Other Complications Associated With Artificial FertilizationNCT01291212
Efficacy of Luteinizing Hormone (LH) Activity in Low Responder Patients With Transdermal Testosterone
A study testing Testosterone and FSHr-LHr and testosterone and FSHr alone in people with Other Complications Associated With Artificial Fertilization, run by Hospital Clinic of Barcelona at 1 site in Spain.
Trial summary
The investigators have previously demonstrated the utility of transdermal testosterone in in vitro fertilization (IVF) low responder patients. Now, the investigators want to evaluate the efficacy of luteinizing hormone (LH) activity added to recombinant follicular stimulating hormone (FSHr) during ovarian stimulation… Read more about this study
- Who is it for?
- Ages 18 to 41 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Other Complications Associated With Artificial Fertilization
- What is being tested?
- Testosterone and FSHr-LHr and testosterone and FSHr alone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 104 participants
- Where
- 1 siteSpain
- Study dates
- Jan 2011to Sep 2011
- 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 18 to 41 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Low responder patients: patients with previously canceled cycle or recovery of 3 or less oocytes
Who cannot join
- FSH > 12
- Previous ovarian surgery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of LH Activity in Low Responder Patients With Transdermal Testosterone: a Randomised Controlled Study.
The investigators have previously demonstrated the utility of transdermal testosterone in in vitro fertilization (IVF) low responder patients. Now, the investigators want to evaluate the efficacy of luteinizing hormone (LH) activity added to recombinant follicular stimulating hormone (FSHr) during ovarian stimulation in these patients.
Read the detailed description
Studies in macaques have indicated that androgens have some synergistic effects with follicular stimulating hormone (FSH) on folliculogenesis. Our previous clinical studies demonstrated the usefulness of pretreatment with transdermal testosterone in low-responder IVF patients.
There is controversy on the usefulness of recombinant luteinizing hormone (LHr) added to FSHr in ovarian stimulation of low responder patients. Thus, our present study has been designed to compare ovarian stimulation with FSHr alone versus LHr added to FSHr when transdermal testosterone pretreatment is used.
- Being tested
- Testosterone and FSHr-LHr, testosterone and FSHr alone
- Keywords
- In Vitro Fertilization, Testosterone, Ovarian Stimulation, Luteinizing Hormone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Testosterone and FSHr-LHrDrug
75U of LHr added to FSHr ovarian stimulation in IVF, when testosterone was used to improve the ovarian response
testosterone and FSHr aloneDrug
FSHr alone used in ovarian stimulation in IVF, when testosterone was used to improve the ovarian response
| Study group | Role | What they receive |
|---|---|---|
| Testosterone and FSHr | Active comparator | Not described Receives: Drug: testosterone and FSHr alone |
| testosterone and FSHr-LHr | Active comparator | Not described Receives: Drug: Testosterone and FSHr-LHr |
What is being measured
The primary outcome is the main question the study is designed to answer.
ovarian response
number of oocytes obtained per ovarian stimulation cycle
Measured: within 2 weeks after begining ovarian stimulation
Secondary outcomes (3)
clinical pregnancy rate
The number of clinical pregnancies expressed per embryo transfer cycles. Clinical pregnancy: a pregnancy diagnosed by ultrasonographic visualization of one or more gestational sacs or definitive clinical signs of pregnancy. It includes ectopic pregnancy. Multiple gestational sacs are counted as one clinical pregnancy.
Measured: within 5 weeks (plus or minus 1 week) after embryo transfer
Implantation rate
The number of gestational sacs (observed by ultrasound examination) divided by the number of embryos transferred.
Measured: within 5 weeks (plus/minus 1 week) after embryo transfer
Live birth rate
The number of deliveries that resulted in at least one live born baby expressed per 100 embryo transfer cycles.
