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The age-dependent influence of the microbiome, metabolome and oral health on the outcome of assisted reproductive medical treatment (AROMA)

The age-dependent influence of the microbiome, metabolome and oral health on the outcome of assisted reproductive medical treatment (AROMA) - AROMA

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
DRKS
Registry ID
DRKS00034015
Enrollment
1000
Registered
2024-06-17
Start date
2024-01-01
Completion date
Unknown
Last updated
2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Z31

Interventions

Group 1: Patients with an indication for ART During ovarian hyperstimulation, dental examination and sampling of oral plaques for microbiome analysis, as well as blood sampling for metabolome analyses

Sponsors

Univeristitätsklinikum Heidelberg
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 50 Years

Inclusion criteria

Inclusion criteria: • Capacity to consent - Signed declaration of consent and consent to the data protection regulations - No contraindication for clinical-dental probing to determine the periodontal status (Z.n. endocarditis, immunosuppression, Z.n. radiotherapy in the head and neck area) - No known general diseases that could have an influence on the oral microbiome

Exclusion criteria

Exclusion criteria: -Existing pregnancy - Immunosuppressive therapy - Taking medication that can have an effect on (gingival) inflammation - Presence of a serious general illness including illnesses with a high risk of endocarditis, immunosuppression and existing infectious diseases (e.g. HIV) - Non-compliance with the study-related requirements (oral hygiene in the last 12 hours before sample collection) - vaginal infections - acute infections

Design outcomes

Primary

MeasureTime frame
The target criteria are differences in the oral and vaginal microbiome and metabolome in women with successful ART (pregnancy) compared to unsuccessful ART. 14 days after follicular puncture, ßHCG is determined from the blood. Pregnancy exists if a positive cardiac action is detected on ultrasound.

Secondary

MeasureTime frame
Live births only in direct connection with the ART cycle under investigation

Countries

Germany

Contacts

Public ContactSabine Keß

Universitätsfrauenklink Heidelberg

Kinderwunsch.FRAU@med.uni-heidelberg.06221 56 7910

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026