Human Follicular Fluid Markers and Reproductive Outcomes in IVF

NCT05893238 | Unknown

• 1 other identifier: KEK Bern 2022-00944
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

IVF; Infertility

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Blastocyst rate per oocyte

  Number of blastocysts out of fertilized oocytes observed 5 days after fertilization

  5 days after fertilization

Secondary Outcomes (6)

• Number of mature oocytes

  4-6 hours after punction

• Cleavage rate per oocyte

  2 days after fertilization

• Morphologic evaluation of blastocyst

  5 days after fertilization

• Implantation rate

  10-12 days after embryo transfer

• Clinical pregnancy rate

  5 weeks after embryo transfer

Study Arms (2)

In Vitro Fertilisation (IVF)-Patients without hormonal stimulation (Natural cycle IVF)

Natural cycle IVF

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

In Vitro Fertilisation (IVF)-Patients with hormonal stimulation (conventional IVF)

conventional 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)

Interventions

Natural cycle In Vitro Fertilisation (IVF) PROCEDURE

In Vitro Fertilisation (IVF) without hormonal stimulation

In Vitro Fertilisation (IVF)-Patients without hormonal stimulation (Natural cycle IVF)

Blood samples for analysis DIAGNOSTIC_TEST

Test hormone levels in serum

In Vitro Fertilisation (IVF)-Patients with hormonal stimulation (conventional IVF); In Vitro Fertilisation (IVF)-Patients without hormonal stimulation (Natural cycle IVF)

Follicular fluid for analysis DIAGNOSTIC_TEST

Test hormone levels in follicular fluid Test Oxidation-reduction potential

In Vitro Fertilisation (IVF)-Patients with hormonal stimulation (conventional IVF); In Vitro Fertilisation (IVF)-Patients without hormonal stimulation (Natural cycle IVF)

Sperm samples for analysis DIAGNOSTIC_TEST

Oxidation-reduction potential

In Vitro Fertilisation (IVF)-Patients with hormonal stimulation (conventional IVF); In Vitro Fertilisation (IVF)-Patients without hormonal stimulation (Natural cycle IVF)

Conventional In Vitro Fertilisation (IVF) PROCEDURE

In Vitro Fertilisation (IVF) with conventional hormonal stimulation

In Vitro Fertilisation (IVF)-Patients with hormonal stimulation (conventional IVF)

Eligibility Criteria

• Age: 18 Years - 42 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Patients aiming to do In Vitro Fertilisation with fresh embryo transfer

You may qualify if:

• Willing to participate
• Written consent
• Couples undergoing In Vitro Fertilisation (natural cycle or conventional IVF)

You may not qualify if:

• 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

Sponsors & Collaborators

• Janna Pape: lead

Study Sites (1)

Inselspital Bern, Frauenklinik

Bern, 3010, Switzerland

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Follicular fluid; serum

MeSH Terms

Conditions

Infertility

Interventions

Blood Specimen Collection; Congresses as Topic

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques; Organizations; Health Care Economics and Organizations

Central Study Contacts

Janna Pape, MD

CONTACT

0041316321010; janna.pape@insel.ch

Michael von Wolff, Prof. Dr.

CONTACT

0041316321301; michael.vonwolff@insel.ch

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator, Senior doctor, Janna Pape (MD)

Study Record Dates

• First Submitted: May 18, 2023
• First Posted: June 7, 2023
• Study Start: October 2, 2023
• Primary Completion: June 1, 2025
• Study Completion: June 1, 2025
• Last Updated: November 29, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)