InfertilityNCT01107470
Age-related Variability of the Efficacy and Tolerability of Alternative Pituitary Suppression Regimens in ART
An observational study of Infertility, run by Shandong University at 1 site in China.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 42 years, women only
- Conditions the study is for
- Infertility
- What is being tested?
- hFSH（Fostimon）
- How many people
- 2,000 participants
- Where
- 1 siteChina
- Study dates
- Apr 2010to Apr 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 42 years
- Women only
- No healthy volunteers
- Adult
Study population: Patients addressed to follicular stimulation for in vitro fertilisation purposes will constitute the study population.
Who may be able to join
- 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
Who cannot join
- Genital malformation
- Hypersensitivity to study drugs
- Major illnesses (to be specified)
- PCOS
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Shandong University reproductive medicine researche center
Jinan, Shandong, 250000
Zijiang Chen, professor, +86-531-85187856, zjchen59@yahoo.com
Zijiang Chen, professor
About this study
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
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
Read the 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.
- Conditions
- Infertility
- Being tested
- hFSH（Fostimon）
- Keywords
- Infertility IVF ART
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hFSH（Fostimon）Drug
After down-regulation (short protocol), all patients will be stimulated with hFSH (human-derived FSH).
hFSH（Fostimon）Drug
After down-regulation (short protocol), all patients will be stimulated with hFSH (human-derived FSH).
hFSH（Fostimon）Drug
After down-regulation (long protocol), all patients will be stimulated with hFSH (human-derived FSH).
hFSH（Fostimon）Drug
After down-regulation (long protocol), all patients will be stimulated with hFSH (human-derived FSH).
| Study group | Role | What they receive |
|---|---|---|
| Group A1 | Age 18-34y (with short protocol) Receives: Drug: hFSH（Fostimon） | |
| Group A2 | age 35-42y ( with short protocol) Receives: Drug: hFSH（Fostimon） | |
| Group B1 | age 18-34y ( with long protocol) Receives: Drug: hFSH（Fostimon） | |
| Group B2 | age 35-42y ( with long protocol) Receives: Drug: hFSH（Fostimon） |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2010 (estimated)
- Study startApr 2010
- Primary completionApr 2013 (estimated)
- Study completionApr 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfertilityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shandong University
- Sponsor type
- University, hospital or other
- 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
- Responsible party
- Principal investigator, Zijiang Chen, Shandong University
- Investigators
- Zijiang Chen, Professor, Study director, Director of Shandong University reproductive medicine study center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01107470
- Sponsor's protocol ID
- chenzj
- Status last verified
- Apr 2010
- First submitted
- 20 Apr 2010
- Last updated
- 26 Mar 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01107470
- Acronym / sponsor ID
- chenzj
- Conditions
- Infertility
- Keywords
- Infertility IVF ART
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Shandong UniversityUniversity, hospital or other
- 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
- Study start
- Apr 2010
- Primary completion
- Apr 2013 (estimated)
- Study completion
- Apr 2013 (estimated)
- First posted
- 21 Apr 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group A1 | – | Drug: hFSH（Fostimon）Age 18-34y (with short protocol) |
| Group A2 | – | Drug: hFSH（Fostimon）age 35-42y ( with short protocol) |
| Group B1 | – | Drug: hFSH（Fostimon）age 18-34y ( with long protocol) |
| Group B2 | – | Drug: hFSH（Fostimon）age 35-42y ( with long protocol) |
Who may qualify
- Ages
- 18 to 42 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Patients addressed to follicular stimulation for in vitro fertilisation purposes will constitute the study population.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- Genital malformation
- Hypersensitivity to study drugs
- Major illnesses (to be specified)
- PCOS
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| hFSH（Fostimon）After down-regulation (short protocol), all patients will be stimulated with hFSH (human-derived FSH). | Drug | Group A1 |
| hFSH（Fostimon）After down-regulation (short protocol), all patients will be stimulated with hFSH (human-derived FSH). | Drug | Group A2 |
| hFSH（Fostimon）After down-regulation (long protocol), all patients will be stimulated with hFSH (human-derived FSH). | Drug | Group B1 |
| hFSH（Fostimon）After down-regulation (long protocol), all patients will be stimulated with hFSH (human-derived FSH). | Drug | Group B2 |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zijiang Chen, Professor study director
Director of Shandong University reproductive medicine study center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Infertility, run by Shandong University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Mar 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zijiang Chen, professor (+86-531-85187856, zjchen59@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Mar 2012.