InfertilityNCT02549690
Testosterone Gel in Poor Responders Undergoing IVF
A study testing Testosterone gel and DHEA in people with Infertility, run by Vietnam National University at 1 site in Vietnam.
Trial summary
The main purpose of this study is to compare the number of oocytes retrieved after using transdermal testosterone gel 10 mg per day or Dehydroepiandrosterone (DHEA) 75mg per day for 6-8 weeks as pre-treatment for poor ovarian responders undergoing in-vitro fertilization (IVF). Read more about this study
- Who is it for?
- Ages 18 to 42 years, women only
- Conditions the study is for
- Infertility
- What is being tested?
- Testosterone gel and DHEA
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteVietnam
- Study dates
- Sep 2015to Aug 2016
- 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 42 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- To be eligible for enrolment into this trial, each female subject must fulfill all of the following criteria at the start of enrolment, unless specified otherwise:
- Had one or two previous failure IVF cycle, using GnRH antagonist protocol (≥ 300 IU FSH/hMG per day) and the number of retrieved oocytes are ≤ 3;
- Antral follicle counts (AFC) < 6 or Anti-Mullerian Hormone (AMH) < 1.26 ng/ml
Who cannot join
- To be eligible for enrolment in this study each subject must not meet any of the following criteria:
- Oocyte donation cycle
- Patients have thyroid disease
- Patients have liver or kidney dysfunction
- Patients have abnormal puberty or genital development.
- Patients have previous surgery on ovaries
Trial locations and contacts
1 site in 1 country.
Vietnam1 site
My Duc Hospital
Ho Chi Minh City, Ward 13. Tan Binh District, 70000
About this study
Official title: Effectiveness of Testosterone Gel Pretreatment in Poor Responders Undergoing IVF Treatment: a Randomized Controlled Trial
The main purpose of this study is to compare the number of oocytes retrieved after using transdermal testosterone gel 10 mg per day or Dehydroepiandrosterone (DHEA) 75mg per day for 6-8 weeks as pre-treatment for poor ovarian responders undergoing in-vitro fertilization (IVF).
Read the detailed description
A randomized controlled multiple centers study. The study is designed as a superiority trial. The sample size for this trial of 120 subjects in both groups, based upon the primary endpoint of the number of oocytes retrieved.
IVF patients who have failed to conceive and had poor ovarian response (oocytes retrieved ≤ 3) in the last stimulated cycle though using the maximal dose, which is ≥ 300 IU Follicle-stimulating hormone (FSH) or human menopausal gonadotropin (hMG).
Patients will be randomized to use DHEA or testosterone gel as pretreatment. Randomization will be performed using sealed envelopes developed via a computer generated list with blocks of four. Doctors will be blinded to the randomization, but not patients and nurses.
- Study group 1 use 10 mg transdermal testosterone gel per day.
- Study group 2 use 75mg DHEA per day.
Serum testosterone are measured before treatment. Duration of androgen supplement is 6-8 weeks. After completing the pretreatment, patients are asked to come back when they have menses to begin IVF treatment. Serum testosterone is measured again after the pretreatment in both groups. Patients will be interviewed for side effects and compliance of treatment.
After treatment, patients in both group undergo IVF treatment. IVF treatment will then be performed for all patients, according to the current hospital treatment protocols.
Patients will be followed up until 7th week of gestation, if they have positive pregnancy test after embryo transfer.
Data Analysis and Statistics:
The investigators use Statistical Package for the Social Sciences (SPSS) software 20th version to analyze data. The primary end-point mean of number of retrieved oocytes will be compared between two groups using the Student's t test. The secondary end-points will also be compared between the 2 groups using either the Student's t test or chi-square test.
- Conditions
- Infertility
- Being tested
- Testosterone gel, DHEA
- Keywords
- IVF, Testosterone gel, DHEA, poor responder.
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Testosterone gelDrug
Also called Androgel
Apply 10mg testosterone gel to the abdomen and rub on with one finger, once a day, in the morning, then allow sites to dry and cover with clothing. Continue the treatment for 6-8 weeks until next IVF treatment.
DHEADrug
Also called DHEA tablet
Take DHEA 25mg tablet orally, three times per day. Continue the treatment for 6-8 weeks, until next IVF treatment.
| Study group | Role | What they receive |
|---|---|---|
| Testosterone gel | Active comparator | Testosterone gel 10mg, used transdermally, once a day. Treatment duration: 6-8 weeks Receives: Drug: Testosterone gel |
| DHEA | Active comparator | DHEA 25mg tablet, orally, three times per day. Treatment duration: 6-8 weeks Receives: Drug: DHEA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of oocytes
Number of oocytes retrieved Number of oocytes retrieved
Measured: 30 minutes after oocyte retrieval completed
Secondary outcomes (1)
Clinical pregnancy
Clinical pregnancy is defined by the image gestational sac under ultrasonography
Measured: 7 weeks 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 posted15 Sep 2015 (estimated)
- Study startSep 2015
- Primary completionMay 2016 (estimated)
- Study completionAug 2016 (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)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vietnam National University
- Sponsor type
- University, hospital or other
- Collaborators
- Mỹ Đức Hospital
- Responsible party
- Principal investigator, Manh Tuong Ho, Vietnam National University
- Investigators
- Linh P Tran, MD, Study director, Research Center for Genetics and Reproductive Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02549690
- Sponsor's protocol ID
- NCKH/CGRH_ 06_2015
- Status last verified
- Apr 2017
- First submitted
- 13 Sep 2015
- Last updated
- 18 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Testosterone Gel Pretreatment in Poor Responders Undergoing IVF Treatment: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02549690
- Acronym / sponsor ID
- NCKH/CGRH_ 06_2015
- Conditions
- Infertility
- Keywords
- IVF, Testosterone gel, DHEA, poor responder.
