Human Follicular Fluid Markers and Reproductive Outcomes in IVF

Recruiting

• Conditions: IVF; Infertility
• Interventions: Diagnostic Test: Blood samples for analysis; Procedure: Natural cycle In Vitro Fertilisation (IVF); Diagnostic Test: Follicular fluid for analysis; Procedure: Conventional In Vitro Fertilisation (IVF); Diagnostic Test: Sperm samples for analysis

• Registration Number: NCT05893238
• Lead Sponsor: Janna Pape

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 Timeline

• Status Verified: 2023-05
• Study First Submitted: 2023-05-18
• Study First Submitted QC: 2023-05-30
• Study First Posted: 2023-06-07
• Study Start: 2023-10-02
• Last Update Submitted: 2023-11-28
• Last Update Posted: 2023-11-29
• Primary Completion: 2025-06
• Study Completion: 2025-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
In Vitro Fertilisation (IVF)-Patients with hormonal stimulation (conventional IVF)	Blood samples for analysis	conventional IVF
In Vitro Fertilisation (IVF)-Patients without hormonal stimulation (Natural cycle IVF)	Blood samples for analysis	Natural cycle IVF
In Vitro Fertilisation (IVF)-Patients with hormonal stimulation (conventional IVF)	Conventional In Vitro Fertilisation (IVF)	conventional IVF
In Vitro Fertilisation (IVF)-Patients without hormonal stimulation (Natural cycle IVF)	Natural cycle In Vitro Fertilisation (IVF)	Natural cycle IVF
In Vitro Fertilisation (IVF)-Patients without hormonal stimulation (Natural cycle IVF)	Follicular fluid for analysis	Natural cycle IVF
In Vitro Fertilisation (IVF)-Patients without hormonal stimulation (Natural cycle IVF)	Sperm samples for analysis	Natural cycle IVF
In Vitro Fertilisation (IVF)-Patients with hormonal stimulation (conventional IVF)	Follicular fluid for analysis	conventional IVF
In Vitro Fertilisation (IVF)-Patients with hormonal stimulation (conventional IVF)	Sperm samples for analysis	conventional IVF

Primary Outcome Measures

Name	Time	Method
Blastocyst rate per oocyte	5 days after fertilization	Number of blastocysts out of fertilized oocytes observed 5 days after fertilization

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Inselspital Bern, Frauenklinik; 🇨🇭 Bern, Switzerland