Human Follicular Fluid Markers and Reproductive Outcomes in IVF

• Sponsor: Janna Pape (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05893238
• Collaborator: (none)
• Enrollment: 200
• Anticipated Duration (Months): 24

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
IVF; Infertility	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; Procedure: Conventional In Vitro Fertilisation (IVF)

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

• Study Type: Observational
• Anticipated Enrollment: 200 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Human Follicular Fluid Markers and Reproductive Outcomes in IVF: Relevant Factors for the Oocyte's Developmental Potential
• Anticipated Study Start Date: Jun 1, 2023
• Anticipated Primary Completion Date: Jun 1, 2025
• Anticipated Study Completion Date: Jun 1, 2025

Arms and Interventions

Arm	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

Outcome Measures

Primary Outcome Measures

1. Blastocyst rate per oocyte [5 days after fertilization]

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

Secondary Outcome Measures

1. Number of mature oocytes [4-6 hours after punction]

   Number of mature oocytes from punctured follicles

2. Cleavage rate per oocyte [2 days after fertilization]

   Number of cleavage embryos out of fertilized oocytes observed 2 days after fertilization

3. Morphologic evaluation of blastocyst [5 days after fertilization]

   Morphologic evaluation according to the Gardner score (Gardner and Schoolcraft, 1999)

4. Implantation rate [10-12 days after embryo transfer]

   Endocrine pregnancy by measuring hCG in blood sample on day 10-12 after embryo transfer

5. Clinical pregnancy rate [5 weeks after embryo transfer]

   Clinical pregnancy confirmed by ultrasound, 5 weeks after embryo transfer.

6. Live birth rate [9 months after embryo transfer]

   Birth of a living baby nine months after embryo transfer

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 42 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Janna Pape

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Janna Pape, Principal Investigator, Senior doctor, Janna Pape (MD), Universitätsklinik fur Frauenheilkunde, Inselspital Bern
• ClinicalTrials.gov Identifier: NCT05893238
• Other Study ID Numbers: KEK Bern 2022-00944
• First Posted: Jun 7, 2023
• Last Update Posted: Jun 7, 2023
• Last Verified: May 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Janna Pape, Principal Investigator, Senior doctor, Janna Pape (MD), Universitätsklinik fur Frauenheilkunde, Inselspital Bern: Natural IVF; Follicular Fluid; Oxidation-reduction potential; Gonadotrophin; Lifestyle
• Additional relevant MeSH terms: Infertility

Study Results

No Results Posted as of Jun 7, 2023