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Age Versus Ovarian Reserve Markers Based Therapy in IVF (IVF)/Intracytoplasmic Sperm Injection (ICSI) Cycles

In Vitro Fertilization Clinical Trial

Official title:
Age Versus Ovarian Reserve Markers Based Therapy in IN Vitro Fertilization

Clinical Trial Summary

This randomized controlled trial has been designed for carrying out a comparison of new AMH (Anti-Müllerian Hormone)-based individualized treatment (using a nomogram) with the wide accepted age-based strategy. The main objective of the trial is to assess whether an individualized FSH starting dose can increase the rate of women with an adequate ovarian response in terms of retrieved oocytes (optimal number of retrieved oocytes: 8-14).

Clinical Trial Description

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.

Primary endpoint:

The percentage of women with an appropriate number (n=8-14) of retrieved oocytes in IVF/ICSI cycle.

Secondary endpoints:

1. Serum E2 levels on r-hCG day

2. Serum P levels on r-hCG day

3. Number of growing follicles (≥11mm) on r-hCG day

4. Number of large (≥ 17 mm) ovarian follicles on r-hCG day

5. Total r-FSH dose employed

6. Treatment duration

7. Rate of women with dose adjustment

8. Number of cancelled cycles because of poor and hyper-response

9. Fertilization rate

10. Embryos obtained

11. Implantation rates

12. Biochemical pregnancy rates

13. Clinical pregnancy rates

14. OHSS rates ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01816789
Study type Interventional
Source Andros Day Surgery Clinic
Contact
Status Terminated
Phase Phase 4
Start date March 2013
Completion date July 2016
View Details
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