Study of testosterone gel treatment for women with low ovarian reserve and androgen receptor polymorphism undergoing fertility treatment

3 1 1 1

What is this study about?

This clinical trial investigates the effectiveness of testosterone treatment in women with low ovarian reserve who have a specific genetic variation in their androgen receptor. Low ovarian reserve is a condition where the ovaries have a reduced capacity to produce eggs, which can affect fertility. The study focuses on women who are preparing to undergo intracytoplasmic sperm injection, a fertility treatment where a single sperm is injected directly into an egg.

The main treatment being tested is Testogel, a gel that is applied to the skin and contains testosterone. This medication will be used before starting the fertility treatment. Additional medications used in the study include Decapeptyl, Bemfola, and Astarté, which are all given as injections under the skin to help stimulate and control egg production.

The purpose of this study is to determine if using testosterone gel before fertility treatment can increase the number of eggs collected during the procedure in women who have both low ovarian reserve and a specific genetic variation. The study will measure various aspects of fertility treatment success, including the number and quality of eggs obtained, how well the eggs develop after fertilization, and whether pregnancy occurs.

1 Initial treatment phase

The treatment begins with the application of Testogel, a gel that is applied to the skin (transdermal use). This medication contains testosterone.

The gel needs to be applied daily according to the prescribed dosage.

2 Ovarian stimulation initiation

After the testosterone pretreatment phase, you will start receiving daily injections of Decapeptyl (triptorelin) under the skin (subcutaneous injection).

The dose is 0.1 mg per day of Decapeptyl solution for injection.

3 Follicle stimulation phase

Bemfola (follitropin alfa) injections will be administered under the skin. The starting dose is 300 IU using a pre-filled injection pen.

These injections help stimulate the development of egg follicles in the ovaries.

4 Prevention of premature ovulation

Astarté (ganirelix) will be administered via subcutaneous injection at a dose of 0.25 mg.

This medication prevents early release of eggs before the optimal time for collection.

5 Egg collection procedure

Once the follicles reach the appropriate size, the eggs will be collected through a medical procedure.

The collected eggs will be evaluated in the laboratory to determine their maturity and quality.

6 Fertilization and embryo development

The collected eggs will undergo intracytoplasmic sperm injection (ICSI), a procedure where a single sperm is injected directly into each mature egg.

The fertilized eggs will be monitored for development to the blastocyst stage (advanced embryo stage).

Who Can Join the Study?

Meet at least two of these conditions for low ovarian reserve:
– Age 40 or older
– Previous fertility treatment with fewer than 4 eggs retrieved
– Low ovarian reserve test results (antral follicle count less than 5-7 or AMH less than 0.5-1.1 ng/ml)
Have a specific genetic variation in the androgen receptor (between 22 and 24 CAG repeats)
Have a Body Mass Index (BMI) less than 32 (a measure of body weight relative to height)
Need in vitro fertilization treatment (a fertility treatment where eggs are fertilized outside the body)
Have both ovaries present
Have no ovarian cysts (fluid-filled sacs on the ovaries)
Have no endometriosis (a condition where uterine tissue grows outside the uterus)
Have normal results for karyotype (chromosome analysis) and fragile X testing (a genetic condition test)
Not have severe male fertility problems
Have sperm available from ejaculation
Be able to follow all study requirements
Provide written consent to participate

Who Cannot Join the Study?

Age below 18 or above 40 years
Male patients (study is for female participants only)
Patients who do not meet the Bologna criteria for low ovarian reserve (a medical standard that measures a woman’s egg supply)
Patients who are not carriers of androgen receptor polymorphism (a specific genetic variation related to hormone receptors)
Patients currently participating in other clinical trials
Patients who are pregnant or breastfeeding
Patients with contraindications to testosterone treatment (medical conditions that make the use of testosterone unsafe)
Patients with known allergies to the study medications
Patients with severe medical conditions that could interfere with the study procedures
Patients unable to provide informed consent
Patients with history of adverse reactions to hormone treatments
Patients with conditions that could affect hormone metabolism

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

No sites found in this category

Other Sites

Site Name	City	Country	Status
Izsmtdykq Bjlqgrvf Pmkjr Df Mnawtlgw Sjzg	Palma	Spain
Ishryqkbt Bxgxeixe Slww	Alicante	Spain

Trial status

Country	Status	Recruitment Start
Spain	Not yet recruiting	31.01.2024

Trial locations

Investigated drugs:

Transdermal testosterone
This is a hormone medication that is applied to the skin (transdermal). It is used to increase testosterone levels in the body. In this trial, it is being tested as a pretreatment for women with low ovarian reserve before they undergo fertility treatment. The medication is designed to potentially improve the number of eggs that can be retrieved during the fertility procedure.

Intracytoplasmic sperm injection (ICSI)
This is not a medication but a specialized fertility treatment procedure where a single sperm is directly injected into an egg in the laboratory. It is used as part of in vitro fertilization (IVF) treatment to help achieve pregnancy, particularly in cases where there are fertility challenges.

Investigated diseases:

Infertility female

Low Ovarian Reserve – A condition where a woman’s ovaries have a reduced number and quality of eggs compared to what is expected for her age. This condition affects the reproductive potential and is characterized by diminished ovarian response to hormonal stimulation. The ovaries show decreased ability to produce eggs that can result in pregnancy. Low ovarian reserve can be determined through specific medical criteria, including hormone levels and ultrasound findings. This condition may occur naturally with aging or can develop earlier in some women.

Androgen Receptor Polymorphism – A genetic variation that affects how the body responds to androgens (male hormones). This condition involves changes in the androgen receptor gene, which can alter how cells respond to hormones like testosterone. The polymorphism can affect various bodily functions and processes where androgens play a role. These genetic variations can influence reproductive function and hormone sensitivity in both men and women.

Trial ID:

2024-510596-37-00

NCT ID:

NCT06195163

Trial Phase:

Therapeutic confirmatory (Phase III)

Other Trials to Consider

#1 Clinical Trials Search in Europe

Study of testosterone gel treatment for women with low ovarian reserve and androgen receptor polymorphism undergoing fertility treatment

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?