Long-term Endogenous Androgen Priming in Bologna Criteria Poor Responder Patients - A Pilot Study
Launched by MỸ ĐỨC HOSPITAL · Feb 25, 2018
Trial Information
Current as of May 29, 2025
Completed
Keywords
ClinConnect Summary
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, patients will start treatment with a low dose of rhCG (Ovitrelle). At the same time daily treatment with the aromatase inhibitor daily will commence, concomitantly with GnRHa down-regulation with a depot GnRHa.
After 8 weeks, stimulation will be performed with a fixed dose of 300 IU rFSH (Gonal F, Merck) for the first 5 days in patients ≤ 34 years of age and 300 IU Pergoveris (Merck) in patie...
Gender
FEMALE
Eligibility criteria
- 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.
About Mỹ đức Hospital
Mỹ Đức Hospital is a leading healthcare institution dedicated to advancing medical research and improving patient outcomes through innovative clinical trials. With a strong emphasis on ethical practices and patient safety, the hospital collaborates with reputable research organizations and healthcare professionals to conduct studies across various therapeutic areas. Committed to excellence in clinical research, Mỹ Đức Hospital leverages its state-of-the-art facilities and experienced staff to contribute valuable insights that enhance medical knowledge and treatment options for diverse patient populations.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Ho Chi Minh City, , Vietnam
Patients applied
Trial Officials
Tuong M Ho, MD
Principal Investigator
Mỹ Đức Hospital
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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