Testosterone transdermal gel for poor ovarian responders trial
Testosterone and ovarian response
Ovarian insufficiency reduces the chances of a successful IVF/ICSI treatment. The lower the ovarian reserve, the lower the reaction to stimulation medication.
Recent studies show that androgen supplementation in patients with a low ovarian reserve increases the number of follicles and increases the chances of pregnancy. Androgens should be administered at least 2 months before the start of ovarian simulation to have an effect.
This “T-transport” is a randomised and controlled trial conducted at different centres. It evaluates the effect of the administration of 0.55gr transdermal testosterone gel with 5.5mg testosterone a day in poor ovarian responders.
Administration is in the two months before ovarian stimulation in the IVF|ICSI treatment protocol which we know as “the long procedure with agonists”. In this treatment protocol, ovarian stimulation is preceded by suppression for two to three weeks of the natural cycle.
How can I participate in this trial?
Following your initial consultation with the fertility doctor you will be asked to have blood tests and an ultrasound examination. Based on the results and the results of the previous stimulated cycles the doctor can determine whether you are eligible.
If so, the study nurses will counsel you free of charge and ask you if you want to participate. If you agree to take part in the study, you will be asked to sign an informed consent form and to confirm you have been sufficiently informed about the organisation and course of the trial. You will be randomised into one of two groups: one group receives the testosterone, the other a placebo.
What does participation in the trial imply?
Participation in the trial means you have to apply a gel on your thigh every day before you start IVF/ ICSI treatment. You will also be asked to complete several questionnaires and to perform 4 additional blood tests over the course of the study.
Do I have to pay any extra fees for participation?
Participation in the study is free and the additional visits will not be charged to you. The gel is also free of charge.
How does this treatment protocol differ from my previous IVF attempts?
This protocol is exactly the same as the “long procedure with agonists”, using the highest dose of gonadotrophins (for the ovarian stimulation). The only difference lies in the fact that for two months you need to apply a gel to your thigh before you can start treatment. Thus, there is no substantial delay in starting your stimulation.
What are the possible benefits from my participation in the trial?
After treatment there might be an increase in the number of follicles and the number of picked up eggs. It may increase your chances of pregnancy.
You have a 50% chance of receiving testosterone gel, however, no one (neither you, nor your doctor or the nurses) will know whether you are receiving testosterone or a placebo.
On the other hand, your stimulation will not differ from the main protocol used in poor ovarian responders at our centre. Even if you don’t receive testosterone, you can count on a high-quality treatment cycle, with accurate monitoring, aimed at the best possible response.