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Study on the Effects of Low Dose Choriogonadotropin Alfa in Women with Diminished Ovarian Reserve Undergoing IVF/ICSI

Verified siteRegistered drugNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying a condition known as diminished ovarian reserve, which is a cause of infertility in women. The study will explore the effects of a treatment called low dose hCG priming in women undergoing IVF/ICSI (in vitro fertilization/intracytoplasmic sperm injection). The medication used in this study is called Ovitrelle, which contains the active substance choriogonadotropin alfa. This trial will compare the effects of this medication with a placebo to see if it can help increase the number of eggs retrieved during the IVF/ICSI process.

The purpose of the study is to examine whether using low dose hCG priming for eight weeks can improve outcomes for women with diminished ovarian reserve who are undergoing IVF/ICSI. The study will last for a period of time during which participants will receive either the medication or a placebo. The main focus will be on the number of eggs retrieved, but other factors such as the number of fertilized eggs, embryo quality, and pregnancy rates will also be observed.

Participants will receive the treatment through a subcutaneous injection, which means the medication is injected under the skin. The study aims to confirm findings from a previous pilot study that suggested a significant increase in the number of eggs retrieved could be achieved with this treatment. The trial will help determine if this approach can be beneficial for women facing challenges with fertility due to diminished ovarian reserve.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, you will be informed about the purpose and procedures involved. The study aims to examine the effects of low dose hCG priming for eight weeks in women with diminished ovarian reserve undergoing IVF/ICSI.

    You will be required to meet certain criteria, such as being between 18 and 40 years old, having a regular menstrual cycle, and having specific hormone levels.

  2. Step 2

    Medication administration

    You will receive a medication called Ovitrelle, which contains choriogonadotropin alfa. This medication is administered as a subcutaneous injection, meaning it is injected under the skin.

    The dosage is 250 micrograms per 0.5 mL solution, provided in a pre-filled syringe. This medication will be administered over a period of eight weeks.

  3. Step 3

    Monitoring and assessments

    Throughout the trial, regular monitoring will be conducted to assess your response to the medication. This includes measuring the number of eggs retrieved, hormone levels, and other relevant factors.

    Additional assessments may include counting the number of follicles, evaluating the quality of embryos, and tracking pregnancy and live birth rates.

  4. Step 4

    Completion of the trial

    At the end of the eight-week period, a final evaluation will be conducted to determine the outcomes of the treatment.

    The primary focus will be on the number of eggs retrieved, while secondary outcomes will include various reproductive health indicators.

Who can join the trial?

5 criteria

  • Must be female.
  • Age between 18 and 40 years old, including both ages.
  • Have a regular menstrual cycle that lasts between 23 and 35 days.
  • Currently undergoing the 1st to 5th IVF/ICSI cycle at the time of joining the study. IVF/ICSI are treatments to help with fertility.
  • Have an AMH level of less than 6.29 pmol/L. AMH (Anti-Müllerian Hormone) is a hormone that helps to understand the number of eggs a woman has.

Who cannot join the trial?

4 criteria

  • Women who are not experiencing infertility or do not have a diminished ovarian reserve cannot participate. Diminished ovarian reserve means having fewer eggs in the ovaries than expected for your age.
  • Men cannot participate in this study.
  • Individuals who are not within the specified age range for the study cannot participate. The study is for a specific age group of women.
  • Women who are part of a vulnerable population cannot participate. A vulnerable population includes groups who may need special protection or care.
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Investigated drugs

hCG is a hormone that is often used in fertility treatments. In this clinical trial, it is being used in a low dose to help women with a condition called diminished ovarian reserve. This condition means that the ovaries have fewer eggs than usual, which can make it harder to get pregnant. The hCG is given to the women for eight weeks before they undergo a procedure called IVF or ICSI, which are methods used to help with conception. The goal of using hCG in this way is to increase the number of eggs that can be retrieved from the ovaries, which could improve the chances of a successful pregnancy.

What is already known about the treatment

Human Chorionic Gonadotropin (hCG) – This medication is administered as an injection under the skin, commonly used in fertility treatments. It is currently being studied for its effects on women with diminished ovarian reserve undergoing in vitro fertilization (IVF) or intracytoplasmic sperm injection (ICSI). The main therapeutic use of hCG in this context is to improve the number of eggs retrieved during these procedures. At the molecular level, hCG works by mimicking the luteinizing hormone, which stimulates the ovaries to produce eggs. It is classified as a hormone therapy in pharmacology.

Investigated diseases

Infertility, diminished ovarian reserve – Diminished ovarian reserve (DOR) is a condition where the ovaries lose their normal reproductive potential, which can lead to infertility. It is characterized by a reduced number of eggs in the ovaries and often occurs as a woman ages. The condition can also be influenced by genetic factors, medical treatments, or surgeries that affect the ovaries. Women with DOR may experience irregular menstrual cycles or changes in menstrual flow. The progression of DOR can vary, but it generally involves a gradual decline in the quantity and quality of eggs. This condition can make it more challenging to conceive naturally.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2025-521234-28-00Estimated enrolment80 patientsSponsorRigshospitalet

sourced from the EU Clinical Trials Register and site verification

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