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

March 22, 2012 updated by: Zijiang Chen, Shandong University

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

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 Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Enrollment (Anticipated)

2000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shandong
      • Jinan, Shandong, China, 250000
        • Recruiting
        • Shandong University reproductive medicine researche center
        • Contact:
        • Principal Investigator:
          • Zijiang Chen, professor

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 38 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Probability Sample

Study Population

Patients addressed to follicular stimulation for in vitro fertilisation purposes will constitute the study population.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

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).
Drug: hFSH（Fostimon）
After down-regulation (long 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).
Drug: hFSH（Fostimon）
After down-regulation (long 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 (short protocol), all patients will be stimulated with hFSH (human-derived FSH).
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 (short protocol), all patients will be stimulated with hFSH (human-derived FSH).
Drug: hFSH（Fostimon）
After down-regulation (long protocol), all patients will be stimulated with hFSH (human-derived FSH).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shandong University

Collaborators

The Second Hospital of Hebei Medical University
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
The First Affiliated Hospital of Zhengzhou University
IBSA Institut Biochimique SA

Investigators

  • Study Director: Zijiang Chen, Professor, Director of Shandong University reproductive medicine study center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2010

Primary Completion (Anticipated)

April 1, 2013

Study Completion (Anticipated)

April 1, 2013

Study Registration Dates

First Submitted

April 20, 2010

First Submitted That Met QC Criteria

April 20, 2010

First Posted (Estimate)

April 21, 2010

Study Record Updates

Last Update Posted (Estimate)

March 26, 2012

Last Update Submitted That Met QC Criteria

March 22, 2012

Last Verified

April 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • chenzj

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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