IVFNCT05893238
Human Follicular Fluid Markers and Reproductive Outcomes in IVF
An observational study of IVF and Infertility, run by Janna Pape at 1 site in Switzerland.
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… Read more about this study
- Who is it for?
- Ages 18 to 42 years
- Conditions the study is for
- IVF, Infertility
- What is being tested?
- Natural cycle In Vitro Fertilisation (IVF), Blood samples for analysis and Follicular fluid for analysis
- Type of treatment
- Surgery or procedure
- How many people
- 200 participants
- Where
- 1 siteSwitzerland
- Study dates
- 2 Oct 2023to Jun 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 42 years
- All sexes
- No healthy volunteers
- Adult
Study population: Patients aiming to do In Vitro Fertilisation with fresh embryo transfer
Who may be able to join
- Willing to participate
- Written consent
- Couples undergoing In Vitro Fertilisation (natural cycle or conventional IVF)
Who cannot join
- Not willing to participate
- Missing consent
- Female of the couple does not want to participate or missing consent
- Language barrier
- Medical freezing
- Social freezing
Show all 15Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Switzerland1 site, 1 recruiting
- Recruiting
Inselspital Bern, Frauenklinik
Bern, 3010
Michael von Wolff, Prof., michael.vonWolff@insel.ch
Janna Pape, Dr. med., janna.pape@insel.ch
About this study
Official title: 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.
Read the 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.
- Conditions
- IVF, Infertility
- Being tested
- Natural cycle In Vitro Fertilisation (IVF), Blood samples for analysis, Follicular fluid for analysis, Sperm samples for analysis, Conventional In Vitro Fertilisation (IVF)
- Keywords
- Natural IVF, Follicular Fluid, Oxidation-reduction potential, Gonadotrophin, Lifestyle
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Natural cycle In Vitro Fertilisation (IVF)Procedure or surgery
In Vitro Fertilisation (IVF) without hormonal stimulation
Blood samples for analysisDiagnostic test
Test hormone levels in serum
Follicular fluid for analysisDiagnostic test
Test hormone levels in follicular fluid Test Oxidation-reduction potential
Sperm samples for analysisDiagnostic test
Oxidation-reduction potential
Conventional In Vitro Fertilisation (IVF)Procedure or surgery
In Vitro Fertilisation (IVF) with conventional hormonal stimulation
| Study group | Role | What they receive |
|---|---|---|
| In Vitro Fertilisation (IVF)-Patients without hormonal stimulation (Natural cycle IVF) | Natural cycle IVF Receives: 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 Receives: Diagnostic Test: Blood samples for analysis; Diagnostic Test: Follicular fluid for analysis; Diagnostic Test: Sperm samples for analysis; Procedure: Conventional In Vitro Fertilisation (IVF) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blastocyst rate per oocyte
Number of blastocysts out of fertilized oocytes observed 5 days after fertilization
Measured: 5 days after fertilization
Secondary outcomes (6)
Number of mature oocytes
Number of mature oocytes from punctured follicles
Measured: 4-6 hours after punction
Cleavage rate per oocyte
Number of cleavage embryos out of fertilized oocytes observed 2 days after fertilization
Measured: 2 days after fertilization
Morphologic evaluation of blastocyst
Morphologic evaluation according to the Gardner score (Gardner and Schoolcraft, 1999)
Measured: 5 days after fertilization
Implantation rate
Endocrine pregnancy by measuring hCG in blood sample on day 10-12 after embryo transfer
Measured: 10-12 days after embryo transfer
Clinical pregnancy rate
Clinical pregnancy confirmed by ultrasound, 5 weeks after embryo transfer.
Measured: 5 weeks after embryo transfer
Live birth rate
Birth of a living baby nine months after embryo transfer
Measured: 9 months after embryo transfer
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2023
- Study start2 Oct 2023
- Primary completionJun 2025 (estimated)
- Study completionJun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for IVFStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Janna Pape
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Janna Pape, Universitätsklinik fur Frauenheilkunde, Inselspital Bern
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05893238
- Sponsor's protocol ID
- KEK Bern 2022-00944
- Status last verified
- May 2023
- First submitted
- 18 May 2023
- Last updated
- 29 Nov 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Human Follicular Fluid Markers and Reproductive Outcomes in IVF: Relevant Factors for the Oocyte's Developmental Potential
- ClinicalTrials.gov ID
- NCT05893238
- Acronym / sponsor ID
- KEK Bern 2022-00944
- Conditions
- IVF, Infertility
- Keywords
- Natural IVF, Follicular Fluid, Oxidation-reduction potential, Gonadotrophin, Lifestyle
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Janna PapeUniversity, hospital or other
- Study start
- 2 Oct 2023 (actual)
- Primary completion
- Jun 2025 (estimated)
- Study completion
- Jun 2025 (estimated)
- First posted
- 7 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| In Vitro Fertilisation (IVF)-Patients without hormonal stimulation (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 analysisNatural cycle IVF |
| In Vitro Fertilisation (IVF)-Patients with hormonal stimulation (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)conventional IVF |
Who may qualify
- Ages
- 18 to 42 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Patients aiming to do In Vitro Fertilisation with fresh embryo transfer
Key inclusion criteria (3 listed)
- Willing to participate
- Written consent
- Couples undergoing In Vitro Fertilisation (natural cycle or conventional IVF)
Key exclusion criteria (15 listed)
- Not willing to participate
- Missing consent
- Female of the couple does not want to participate or missing consent
- Language barrier
- Medical freezing
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Natural cycle In Vitro Fertilisation (IVF)In Vitro Fertilisation (IVF) without hormonal stimulation | Procedure or surgery | In Vitro Fertilisation (IVF)-Patients without hormonal stimulation (Natural cycle IVF) |
| Blood samples for analysisTest hormone levels in serum | Diagnostic test | In Vitro Fertilisation (IVF)-Patients with hormonal stimulation (conventional IVF), In Vitro Fertilisation (IVF)-Patients without hormonal stimulation (Natural cycle IVF) |
| Follicular fluid for analysisTest hormone levels in follicular fluid Test Oxidation-reduction potential | Diagnostic test | In Vitro Fertilisation (IVF)-Patients with hormonal stimulation (conventional IVF), In Vitro Fertilisation (IVF)-Patients without hormonal stimulation (Natural cycle IVF) |
| Sperm samples for analysisOxidation-reduction potential | Diagnostic test | 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)In Vitro Fertilisation (IVF) with conventional hormonal stimulation | Procedure or surgery | In Vitro Fertilisation (IVF)-Patients with hormonal stimulation (conventional IVF) |
Primary outcome
Blastocyst rate per oocyte
Time frame: 5 days after fertilization
Number of blastocysts out of fertilized oocytes observed 5 days after fertilization
6 secondary outcomes
Number of mature oocytes
Time frame: 4-6 hours after punction
Cleavage rate per oocyte
Time frame: 2 days after fertilization
Morphologic evaluation of blastocyst
Time frame: 5 days after fertilization
Implantation rate
Time frame: 10-12 days after embryo transfer
Clinical pregnancy rate
Time frame: 5 weeks after embryo transfer
Live birth rate
Time frame: 9 months after embryo transfer
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of IVF and Infertility, run by Janna Pape at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Janna Pape, MD (0041316321010, janna.pape@insel.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blastocyst rate per oocyte (time frame: 5 days after fertilization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Nov 2023.