Infertility, FemalePhase 4NCT03078569
Transdermal Testosterone for Poor Responder Patients Undergoing Controlled Ovarian Stimulation Prior to IVF
A Phase 4 study testing Testosterone gel in people with Infertility, Female, run by Wolfson Medical Center at 1 site in Israel.
Trial summary
This study evaluates the efficacy of pre- IVF treatment with transdermal testosterone to enhance ovarian response in poor responders. a randomized controlled trial with two groups, treatment group with transdermal testosterone before IVF treatment and a control group with no treatment. Read more about this study
- Who is it for?
- Ages 30 to 42 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Infertility, Female
- What is being tested?
- Testosterone gel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteIsrael
- Study dates
- Mar 2017to Jul 2018
- Phase
- Phase 4
- 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 30 to 42 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- infertility patients undergoing ART regular menses normal function of thyroid, liver and kidney normal BMI (19.3-28.9) without use of any fertility drugs in the previous two months
Who cannot join
- patients with recurrent implantations failure (3 cycles and more) previous ovarian surgery uncontrolled medical illness severe endometriosis (stage 3-4) contraindication for testosterone use
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Wolfson MC
Holon
Amir Mr shalev, MD, 97235028105, amirshalev75@yahoo.com
About this study
Official title: Transdermal Testosterone for Poor Responders Undergoing IVF
This study evaluates the efficacy of pre- IVF treatment with transdermal testosterone to enhance ovarian response in poor responders.
a randomized controlled trial with two groups, treatment group with transdermal testosterone before IVF treatment and a control group with no treatment.
Read the detailed description
One of the major challenges of Assisted reproduction technology is treating women with low ovarian response,those women achieve very poor pregnancy rate with IVF.
in recent years there is a focus
- Conditions
- Infertility, Female
- Being tested
- Testosterone gel
- Keywords
- Poor responders
- Medical subject headings
- Infertility, Female
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Testosterone gelDrug
Also called testomax
treatment with testosterone gel
| Study group | Role | What they receive |
|---|---|---|
| testosterone gel | Experimental | testosterone gel treatment group Receives: Drug: Testosterone gel |
| Control group | No intervention | without testosterone treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
number of retrieved oocytes
number of oocytes
Measured: 2 year
Secondary outcomes (1)
number of clinical pregnancies
number of pregnancies with fetal cardiac activity
Measured: 2.5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2017
- Study startMar 2017 (estimated)
- Primary completionMar 2018 (estimated)
- Study completionJul 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infertility, FemaleStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wolfson Medical Center
- Sponsor type
- Other government
- Responsible party
- Principal investigator, amir shalev, Wolfson Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03078569
- Sponsor's protocol ID
- wolfson testosterone 1
- Status last verified
- Mar 2017
- First submitted
- 8 Mar 2017
- Last updated
- 13 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transdermal Testosterone for Poor Responders Undergoing IVF
- ClinicalTrials.gov ID
- NCT03078569
- Acronym / sponsor ID
- wolfson testosterone 1
- Conditions
- Infertility, Female
- Keywords
- Poor responders
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Wolfson Medical CenterOther government
- Study start
- Mar 2017 (estimated)
- Primary completion
- Mar 2018 (estimated)
- Study completion
- Jul 2018 (estimated)
- First posted
- 13 Mar 2017 (actual)
- 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.
This study evaluates the efficacy of pre- IVF treatment with transdermal testosterone to enhance ovarian response in poor responders.
a randomized controlled trial with two groups, treatment group with transdermal testosterone before IVF treatment and a control group with no treatment.
Detailed description
One of the major challenges of Assisted reproduction technology is treating women with low ovarian response,those women achieve very poor pregnancy rate with IVF.
in recent years there is a focus
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| testosterone gel | Experimental | Drug: Testosterone geltestosterone gel treatment group |
| Control group | No intervention | –without testosterone treatment |
Who may qualify
- Ages
- 30 to 42 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- infertility patients undergoing ART regular menses normal function of thyroid, liver and kidney normal BMI (19.3-28.9) without use of any fertility drugs in the previous two months
Key exclusion criteria (1 listed)
- patients with recurrent implantations failure (3 cycles and more) previous ovarian surgery uncontrolled medical illness severe endometriosis (stage 3-4) contraindication for testosterone use
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 |
|---|---|---|
| Testosterone gelAlso: testomaxtreatment with testosterone gel | Drug | testosterone gel |
Primary outcome
number of retrieved oocytes
Time frame: 2 year
number of oocytes
1 secondary outcome
number of clinical pregnancies
Time frame: 2.5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2017.
- Individual participant dataSharing planned: No
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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 Phase 4 study testing Testosterone gel in people with Infertility, Female, run by Wolfson Medical Center at 1 site in Israel.
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 13 Mar 2017. 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 Israel. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 amir Mr shalev, MD (97235028105, amirshalev75@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
number of retrieved oocytes (time frame: 2 year). 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 13 Mar 2017.