Long-term Endogenous Androgen Priming in Bologna Criteria Poor Responder Patients - A Pilot Study
- Conditions
- Poor Ovarian Response
- Interventions
- Drug: Androgen priming
- Registration Number
- NCT03447184
- Lead Sponsor
- Mỹ Đức Hospital
- 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 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).
- 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, 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 patients ≥ 35 years of age. The use of hCG and aromatase inhibitor will stop on the first day of stimulation.
Monitoring will be performed according to the standard procedure of the clinic. Patients will receive a bolus of 6.500 IU rhCG (Ovitrelle, Merck) for triggering of final oocyte maturation. Oocyte pick-up and embryo transfer will be performed according to the policy of the clinic. Oocyte pick-up (OPU) and embryo transfer will be performed according to standard procedures.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 30
- 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.
- Chronical medical conditions like Diabetes, Crohns disease, Thyroid disease, Hepatitis B and Sexually Transmitted Diseases Simultaneous participation in an interventional clinical trial.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Androgen priming Androgen priming Eight weeks prior to stimulation for IVF - at the onset of menses, patients will start treatment with a low dose of rhCG (Ovitrelle). At the same time daily treatment with the aromatase inhibitor will commence, concomitantly with GnRHa down-regulation with a depot GnRHa (28days). After 8 weeks, a standard rFSH stimulation with either 300 IU rFSH or 300 IU rFSH+rLH will start. The androgen priming (hCG and aromatase inhibitor) will stop on the first day of stimulation.
- Primary Outcome Measures
Name Time Method Serum concentrations of AMH 8 weeks after starting androgen priming Blood sampling
- Secondary Outcome Measures
Name Time Method Number of pre-ovulatory follicles Up to 2 weeks after starting FSH stimulation Follicles \>/= 14 mm on ultrasound
Number of antral follicles Up to 2 weeks after starting FSH stimulation Follicles 2-10 mm on ultrasound
Serum concentrations of hCG Up to 2 weeks after starting FSH stimulation Blood sampling
Serum concentrations of testosterone Up to 2 weeks after starting FSH stimulation Blood sampling
Serum concentrations of progesterone Up to 2 weeks after starting FSH stimulation Blood sampling
Trial Locations
- Locations (1)
Lan N Vuong
🇻🇳Ho Chi Minh City, Vietnam