Human Follicular Fluid Markers and Reproductive Outcomes in IVF

Study Overview
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Brief Summary
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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
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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.

Official Title
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Human Follicular Fluid Markers and Reproductive Outcomes in IVF: Relevant Factors for the Oocyte's Developmental Potential

Conditions
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IVF, Infertility

Intervention / Treatment
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* Procedure: Natural cycle In Vitro Fertilisation (IVF)
* Diagnostic Test: Blood samples for analysis
* Diagnostic Test: Follicular fluid for analysis
* Diagnostic Test: Sperm samples for analysis
* Procedure: Conventional In Vitro Fertilisation (IVF)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 42 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| In Vitro Fertilisation (IVF)-Patients without hormonal stimulation (Natural cycle IVF)<br>Natural cycle IVF | Procedure: Natural cycle In Vitro Fertilisation (IVF)<br>* In Vitro Fertilisation (IVF) without hormonal stimulation<br>Diagnostic Test: Blood samples for analysis<br>* Test hormone levels in serum<br>Diagnostic Test: Follicular fluid for analysis<br>* Test hormone levels in follicular fluid Test Oxidation-reduction potential<br>Diagnostic Test: Sperm samples for analysis<br>* Oxidation-reduction potential<br>|
| In Vitro Fertilisation (IVF)-Patients with hormonal stimulation (conventional IVF)<br>conventional IVF | Diagnostic Test: Blood samples for analysis<br>* Test hormone levels in serum<br>Diagnostic Test: Follicular fluid for analysis<br>* Test hormone levels in follicular fluid Test Oxidation-reduction potential<br>Diagnostic Test: Sperm samples for analysis<br>* Oxidation-reduction potential<br>Procedure: Conventional In Vitro Fertilisation (IVF)<br>* In Vitro Fertilisation (IVF) with conventional hormonal stimulation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blastocyst rate per oocyte | Number of blastocysts out of fertilized oocytes observed 5 days after fertilization | 5 days after fertilization | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of mature oocytes | Number of mature oocytes from punctured follicles | 4-6 hours after punction | 
| Cleavage rate per oocyte | Number of cleavage embryos out of fertilized oocytes observed 2 days after fertilization | 2 days after fertilization | 
| Morphologic evaluation of blastocyst | Morphologic evaluation according to the Gardner score (Gardner and Schoolcraft, 1999) | 5 days after fertilization | 
| Implantation rate | Endocrine pregnancy by measuring hCG in blood sample on day 10-12 after embryo transfer | 10-12 days after embryo transfer | 
| Clinical pregnancy rate | Clinical pregnancy confirmed by ultrasound, 5 weeks after embryo transfer. | 5 weeks after embryo transfer | 
| Live birth rate | Birth of a living baby nine months after embryo transfer | 9 months after embryo transfer | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Natural IVF, Follicular Fluid, Oxidation-reduction potential, Gonadotrophin, Lifestyle