Human Follicular Fluid Markers and Reproductive Outcomes in IVF

Infertility Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05893238
• Other study ID #: KEK Bern 2022-00944
• Status: Recruiting
• Start date: October 2, 2023
• Est. completion date: June 2025

Study information

• Verified date: May 2023
• Source: Universitätsklinik fur Frauenheilkunde, Inselspital Bern
• Contact: Janna Pape, MD
• Phone: 0041316321010
• Email: janna.pape[@]insel.ch
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: June 2025
• Est. primary completion date: June 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 42 Years

Eligibility

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

Related Conditions & MeSH terms

• Infertility
• IVF

Intervention

Procedure:
• Natural cycle In Vitro Fertilisation (IVF)
In Vitro Fertilisation (IVF) without hormonal stimulation

Diagnostic Test:
• Blood samples for analysis
Test hormone levels in serum
• Follicular fluid for analysis
Test hormone levels in follicular fluid Test Oxidation-reduction potential
• Sperm samples for analysis
Oxidation-reduction potential

Procedure:
• Conventional In Vitro Fertilisation (IVF)
In Vitro Fertilisation (IVF) with conventional hormonal stimulation

Locations

Country	Name	City	State
Switzerland	Inselspital Bern, Frauenklinik	Bern

Sponsors (1)

Lead Sponsor	Collaborator
Janna Pape

Country where clinical trial is conducted

Switzerland, 

Outcome

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