Global Medicare · Ovarian Research

ExoRegenOvo

Study 02-REGEN-AR

A prospective observational study comparing clinical and reproductive outcomes associated with two autologous PRP preparation approaches used within routine ovarian fertility care at IVF Baden-Baden.

Prospective Observational IVF Baden-Baden

Participation in the study is separate from clinical care. Treatment selection and final research eligibility belong to the authorised medical and research teams.

Study overview

ExoRegenOvo at a glance.

02-REGEN-AR is the ovarian observational study conducted at IVF Baden-Baden under the direction of Prof. Dr. med. Wolfgang Küpker.

0 planned participants
52 / 52 Standard-PRP / IAS
30–47 years · general study population
≤3 stimulation cycles observed

Primary research question

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Does the number of transferable embryos differ between patients receiving Standard-PRP and IAS within routine care?

The primary study objective is to compare the total number of transferable embryos obtained during a treatment sequence of up to three ovarian stimulation cycles.

The study does not assign Standard-PRP or IAS. The preparation is selected independently within clinical care.

Study design

Designed to observe routine clinical care, not assign it.

02-REGEN-AR documents ovarian and reproductive outcomes prospectively in patients already receiving one of two autologous preparation approaches within their clinical pathway.

01 Prospective

Study information is documented forward in time.

02 Observational

Research observes routine care rather than assigning treatment.

03 Single-centre

The study is conducted at IVF Baden-Baden.

04 Non-randomised

Standard-PRP and IAS are not assigned randomly by the study.

Study population

An ovarian-factor IVF / ICSI population.

The general study population consists of women aged 30 to 47 years with ovarian-factor concerns relevant to the protocol.

These are general study profiles, not an online eligibility checklist. The protocol includes additional clinical and laboratory criteria that must be reviewed by the authorised team.

01 Reduced ovarian reserve Reduced ovarian reserve according to POSEIDON groups I–IV is one of the principal study profiles.
02 Advanced maternal age Women aged 40–47 years form another ovarian-factor profile described by the protocol.
03 PCOS PCOS diagnosed according to Rotterdam criteria is represented within the study population.
04 Broader medical assessment Final assessment also considers medical history, laboratory findings and other inclusion and exclusion criteria.

Observation pathway

Up to three stimulation cycles may form part of the treatment sequence.

The actual number of cycles depends on the individual clinical course. Standard-PRP or IAS can be administered during the first and second retrievals; neither preparation is administered during the optional third retrieval.

CYCLE 01 First stimulation & retrieval

Clinical stimulation, retrieval, IVF / ICSI laboratory outcomes and intraovarian Standard-PRP or IAS within routine care.

CYCLE 02 Second stimulation & retrieval

A second treatment cycle can be undertaken according to the individual clinical course, again with Standard-PRP or IAS.

CYCLE 03 · OPTIONAL Third stimulation & retrieval

If clinically required, a third cycle can be performed. No PRP or IAS is administered during the third retrieval.

The clinical pathway determines whether two or three cycles are performed; the research protocol does not require an unnecessary third cycle.

Study outcomes

The primary endpoint is accompanied by multiple secondary parameters.

IVF laboratory, ovarian, clinical and safety information can be documented within the observational framework.

PRIMARY Transferable embryos

Total number of transferable embryos obtained by the end of the treatment sequence.

IVF LAB Oocytes & embryos

Mature MII oocytes, embryo number, transferable embryos and embryo quality.

OVARIAN AMH & AFC

Ovarian parameters are documented as part of the broader clinical assessment.

CLINICAL Reproductive outcomes

Pregnancy, live birth and follow-up information can be documented where applicable.

These are study endpoints and data points. They are not a calculator of an individual patient’s probability of success.

Autologous preparations

Two preparation approaches. Selected clinically, observed scientifically.

Standard-PRP and IAS are autologous preparation approaches based on material from the patient’s own blood.

IAS includes additional processing of naturally occurring components from the same autologous blood sample.

The research study does not determine which preparation is used. Selection is made within routine clinical care according to the individual medical situation, availability and informed patient preference.

IAS should not be described as purified exosome therapy or presented as clinically superior to Standard-PRP.

Research governance

Conducted at IVF Baden-Baden.

The study is conducted under the direction of Prof. Dr. med. Wolfgang Küpker.

Study centre IVF Baden-Baden · Germany
Principal Investigator Prof. Dr. med. Wolfgang Küpker
Research samples Blood, PRP, IAS and cumulus-cell aliquots where applicable and authorised.
Data Study data are handled in pseudonymised form.
Identification key Remains under the responsibility of IVF Baden-Baden / the Principal Investigator.

Important research information

Research participation should be understood separately from treatment.

Does this page confirm whether I am eligible for ExoRegenOvo?
No. The information above describes general study characteristics. Final eligibility can only be confirmed by the authorised medical and research teams after the full protocol criteria are reviewed.
Does the study decide whether I receive Standard-PRP or IAS?
No. The preparation is selected as part of routine clinical care independently from participation in 02-REGEN-AR.
Does participating guarantee that my ovarian response will improve?
No. Participation does not guarantee improved ovarian reserve, ovarian response, embryo number, pregnancy or live birth.
Does research participation mean that treatment is free?
No. The project documentation distinguishes between no additional cost for the research itself and the costs of routine clinical treatment. Research participation should not be presented as free fertility treatment.
Can I join the study directly through this website?
No direct study inclusion is confirmed through Global Medicare. The appropriate route is an initial clinical evaluation; any possible research invitation is assessed later within the authorised clinical and research pathway.

Your next step

Interested in discussing your ovarian situation?

The Ovarian Program is the patient pathway for initial orientation, specialist evaluation and coordination with IVF Baden-Baden. Research participation, when applicable, is considered separately by the authorised team.

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