Human Follicular Fluid Markers and Reproductive Outcomes in IVF

NCT ID: NCT05893238

Last Updated: 2023-11-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-10-02

Study Completion Date

2025-06-30

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.

Conditions

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IVF Infertility

Keywords

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Natural IVF Follicular Fluid Oxidation-reduction potential Gonadotrophin Lifestyle

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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

Natural cycle IVF

Natural cycle In Vitro Fertilisation (IVF)

Intervention Type PROCEDURE

In Vitro Fertilisation (IVF) without hormonal stimulation

Blood samples for analysis

Intervention Type DIAGNOSTIC_TEST

Test hormone levels in serum

Follicular fluid for analysis

Intervention Type DIAGNOSTIC_TEST

Test hormone levels in follicular fluid Test Oxidation-reduction potential

Sperm samples for analysis

Intervention Type DIAGNOSTIC_TEST

Oxidation-reduction potential

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

conventional IVF

Blood samples for analysis

Intervention Type DIAGNOSTIC_TEST

Test hormone levels in serum

Follicular fluid for analysis

Intervention Type DIAGNOSTIC_TEST

Test hormone levels in follicular fluid Test Oxidation-reduction potential

Sperm samples for analysis

Intervention Type DIAGNOSTIC_TEST

Oxidation-reduction potential

Conventional In Vitro Fertilisation (IVF)

Intervention Type PROCEDURE

In Vitro Fertilisation (IVF) with conventional hormonal stimulation

Interventions

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Natural cycle In Vitro Fertilisation (IVF)

In Vitro Fertilisation (IVF) without hormonal stimulation

Intervention Type PROCEDURE

Blood samples for analysis

Test hormone levels in serum

Intervention Type DIAGNOSTIC_TEST

Follicular fluid for analysis

Test hormone levels in follicular fluid Test Oxidation-reduction potential

Intervention Type DIAGNOSTIC_TEST

Sperm samples for analysis

Oxidation-reduction potential

Intervention Type DIAGNOSTIC_TEST

Conventional In Vitro Fertilisation (IVF)

In Vitro Fertilisation (IVF) with conventional hormonal stimulation

Intervention Type PROCEDURE

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

42 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Janna Pape

OTHER

Sponsor Role lead

Responsible Party

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Janna Pape

Principal Investigator, Senior doctor, Janna Pape (MD)

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Inselspital Bern, Frauenklinik

Bern, , Switzerland

Site Status RECRUITING

Countries

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Switzerland

Central Contacts

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Janna Pape, MD

Role: CONTACT

Phone: 0041316321010

Email: [email protected]

Michael von Wolff, Prof. Dr.

Role: CONTACT

Phone: 0041316321301

Email: [email protected]

Facility Contacts

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Michael von Wolff, Prof.

Role: primary

Janna Pape, Dr. med.

Role: backup

Other Identifiers

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KEK Bern 2022-00944

Identifier Type: -

Identifier Source: org_study_id