Measured: within 9 months (plus/minus 1 month) after embryo transfer
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2011 (estimated)
- Study startJan 2011
- Primary completionJun 2011 (estimated)
- Study completionSep 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Other Complications Associated With Artificial FertilizationStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Clinic of Barcelona
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01291212
- Sponsor's protocol ID
- FIV-01
- Status last verified
- Jan 2011
- First submitted
- 7 Feb 2011
- Last updated
- 8 Feb 2011
- Results posted
- No
- Data monitoring committee
- 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 16517559Fabregues F, Penarrubia J, Creus M, Manau D, Casals G, Carmona F, Balasch J. Transdermal testosterone may improve ovarian response to gonadotrophins in low-responder IVF patients: a randomized, clinical trial. Hum Reprod. 2009 Feb;24(2):349-59. doi: 10.1093/humrep/den428. Epub 2008 Dec 3.
PubMed 19054777
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of LH Activity in Low Responder Patients With Transdermal Testosterone: a Randomised Controlled Study.
- ClinicalTrials.gov ID
- NCT01291212
- Acronym / sponsor ID
- FIV-01
- Keywords
- In Vitro Fertilization, Testosterone, Ovarian Stimulation, Luteinizing Hormone
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 104 participants (actual)
- Lead sponsor
- Hospital Clinic of BarcelonaUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- Jun 2011 (estimated)
- Study completion
- Sep 2011 (estimated)
- First posted
- 8 Feb 2011 (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.
The investigators have previously demonstrated the utility of transdermal testosterone in in vitro fertilization (IVF) low responder patients. Now, the investigators want to evaluate the efficacy of luteinizing hormone (LH) activity added to recombinant follicular stimulating hormone (FSHr) during ovarian stimulation in these patients.
Detailed description
Studies in macaques have indicated that androgens have some synergistic effects with follicular stimulating hormone (FSH) on folliculogenesis. Our previous clinical studies demonstrated the usefulness of pretreatment with transdermal testosterone in low-responder IVF patients.
There is controversy on the usefulness of recombinant luteinizing hormone (LHr) added to FSHr in ovarian stimulation of low responder patients. Thus, our present study has been designed to compare ovarian stimulation with FSHr alone versus LHr added to FSHr when transdermal testosterone pretreatment is used.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Testosterone and FSHr | Active comparator | Drug: testosterone and FSHr alone |
| testosterone and FSHr-LHr | Active comparator | Drug: Testosterone and FSHr-LHr |
Who may qualify
- Ages
- 18 to 41 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Low responder patients: patients with previously canceled cycle or recovery of 3 or less oocytes
Key exclusion criteria (2 listed)
- FSH > 12
- Previous ovarian surgery
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 and FSHr-LHr75U of LHr added to FSHr ovarian stimulation in IVF, when testosterone was used to improve the ovarian response | Drug | testosterone and FSHr-LHr |
| testosterone and FSHr aloneFSHr alone used in ovarian stimulation in IVF, when testosterone was used to improve the ovarian response | Drug | Testosterone and FSHr |
Primary outcome
ovarian response
Time frame: within 2 weeks after begining ovarian stimulation
number of oocytes obtained per ovarian stimulation cycle
3 secondary outcomes
clinical pregnancy rate
Time frame: within 5 weeks (plus or minus 1 week) after embryo transfer
Implantation rate
Time frame: within 5 weeks (plus/minus 1 week) after embryo transfer
Live birth rate
Time frame: within 9 months (plus/minus 1 month) after embryo transfer
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2011.
- 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.
- Results publication: PubMed 19054777Fabregues F, Penarrubia J, Creus M, Manau D, Casals G, Carmona F, Balasch J. Transdermal testosterone may improve ovarian response to gonadotrophins in low-responder IVF patients: a randomized, clinical trial. Hum Reprod. 2009 Feb;24(2):349-59. doi: 10.1093/humrep/den428. Epub 2008 Dec 3.
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 study testing Testosterone and FSHr-LHr and testosterone and FSHr alone in people with Other Complications Associated With Artificial Fertilization, 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: status not confirmed, as of the sponsor's last update on 8 Feb 2011. 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.
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?
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?
ovarian response (time frame: within 2 weeks after begining ovarian stimulation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01291212, which also lists 2 linked publications.
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 8 Feb 2011.