Long-term Endogenous Androgen Priming in Bologna Criteria Poor Responder Patients - A Pilot Study (NCT03447184) | Clinical Trial Compass
CompletedNot Applicable
Long-term Endogenous Androgen Priming in Bologna Criteria Poor Responder Patients - A Pilot Study
Vietnam30 participantsStarted 2018-03-26
Plain-language summary
Until now no scientific clinical evidence exists regarding the possible impact of long term endogenous androgen priming in IVF patients aligned with the Bologna Criteria, in specific the impact of priming on serum parameters correlated with the ovarian reserve, antral follicle count, and the number of retrievable follicles. Thus, this pilot-study will explore a new suggested protocol for the Bologna criteria patient developed from basic physiology, and will if successful result in a subsequent randomized controlled trial in the same subset of patients, enabling a possible paradigm shift in the treatment of poor ovarian response (POR).
Who can participate
Age range18 Years – 41 Years
SexFEMALE
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Age 18 - 41 years
* BMI \< 30 kg/m2
* Ovarian reserve, according to the ESHRE Bologna Criteria measured within two months prior to stimulation start
Bologna criteria: At least two of the following three features present:
* Advanced maternal age (≥40 years) or any other risk factor for POR
* A previous POR (≤3 oocytes with a conventional stimulation protocol)
* An abnormal ovarian reserve test (i.e. antral follicle count \< 5-7 follicles or AMH\< 0.5 - 1.1 ng/mL)
* Poor responder if - Two previous episodes of POR after maximal stimulation (300 IU)
* Receiving GnRH-antagonist co-treatment during ovarian stimulation
* Agreement to participate in the study, and to disclose any medical events to the investigator. The subject must be willing and able to comply with the protocol requirements for the duration of the study.
* Have given written informed consent with the understanding that the subject may withdraw consent at any time without prejudice to future medical care.
Exclusion Criteria:
* Chronical medical conditions like Diabetes, Crohns disease, Thyroid disease, Hepatitis B and Sexually Transmitted Diseases Simultaneous participation in an interventional clinical trial.
What they're measuring
1
Serum concentrations of AMH
Timeframe: 8 weeks after starting androgen priming