Age Versus Ovarian Reserve Markers Based Therapy in IVF (IVF)/Intracytoplasmic Sperm Injection (ICSI) Cycles
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|ClinicalTrials.gov Identifier: NCT01816789|
Recruitment Status : Terminated (Optimal response: 63% nomogram, 42% controls, overcoming the stopping rule for interim analysis)
First Posted : March 22, 2013
Last Update Posted : December 23, 2016
|Condition or disease||Intervention/treatment||Phase|
|In Vitro Fertilization Ovarian Stimulation||Drug: rFSH Drug: buserelin||Phase 4|
Before clinicians can adopt any model into routine clinical practice, the accuracy of the model should be independently evaluated in a population different from the one on which the model was elaborated. External validation of the model is therefore crucial to assess the generalizability to other populations.
In the present RCT the new AMH-based individualized treatment will be compared to the wide accepted age-based strategy.
The percentage of women with an appropriate number (n=8-14) of retrieved oocytes in IVF/ICSI cycle.
- Serum E2 levels on r-hCG day
- Serum P levels on r-hCG day
- Number of growing follicles (≥11mm) on r-hCG day
- Number of large (≥ 17 mm) ovarian follicles on r-hCG day
- Total r-FSH dose employed
- Treatment duration
- Rate of women with dose adjustment
- Number of cancelled cycles because of poor and hyper-response
- Fertilization rate
- Embryos obtained
- Implantation rates
- Biochemical pregnancy rates
- Clinical pregnancy rates
- OHSS rates
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||194 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Age Versus Ovarian Reserve Markers Based Therapy in IN Vitro Fertilization|
|Study Start Date :||March 2013|
|Actual Primary Completion Date :||July 2016|
|Actual Study Completion Date :||July 2016|
Active Comparator: Group A: "age"
Group A: long standard protocol (buserelin 0.1 ml s.c. twice per day from the 21st day of the cycle, until the end of gonadotropin administration) + 150 IU of rFSH (starting dose) if female age was ≤35 years or 225 IU of rFSH if female age was ≥ 36 years.
Experimental: Group B: "nomogram"
Group B: long standard protocol (buserelin 0.1 ml s.c. twice per day from the 21st day of the cycle until the end of gonadotropin administration) + individualized starting dose of rFSH on the basis of the nomogram.
- The percentage of women with an appropriate number (N=8-14) of retrieved oocytes in IVF/ICSI cycles [ Time Frame: 24 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01816789
|ANDROS Day Surgery Clinic|
|Palermo, Sicily, Italy, 90144|