InfertilityNCT00677573
Efficacy of Urinary Follicle-Stimulating Hormone (FSH) Among Poor Responders
A study testing Fostimon in people with Infertility, run by German Hospital, Istanbul at 1 site in Turkey (Türkiye).
Trial summary
We proposed to compare outcomes in women with DOR undergoing ART with rec-FSH + u-HMH with those with u-FSH only in GnRH antagonist protocols. Read more about this study
- Who is it for?
- Ages 20 to 44 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Infertility
- What is being tested?
- Fostimon
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- Not given
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- May 2008to Nov 2008
- Phase
- Interventional
- 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 20 to 44 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- At least one trial with adequate ovarian stimulation resulted by 4 or less oocytes retrieval.
Who cannot join
- High responder patients
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Alman Hastanesi
Istanbul, Istanbul
Haluk Toygarlı, M.D., 90-21-2293-2150
ulun ulug, M.D.
About this study
Official title: Comparison of Urinary Purified Follicle-Stimulating Hormone (FSH) and Rec-FSH Among Poor Responders Undergoing Ovarian Stimulation With GnRH Antagonist
We proposed to compare outcomes in women with DOR undergoing ART with rec-FSH + u-HMH with those with u-FSH only in GnRH antagonist protocols.
- Conditions
- Infertility
- Being tested
- Fostimon
- Keywords
- ART, poor responder, GnRH antagonist, Gonadotropins
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FostimonDrug
450 IU for 4 days then adjusted
| Study group | Role | What they receive |
|---|---|---|
| UrFSH | Active comparator | Not described Receives: Drug: Fostimon |
What is being measured
The primary outcome is the main question the study is designed to answer.
pregnancy rate per embryo transfer
Measured: 6 months
Secondary outcomes (1)
number of oocytes retrieved
Measured: per patient
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2008 (estimated)
- Study startMay 2008
- Primary completionOct 2008 (estimated)
- Study completionNov 2008 (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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Sponsor and investigators
- Lead sponsor
- German Hospital, Istanbul
- Sponsor type
- University, hospital or other
- Collaborators
- Bahceci Women Health Care Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00677573
- Sponsor's protocol ID
- ughno1
- Status last verified
- May 2008
- First submitted
- 9 May 2008
- Last updated
- 14 May 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Urinary Purified Follicle-Stimulating Hormone (FSH) and Rec-FSH Among Poor Responders Undergoing Ovarian Stimulation With GnRH Antagonist
- ClinicalTrials.gov ID
- NCT00677573
- Acronym / sponsor ID
- ughno1
- Conditions
- Infertility
- Keywords
- ART, poor responder, GnRH antagonist, Gonadotropins
- Study type
- Interventional
- Recruitment status
- Unknown status
- Lead sponsor
- German Hospital, IstanbulUniversity, hospital or other
- Collaborators
- Bahceci Women Health Care Center
- Study start
- May 2008
- Primary completion
- Oct 2008 (estimated)
- Study completion
- Nov 2008 (estimated)
- First posted
- 14 May 2008 (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.
We proposed to compare outcomes in women with DOR undergoing ART with rec-FSH + u-HMH with those with u-FSH only in GnRH antagonist protocols.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| UrFSH | Active comparator | Drug: Fostimon |
Who may qualify
- Ages
- 20 to 44 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- At least one trial with adequate ovarian stimulation resulted by 4 or less oocytes retrieval.
Key exclusion criteria (1 listed)
- High responder patients
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 |
|---|---|---|
| Fostimon450 IU for 4 days then adjusted | Drug | UrFSH |
Primary outcome
pregnancy rate per embryo transfer
Time frame: 6 months
1 secondary outcome
number of oocytes retrieved
Time frame: per patient
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2008.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fostimon in people with Infertility, run by German Hospital, Istanbul at 1 site in Turkey (Türkiye).
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 1 inclusion and 1 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 14 May 2008. 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 Turkey (Türkiye). 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 Ulun Ulug, M.D. (90-21-2293-2150 ext. 14111, ulunulug@superonline.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pregnancy rate per embryo transfer (time frame: 6 months). It is what the study was designed to measure, not a finding.
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 14 May 2008.