Ovarian ResponsePhase 3NCT00693108
Androgens for Poor Responders in In Vitro Fertilization
A Phase 3 study testing Transdermal testosterone in people with Ovarian Response, run by Hospital Clinic of Barcelona at 1 site in Spain.
Trial summary
it has been shown that androgens in non human primates may favour follicular growth in the ovaries when animals are treated with gonadotropins which are the hormones used in patients receiving treatment with in vitro fertilization. Read more about this study
- Who is it for?
- Ages 19 to 39 years, women only
- Conditions the study is for
- Ovarian Response
- What is being tested?
- Transdermal testosterone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- Not given
- Where
- 1 siteSpain
- Study dates
- Sep 2006to not given
- Phase
- Phase 3
- 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 19 to 39 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Patients receiving the second IVF treatment attempt having the first treatment cycle cancelled because of poor ovarian response to gonadotropins
Who cannot join
- Previous ovarian surgery
- Clinical or laboratory profile suggesting premature ovarian failure
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Transdermal Testosterone to Improve Ovarian Response to Gonadotropins in Poor Responder IVF Patients With Normal Basal Concentrations of FSH
it has been shown that androgens in non human primates may favour follicular growth in the ovaries when animals are treated with gonadotropins which are the hormones used in patients receiving treatment with in vitro fertilization. Therefore, this study investigates the potential usefulness of testosterone treatment preceding gonadotropin administration in in vitro fertilization patients having a previous poor response to gonadotropins alone.
- Conditions
- Ovarian Response
- Being tested
- Transdermal testosterone
- Keywords
- Poor, Response, Ovarian, Stimulation, IVF, Patients
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transdermal testosteroneDrug
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Transdermal testosterone treatment during the five days preceding gonadotropin therapy in IVF cycles Receives: Drug: Transdermal testosterone |
| 2 | No intervention | Not described |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2008 (estimated)
- Study startSep 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Ovarian ResponseStudies of the same condition, open and under way.
- More trials run by Hospital Clinic of BarcelonaThe sponsor's other registered studies.
- 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 3
Sponsor and investigators
- Lead sponsor
- Hospital Clinic of Barcelona
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00693108
- Sponsor's protocol ID
- IVFANDROGENS
- Status last verified
- Jun 2008
- First submitted
- 4 Jun 2008
- Last updated
- 6 Jun 2008
- Results posted
- No
Publications
Balasch J, Fabregues F, Penarrubia J, Carmona F, Casamitjana R, Creus M, Manau D, Casals G, Vanrell JA. Pretreatment with transdermal testosterone may improve ovarian response to gonadotrophins in poor-responder IVF patients with normal basal concentrations of FSH. Hum Reprod. 2006 Jul;21(7):1884-93. doi: 10.1093/humrep/del052. Epub 2006 Mar 3.
PubMed 16517559
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transdermal Testosterone to Improve Ovarian Response to Gonadotropins in Poor Responder IVF Patients With Normal Basal Concentrations of FSH
- ClinicalTrials.gov ID
- NCT00693108
- Acronym / sponsor ID
- IVFANDROGENS
- Conditions
- Ovarian Response
- Keywords
- Poor, Response, Ovarian, Stimulation, IVF, Patients
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Hospital Clinic of BarcelonaUniversity, hospital or other
- Study start
- Sep 2006
- First posted
- 6 Jun 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.
it has been shown that androgens in non human primates may favour follicular growth in the ovaries when animals are treated with gonadotropins which are the hormones used in patients receiving treatment with in vitro fertilization. Therefore, this study investigates the potential usefulness of testosterone treatment preceding gonadotropin administration in in vitro fertilization patients having a previous poor response to gonadotropins alone.
Study design
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Transdermal testosteroneTransdermal testosterone treatment during the five days preceding gonadotropin therapy in IVF cycles |
| 2 | No intervention | – |
Who may qualify
- Ages
- 19 to 39 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Patients receiving the second IVF treatment attempt having the first treatment cycle cancelled because of poor ovarian response to gonadotropins
Key exclusion criteria (2 listed)
- Previous ovarian surgery
- Clinical or laboratory profile suggesting premature ovarian failure
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 |
|---|---|---|
| Transdermal testosterone | Drug | 1 |
Primary outcome
Not reported in the source record.
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 6 Jun 2008.
- Background: PubMed 16517559Balasch J, Fabregues F, Penarrubia J, Carmona F, Casamitjana R, Creus M, Manau D, Casals G, Vanrell JA. Pretreatment with transdermal testosterone may improve ovarian response to gonadotrophins in poor-responder IVF patients with normal basal concentrations of FSH. Hum Reprod. 2006 Jul;21(7):1884-93. doi: 10.1093/humrep/del052. Epub 2006 Mar 3.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Transdermal testosterone in people with Ovarian Response, run by Hospital Clinic of Barcelona at 1 site in Spain.
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 2 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 6 Jun 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 Spain. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00693108, which also lists 1 linked publication.
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 6 Jun 2008.