Clinical trial NCT05893238: Human Follicular Fluid Markers and Reproductive Outcomes in IVF
Official title: Human Follicular Fluid Markers and Reproductive Outcomes in IVF: Relevant Factors for the Oocyte's Developmental Potential
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: IVF
Infertility
Keywords: Natural IVF
Follicular Fluid
Oxidation-reduction potential
Gonadotrophin
Lifestyle
Lead sponsor: Universitätsklinik fur Frauenheilkunde, Inselspital Bern
Sponsor class: OTHER
First posted: 2023-06-07
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 42
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients aiming to do In Vitro Fertilisation with fresh embryo transfer

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.

Eligibility criteria: 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

Primary outcomes:
measure: Blastocyst rate per oocyte
timeFrame: 5 days after fertilization
Secondary outcomes:
measure: Number of mature oocytes
timeFrame: 4-6 hours after punction
measure: Cleavage rate per oocyte
timeFrame: 2 days after fertilization
measure: Morphologic evaluation of blastocyst
timeFrame: 5 days after fertilization
measure: Implantation rate
timeFrame: 10-12 days after embryo transfer
measure: Clinical pregnancy rate
timeFrame: 5 weeks after embryo transfer
measure: Live birth rate
timeFrame: 9 months after embryo transfer
Other outcomes:
Locations:
city: Bern
country: Switzerland
facility: Inselspital Bern, Frauenklinik
Study officials:
References: