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Human Follicular Fluid Markers and Reproductive Outcomes in IVF

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05893238
Enrollment
200
Registered
2023-06-07
Start date
2023-10-02
Completion date
2025-06-30
Last updated
2023-11-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infertility, IVF

Keywords

Natural IVF, Follicular Fluid, Oxidation-reduction potential, Gonadotrophin, Lifestyle

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.

Interventions

PROCEDURENatural cycle In Vitro Fertilisation (IVF)

In Vitro Fertilisation (IVF) without hormonal stimulation

Test hormone levels in serum

DIAGNOSTIC_TESTFollicular fluid for analysis

Test hormone levels in follicular fluid Test Oxidation-reduction potential

Oxidation-reduction potential

PROCEDUREConventional In Vitro Fertilisation (IVF)

In Vitro Fertilisation (IVF) with conventional hormonal stimulation

Sponsors

Janna Pape
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 42 Years
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

Design outcomes

Primary

MeasureTime frameDescription
Blastocyst rate per oocyte5 days after fertilizationNumber of blastocysts out of fertilized oocytes observed 5 days after fertilization

Secondary

MeasureTime frameDescription
Cleavage rate per oocyte2 days after fertilizationNumber of cleavage embryos out of fertilized oocytes observed 2 days after fertilization
Morphologic evaluation of blastocyst5 days after fertilizationMorphologic evaluation according to the Gardner score (Gardner and Schoolcraft, 1999)
Number of mature oocytes4-6 hours after punctionNumber of mature oocytes from punctured follicles
Clinical pregnancy rate5 weeks after embryo transferClinical pregnancy confirmed by ultrasound, 5 weeks after embryo transfer.
Live birth rate9 months after embryo transferBirth of a living baby nine months after embryo transfer
Implantation rate10-12 days after embryo transferEndocrine pregnancy by measuring hCG in blood sample on day 10-12 after embryo transfer

Countries

Switzerland

Contacts

Primary ContactJanna Pape, MD
janna.pape@insel.ch0041316321010
Backup ContactMichael von Wolff, Prof. Dr.
michael.vonwolff@insel.ch0041316321301

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026