Age-related Variability of the Efficacy and Tolerability of Alternative Pituitary Suppression Regimens in ART

Study Overview
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Brief Summary
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Age-related variability of the efficacy and tolerability of alternative pituitary suppression regimens in follicular stimulation for assisted reproduction purposes. A randomised, prospective, multi-centre clinical trial

Detailed Description
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Pituitary suppression is strongly advised to be included within the follicular stimulation protocols to avoid the occurrence of a premature LH surge, which leads to cycle cancellation. However, whatever the drug and the schedule selected to achieve it, it is clear that pituitary suppression constitute a major perturbation of the endocrine milieu and that it has an impact on the outcome of the stimulation. Indeed, the data in the literature support the idea that pituitary down-regulation by GnRH agonists according to the so-called long protocol, resulting in a deeper suppression, result in better clinical outcomes as compared to the short protocol, at least in women of younger reproductive age. Conversely, it has been proposed that a less profound suppression (e.g. short protocol), that allows better background regulation from the pituitary, should be preferred in women of advanced reproductive age. However, the majority of the data currently supporting the decision makers in selecting their pituitary suppression strategies is based on studies focussed on standard, good prognosis patients whereas just a few studies have specifically addressed the special issue of the advanced reproductive age. Inasmuch, very few data are available in pure (non resistant) advanced age patients and, however, no studies have compared in the same setting younger vs aged subjects with an adequate sample size. Another intriguing aspect of the question is that the chronological age does not necessarily overlap with the reproductive age which, besides complicating the decisional process in the clinical practise, may also play as a confounding factor in the evaluation of the results from clinical trials. Several studies have validated the role of the so-called follicle antral count (AFC) and the anti-Mullerian hormone (AMH) circulating levels as having a predictive role in the evaluation of the actual reproductive age. In particular the latter, the AMH, appears to be easier to standardise and to be used as the best reference in multicentre clinical studies focussed on the reproductive age. In summary, there is a clear lack of information on the performance of the different GnRH-agonist schedules in alternative chronological and reproductive age groups and the data from a large size prospective trial may generate valuable indications for the daily clinical practise.

Official Title
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Age-related Variability of the Efficacy and Tolerability of Alternative Pituitary Suppression Regimens in Follicular Stimulation for Assisted Reproduction Purposes. A Randomised, Prospective, Multi-centre Clinical Trial

Conditions
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Infertility

Intervention / Treatment
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* Drug: hFSH（Fostimon）
* Drug: hFSH（Fostimon）
* Drug: hFSH（Fostimon）
* Drug: hFSH（Fostimon）


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18 to 42 First IVF attempt BMI 18 to 25 Basal FSH less than 12 for subjects below the age of 35 or less than 15 for subjects aged more than 35 Informed consent Exclusion Criteria: Genital malformation Hypersensitivity to study drugs Major illnesses (to be specified) PCOS

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 42 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Group A1<br>Age 18-34y (with short protocol) | Drug: hFSH（Fostimon）<br>* After down-regulation (short protocol), all patients will be stimulated with hFSH (human-derived FSH).<br>|
| Group A2<br>age 35-42y ( with short protocol) | Drug: hFSH（Fostimon）<br>* After down-regulation (short protocol), all patients will be stimulated with hFSH (human-derived FSH).<br>|
| Group B1<br>age 18-34y ( with long protocol) | Drug: hFSH（Fostimon）<br>* After down-regulation (long protocol), all patients will be stimulated with hFSH (human-derived FSH).<br>|
| Group B2<br>age 35-42y ( with long protocol) | Drug: hFSH（Fostimon）<br>* After down-regulation (long protocol), all patients will be stimulated with hFSH (human-derived FSH).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Infertility IVF ART