Age-related Variability of the Efficacy and Tolerability of Alternative Pituitary Suppression Regimens in ART
NCT ID: NCT01107470
Last Updated: 2012-03-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
2000 participants
OBSERVATIONAL
2010-04-30
2013-04-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Group A1
Age 18-34y (with short protocol)
hFSH（Fostimon）
After down-regulation (short protocol), all patients will be stimulated with hFSH (human-derived FSH).
Group A2
age 35-42y ( with short protocol)
hFSH（Fostimon）
After down-regulation (short protocol), all patients will be stimulated with hFSH (human-derived FSH).
Group B1
age 18-34y ( with long protocol)
hFSH（Fostimon）
After down-regulation (long protocol), all patients will be stimulated with hFSH (human-derived FSH).
Group B2
age 35-42y ( with long protocol)
hFSH（Fostimon）
After down-regulation (long protocol), all patients will be stimulated with hFSH (human-derived FSH).
Interventions
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hFSH（Fostimon）
After down-regulation (short protocol), all patients will be stimulated with hFSH (human-derived FSH).
hFSH（Fostimon）
After down-regulation (short protocol), all patients will be stimulated with hFSH (human-derived FSH).
hFSH（Fostimon）
After down-regulation (long protocol), all patients will be stimulated with hFSH (human-derived FSH).
hFSH（Fostimon）
After down-regulation (long protocol), all patients will be stimulated with hFSH (human-derived FSH).
Eligibility Criteria
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Inclusion Criteria
* 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
* Hypersensitivity to study drugs
* Major illnesses (to be specified)
* PCOS
18 Years
42 Years
FEMALE
No
Sponsors
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The First Affiliated Hospital of Zhengzhou University
OTHER
IBSA Institut Biochimique SA
INDUSTRY
The Second Hospital of Hebei Medical University
OTHER
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
OTHER
Shandong University
OTHER
Responsible Party
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Zijiang Chen
Professor
Principal Investigators
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Zijiang Chen, Professor
Role: STUDY_DIRECTOR
Director of Shandong University reproductive medicine study center
Locations
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Shandong University reproductive medicine researche center
Jinan, Shandong, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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chenzj
Identifier Type: -
Identifier Source: org_study_id
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