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

Study Overview
=================
Brief 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).

Detailed 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: 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

Official Title
-----------------
Age Versus Ovarian Reserve Markers Based Therapy in IN Vitro Fertilization

Conditions
-----------------
In Vitro Fertilization, Ovarian Stimulation

Intervention / Treatment
-----------------
* Drug: rFSH
* Drug: buserelin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: first or second IVF/ICSI attempt (the second one after 6 months from the first one);regular menstrual cycles (25-33 days);female age ≤ 40; day 3 FSH ≤ 15IU/L;treatment with a long GnRH agonist protocol (buserelin)+rFSH;BMI: >18 and ≤ 25 kg/m2;presence of both ovaries. Exclusion Criteria: irregular cycles, anovulatory infertility, endometriosis III-IV stage AFS, use of adjunctive therapies for stimulation, evidence of PCO status, previous ovarian surgery, presence of ovarian cysts, history of PID, use of hormonal contraception in the previous 3 months, any known metabolic or endocrinological disease, AMH levels < 1 and > 4.0 ng/ml

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group A: age<br>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. | Drug: rFSH<br> <br> Drug: buserelin<br> <br> |
| Experimental: Group B: nomogram<br>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. | Drug: rFSH<br> <br> Drug: buserelin<br> <br> |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The percentage of women with an appropriate number (N=8-14) of retrieved oocytes in IVF/ICSI cycles |  | 24 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Starting dose, rFSH, controlled, ovarian, stimulation, IVF/ICSI, cycles