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Vietnam National UniversityUniversity, hospital or other
- Collaborators
- Mỹ Đức Hospital
- Study start
- Sep 2015
- Primary completion
- May 2016 (estimated)
- Study completion
- Aug 2016 (estimated)
- First posted
- 15 Sep 2015 (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 main purpose of this study is to compare the number of oocytes retrieved after using transdermal testosterone gel 10 mg per day or Dehydroepiandrosterone (DHEA) 75mg per day for 6-8 weeks as pre-treatment for poor ovarian responders undergoing in-vitro fertilization (IVF).
Detailed description
A randomized controlled multiple centers study. The study is designed as a superiority trial. The sample size for this trial of 120 subjects in both groups, based upon the primary endpoint of the number of oocytes retrieved.
IVF patients who have failed to conceive and had poor ovarian response (oocytes retrieved ≤ 3) in the last stimulated cycle though using the maximal dose, which is ≥ 300 IU Follicle-stimulating hormone (FSH) or human menopausal gonadotropin (hMG).
Patients will be randomized to use DHEA or testosterone gel as pretreatment. Randomization will be performed using sealed envelopes developed via a computer generated list with blocks of four. Doctors will be blinded to the randomization, but not patients and nurses.
- Study group 1 use 10 mg transdermal testosterone gel per day.
- Study group 2 use 75mg DHEA per day.
Serum testosterone are measured before treatment. Duration of androgen supplement is 6-8 weeks. After completing the pretreatment, patients are asked to come back when they have menses to begin IVF treatment. Serum testosterone is measured again after the pretreatment in both groups. Patients will be interviewed for side effects and compliance of treatment.
After treatment, patients in both group undergo IVF treatment. IVF treatment will then be performed for all patients, according to the current hospital treatment protocols.
Patients will be followed up until 7th week of gestation, if they have positive pregnancy test after embryo transfer.
Data Analysis and Statistics:
The investigators use Statistical Package for the Social Sciences (SPSS) software 20th version to analyze data. The primary end-point mean of number of retrieved oocytes will be compared between two groups using the Student's t test. The secondary end-points will also be compared between the 2 groups using either the Student's t test or chi-square test.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Testosterone gel | Active comparator | Drug: Testosterone gelTestosterone gel 10mg, used transdermally, once a day. Treatment duration: 6-8 weeks |
| DHEA | Active comparator | Drug: DHEADHEA 25mg tablet, orally, three times per day. Treatment duration: 6-8 weeks |
Who may qualify
- Ages
- 18 to 42 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- To be eligible for enrolment into this trial, each female subject must fulfill all of the following criteria at the start of enrolment, unless specified otherwise:
- Had one or two previous failure IVF cycle, using GnRH antagonist protocol (≥ 300 IU FSH/hMG per day) and the number of retrieved oocytes are ≤ 3;
- Antral follicle counts (AFC) < 6 or Anti-Mullerian Hormone (AMH) < 1.26 ng/ml
Key exclusion criteria (6 listed)
- To be eligible for enrolment in this study each subject must not meet any of the following criteria:
- Oocyte donation cycle
- Patients have thyroid disease
- Patients have liver or kidney dysfunction
- Patients have abnormal puberty or genital development.
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: AndrogelApply 10mg testosterone gel to the abdomen and rub on with one finger, once a day, in the morning, then allow sites to dry and cover with clothing. Continue the treatment for 6-8 weeks until next IVF treatment. | Drug | Testosterone gel |
| DHEAAlso: DHEA tabletTake DHEA 25mg tablet orally, three times per day. Continue the treatment for 6-8 weeks, until next IVF treatment. | Drug | DHEA |
Primary outcome
Number of oocytes
Time frame: 30 minutes after oocyte retrieval completed
Number of oocytes retrieved Number of oocytes retrieved
1 secondary outcome
Clinical pregnancy
Time frame: 7 weeks after embryo transfer
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2017.
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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.
Linh P Tran, MD study director
Research Center for Genetics and Reproductive Health
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 gel and DHEA in people with Infertility, run by Vietnam National University at 1 site in Vietnam.
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 3 inclusion and 6 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: withdrawn, as of the sponsor's last update on 18 Apr 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 Vietnam. 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 was withdrawn before enrolling participants, so there are no results.
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?
Number of oocytes (time frame: 30 minutes after oocyte retrieval completed). 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 18 Apr 2017.