NCT06826820: InFert

Fertility: Infection and Inflammation

Recruiting now Last updated 14 February 2025

What this trial tests

trial in Observational Study of IVF Patients in 800 participants. Currently enrolling.

Timeline

28 February 2023

Primary endpoint
20 December 2032

20 December 2032

Quick facts

Lead sponsor	Medical University of Graz
Status	Recruiting now
Study type	OBSERVATIONAL
Enrollment	800
Start date	28 February 2023
Primary completion	20 December 2032
Estimated completion	20 December 2032
Sites	1 location across Austria

Conditions studied

• Observational Study of IVF Patients — all drugs for Observational Study of IVF Patients →

Sponsor

Medical University of Graz

Who can join

18 and older, female only, with Observational Study of IVF Patients. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The investigators explore whether inflammatory factors and infections in collected samples are altered in fertility issues and if they can predict pregnancy outcomes. The investigators focus on pro- and anti-inflammatory markers, such as cytokines, metabolic parameters (e.g., blood lipids, hormones, bile acids), and viral infections (e.g., HPV, herpesviruses). A standard blood panel is also performed.

Fertility issues are rising due to aging, infections, environmental toxins, and lifestyle factors (e.g., BMI, diabetes). Fertilization and implantation involve complex interactions between the egg, sperm, embryo, and endometrium, which can be disrupted by inflammatory processes from infections, metabolic imbalances, or environmental toxins. IVF allows access to unique samples that help identify these processes and their impact on fertility.

1. Sample Collection \& Analysis

* Diagnostic Cycle: Blood samples (early/late follicular phase), endometrial sample (7 days post-ovulation), and body composition analysis (BOD POD).
* Oocyte Retrieval: Blood, follicular fluid, vaginal swab, and another body composition analysis (BOD POD). The male partner provides blood and an ejaculate sample.
* After IVF: The culture medium where the fertilized egg grows is collected. Samples are analyzed for hormones, cytokines, metabolites, nucleic acids, proteins, and immune cells. Some granulosa cells are isolated and cultured.
2. Clinical \& Fertility Parameters

The main outcome is a clinical pregnancy, but additional factors are examined:
* Patient: IVF reason, AMH levels, pre-existing conditions, medications, smoking, pregnancy duration.
* IVF parameters: Follicle counts, retrieved oocytes, fertilization method (IVF/ICSI), embryo quality, implantation rate, miscarriage rate, and live birth rate.
* Newborn: Birth weight, length, sex.
3. Control Groups \& Data Management Control groups consist of couples where infertility is attributed to only one partner. All samples are pseudonymized before analysis to ensure data privacy.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Elevated plasma glucose links intrafollicular bile acids to altered embryological outcomes in IVF patients.
   Berger N, Rodriguez-Blanco G, Brugger K, Amtmann B, et al · · 2025 · PMID 41455970 · DOI 10.1186/s13048-025-01939-1