Human Follicular Fluid Markers and Reproductive Outcomes in IVF

November 28, 2023 updated by: Janna Pape

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients aiming to do In Vitro Fertilisation with fresh embryo transfer

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
In Vitro Fertilisation (IVF)-Patients without hormonal stimulation (Natural cycle IVF)
Natural cycle IVF
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
Diagnostic test: Follicular fluid for analysis
Test hormone levels in follicular fluid Test Oxidation-reduction potential
Diagnostic test: Sperm samples for analysis
Oxidation-reduction potential
In Vitro Fertilisation (IVF)-Patients with hormonal stimulation (conventional IVF)
conventional IVF
Diagnostic test: Blood samples for analysis
Test hormone levels in serum
Diagnostic test: Follicular fluid for analysis
Test hormone levels in follicular fluid Test Oxidation-reduction potential
Diagnostic test: Sperm samples for analysis
Oxidation-reduction potential
Procedure: Conventional In Vitro Fertilisation (IVF)
In Vitro Fertilisation (IVF) with conventional hormonal stimulation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Blastocyst rate per oocyte
Time Frame: 5 days after fertilization
Number of blastocysts out of fertilized oocytes observed 5 days after fertilization
5 days after fertilization

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Janna Pape

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 2, 2023

Primary Completion (Estimated)

June 1, 2025

Study Completion (Estimated)

June 1, 2025

Study Registration Dates

First Submitted

May 18, 2023

First Submitted That Met QC Criteria

May 30, 2023

First Posted (Actual)

June 7, 2023

Study Record Updates

Last Update Posted (Actual)

November 29, 2023

Last Update Submitted That Met QC Criteria

November 28, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KEK Bern 2022-00944

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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