Status:
COMPLETED
Long-term Endogenous Androgen Priming in Bologna Criteria Poor Responder Patients - A Pilot Study
Lead Sponsor:
Mỹ Đức Hospital
Conditions:
Poor Ovarian Response
Eligibility:
FEMALE
18-41 years
Brief 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 pri...
Detailed Description
A single center study pilot study in 30 IVF Bologna criteria POR patients. All patients fulfilling the ESHRE Bologna criteria will be eligible for inclusion. Eight weeks prior to stimulation for IVF,...
Eligibility Criteria
Inclusion
- 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
- Chronical medical conditions like Diabetes, Crohns disease, Thyroid disease, Hepatitis B and Sexually Transmitted Diseases Simultaneous participation in an interventional clinical trial.
Key Trial Info
Start Date :
March 26 2018
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
March 1 2019
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT03447184
Start Date
March 26 2018
End Date
March 1 2019
Last Update
July 5 2019
Active Locations (1)
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1
Lan N Vuong
Ho Chi Minh City, Vietnam