InfertilityNCT00561769
Luteal Phase Commencing of Growth Hormone
An observational study of Infertility, run by Gulhane School of Medicine at 1 site in Turkey (Türkiye).
Trial summary
Commencing of growth hormone in luteal phase when follicular cohort for the next cycle is being gathered may increase mature oocytes in poor responder Read more about this study
- Who is it for?
- Ages 20 to 40 years, women only
- Conditions the study is for
- Infertility
- What is being tested?
- Norditropin pen
- How many people
- 61 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Jan 2005to Nov 2007
- 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 20 to 40 years
- Women only
- No healthy volunteers
- Adult
Study population: poor response to previous COH in the same center
Who may be able to join
- Poor responder
Who cannot join
- FSH >20 IU
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Growth Hormone co-Treatment Within a GnRH Agonist Long Protocol in Patients With Poor Ovarian Response
Commencing of growth hormone in luteal phase when follicular cohort for the next cycle is being gathered may increase mature oocytes in poor responder
- Conditions
- Infertility
- Being tested
- Norditropin pen
- Keywords
- poor responder, growth hormone, luteal
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Norditropin penDrug
12 IU per day
| Study group | Role | What they receive |
|---|---|---|
| A | poor responder Receives: Drug: Norditropin pen |
What is being measured
The primary outcome is the main question the study is designed to answer.
mature oocyte number
Measured: 2 years
Secondary outcomes (1)
pregnancy rate
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2007 (estimated)
- Study startJan 2005
- Study completionNov 2007
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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gulhane School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Ren-Tıp ART Center, Bursa, Turkey
- Investigators
- Tansu Kucuk, Assoc Prof, Study director, GATA Ankara
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00561769
- Sponsor's protocol ID
- GATA 2005-21
- Status last verified
- Nov 2007
- First submitted
- 19 Nov 2007
- Last updated
- 21 Nov 2007
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Growth Hormone co-Treatment Within a GnRH Agonist Long Protocol in Patients With Poor Ovarian Response
- ClinicalTrials.gov ID
- NCT00561769
- Acronym / sponsor ID
- GATA 2005-21
- Conditions
- Infertility
- Keywords
- poor responder, growth hormone, luteal
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Gulhane School of MedicineUniversity, hospital or other
- Collaborators
- Ren-Tıp ART Center, Bursa, Turkey
- Study start
- Jan 2005
- Study completion
- Nov 2007 (actual)
- First posted
- 21 Nov 2007 (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.
Commencing of growth hormone in luteal phase when follicular cohort for the next cycle is being gathered may increase mature oocytes in poor responder
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| A | – | Drug: Norditropin penpoor responder |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- poor response to previous COH in the same center
Key inclusion criteria (1 listed)
- Poor responder
Key exclusion criteria (1 listed)
- FSH >20 IU
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 |
|---|---|---|
| Norditropin pen12 IU per day | Drug | A |
Primary outcome
mature oocyte number
Time frame: 2 years
1 secondary outcome
pregnancy rate
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2007.
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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.
Tansu Kucuk, Assoc Prof study director
GATA Ankara
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 Gulhane School of Medicine 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: finished, as of the sponsor's last update on 21 Nov 2007. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
mature oocyte number (time frame: 2 years). 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 21 Nov 2007.