rate per oocyte(2 days after fertilization)
- Morphologic evaluation of blastocyst(5 days after fertilization)
- Number of mature oocytes(4-6 hours after punction)
- Implantation rate(10-12 days after embryo transfer)
- Clinical pregnancy rate(5 weeks after embryo transfer)
Investigators
Janna Pape
Principal Investigator, Senior doctor, Janna Pape (MD)
Universitätsklinik fur Frauenheilkunde, Inselspital Bern