Study on the Effect of Lutropin Alfa to Improve Ovarian Reserve in Patients Undergoing IVF/ICSI Due to Tubal, Male Factor, or Unexplained Infertility

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What is this study about?

This clinical trial is focused on helping women who are undergoing in vitro fertilization (IVF) or intracytoplasmic sperm injection (ICSI) due to issues like blocked fallopian tubes, male infertility, or unexplained infertility. The study is testing a treatment called Luveris, which contains a substance known as lutropin alfa. This treatment is given as an injection under the skin and is designed to improve the number of eggs that can be developed in the ovaries.

The purpose of the study is to see if taking lutropin alfa at a dose of 187.5 international units (IU) each day for 60 days can increase the ovarian reserve, which is the number of eggs available in the ovaries. This is measured by checking the levels of a hormone called anti-Müllerian hormone (AMH) in the blood. The study will also look at other factors like the number of eggs that can be developed after 30 and 60 days, the response of the ovaries to the treatment, and the safety of using lutropin alfa.

Participants in the study will receive either the lutropin alfa treatment or a placebo. The study will monitor various outcomes, including the success of embryo transfers, pregnancy rates, and any potential side effects. The goal is to gather information that could help improve fertility treatments for women facing challenges in conceiving.

1 joining the study

Upon joining the study, eligibility is confirmed based on specific criteria such as age, hormone levels, and willingness to participate.

Informed consent is required to proceed with the study.

2 pre-treatment phase

The pre-treatment involves administering rhLH (recombinant human luteinizing hormone) at a dose of 187.5 IU per day.

This medication is given as a subcutaneous injection for a duration of 60 days.

The goal of this phase is to improve ovarian reserve, which is measured by an increase in basal AMH (anti-Müllerian hormone) levels.

3 monitoring and assessment

Throughout the pre-treatment phase, regular monitoring is conducted to assess changes in AFC (antral follicle count) and AMH levels.

Safety evaluations of the treatment are also performed during this period.

4 completion of pre-treatment

After 60 days of pre-treatment, a final assessment of ovarian reserve is conducted.

The primary endpoint is to confirm the improvement in ovarian reserve as indicated by increased basal AMH levels.

5 follow-up and outcomes

Secondary outcomes such as ovarian response, pregnancy rates, and safety are evaluated.

The study also tracks various pregnancy-related outcomes, including implantation rate, miscarriage rate, and birth outcomes.

Who Can Join the Study?

Patients must be admitted to an IVF/ICSI cycle. This means they are undergoing a process to help with fertility.
The reasons for being in the IVF cycle can be due to issues with the fallopian tubes, male fertility problems, or unexplained infertility.
Patients need to have an AFC (Antral Follicle Count) of at least 5. This is a count of small follicles in the ovaries, checked within 3 months before the study.
Patients should have basal AMH (Anti-Müllerian Hormone) levels of at least 1 ng/ml, measured within 3 months before the study. This hormone helps assess the ovarian reserve.
Patients must be between the ages of 25 and 38 at the time of the study.
D3 Basal LH (Luteinizing Hormone) levels should be between 1-6 IU/L, checked within 3 months before the study. This hormone is important for reproductive health.
D3 Basal FSH (Follicle-Stimulating Hormone) levels should be less than 8 IU/L, measured within 3 months before the study. This hormone helps control the menstrual cycle and egg production.
D3 Estradiol levels should be less than 70 pg/ml, checked within 3 months before the study. Estradiol is a form of estrogen, a female hormone.
Patients must be willing to participate in the study.
Patients should be able to understand and follow the study procedures.
Patients should be eumenorrheic, meaning they have regular menstrual cycles, and have low LH levels. They should be candidates for IVF/ICSI due to tubal issues, male factors, or unexplained infertility.
Patients must accept and sign the informed consent, which is a document explaining the study and confirming their agreement to participate.

Who Cannot Join the Study?

Patients who are not admitted to an IVF/ICSI cycle cannot participate. IVF/ICSI are medical procedures to help with pregnancy.
Patients who are not female cannot participate.
Patients who are not within the specified age range cannot participate. The age range is not specified here, but it is important for eligibility.
Patients who are part of a vulnerable population cannot participate. A vulnerable population includes groups who may need special protection or care.

Where you can join this trial?

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Other Sites

Site Name	City	Country
Azienda Ospedaliero Universitaria Di Modena	Modena	Italy
Ospedale San Raffaele S.r.l.	Milan	Italy
Atxhfoh Oqwuudtayyl Ufqustrgmetyq Clijtipxprhy Dtvic Sqqcyy E Ddycf Swttmxm Dm Tgcree	Turin	Italy

Trial status

Country	Status	Recruitment Start
Italy	Recruiting	01.01.2025

Trial locations

Investigated drugs:

Lutropin Alfa

rhLH is a medication used in this trial to improve ovarian reserve. It is a form of luteinizing hormone that is administered to help increase the number of recruitable antral follicles in the ovaries. This treatment aims to enhance fertility by boosting the levels of a hormone that plays a crucial role in the reproductive process.

Infertility – Infertility is a condition where a person is unable to conceive after a year of regular, unprotected intercourse. It can be due to various factors, including issues with the reproductive system of either partner. In women, it may be caused by problems such as blocked fallopian tubes or hormonal imbalances. In men, it can result from low sperm count or poor sperm motility. Sometimes, the cause of infertility is unknown, which is referred to as idiopathic infertility. The condition can lead to emotional stress and requires medical evaluation to determine the underlying cause.

Trial ID:

2024-517407-36-00

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on the Effect of Lutropin Alfa to Improve Ovarian Reserve in Patients Undergoing IVF/ICSI Due to Tubal, Male Factor, or Unexplained Infertility

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?