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

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ClinicalTrials.gov Identifier: NCT01107470
Recruitment Status : Unknown
Verified April 2010 by Zijiang Chen, Shandong University.
Recruitment status was:  Recruiting
First Posted : April 21, 2010
Last Update Posted : March 26, 2012
Sponsor:
Collaborators:
The First Affiliated Hospital of Zhengzhou University
IBSA Institut Biochimique SA
The Second Hospital of Hebei Medical University
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Information provided by (Responsible Party):
Zijiang Chen, Shandong University

Brief Summary:
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

Condition or disease Intervention/treatment
Infertility Drug: hFSH(Fostimon)

Detailed Description:

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.


Study Type : Observational
Estimated Enrollment : 2000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: 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
Study Start Date : April 2010
Estimated Primary Completion Date : April 2013
Estimated Study Completion Date : April 2013

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Group A1
Age 18-34y (with short protocol)
Drug: 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)
Drug: 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)
Drug: 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)
Drug: hFSH(Fostimon)
After down-regulation (long protocol), all patients will be stimulated with hFSH (human-derived FSH).





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Ages Eligible for Study:   18 Years to 42 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients addressed to follicular stimulation for in vitro fertilisation purposes will constitute the study population.
Criteria

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

Information from the National Library of Medicine

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): NCT01107470


Contacts
Contact: Zijiang Chen, professor +86-531-85187856 zjchen59@yahoo.com

Locations
China, Shandong
Shandong University reproductive medicine researche center Recruiting
Jinan, Shandong, China, 250000
Contact: Zijiang Chen, professor    +86-531-85187856    zjchen59@yahoo.com   
Principal Investigator: Zijiang Chen, professor         
Sponsors and Collaborators
Shandong University
The First Affiliated Hospital of Zhengzhou University
IBSA Institut Biochimique SA
The Second Hospital of Hebei Medical University
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Investigators
Study Director: Zijiang Chen, Professor Director of Shandong University reproductive medicine study center

Responsible Party: Zijiang Chen, Professor, Shandong University
ClinicalTrials.gov Identifier: NCT01107470     History of Changes
Other Study ID Numbers: chenzj
First Posted: April 21, 2010    Key Record Dates
Last Update Posted: March 26, 2012
Last Verified: April 2010

Keywords provided by Zijiang Chen, Shandong University:
Infertility IVF ART

Additional relevant MeSH terms:
Infertility
Genital Diseases, Male
Genital Diseases, Female