Study on Infertility: Comparing Corifollitropin Alfa and Follitropin Beta for Women Undergoing Elective Fertility Preservation

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What is this study about?

This clinical trial is focused on studying infertility and involves a treatment approach for women who are preserving their fertility. The study is comparing two different methods of stimulating the ovaries to produce mature eggs. The first method involves two doses of a medication called Corifollitropin Alfa (CFA), while the second method uses one dose of CFA followed by daily doses of another medication called recombinant Follicle Stimulating Hormone (rFSH). These medications are used to help the ovaries produce more eggs, which can then be collected and preserved for future use.

The purpose of the study is to compare the number of mature eggs retrieved using these two different methods. Participants will receive either the two doses of CFA or the combination of CFA and rFSH. The study will also look at other factors, such as the total number of eggs collected, hormone levels on the day of egg collection, and any side effects like Ovarian Hyperstimulation Syndrome (OHSS), which is a condition where the ovaries become swollen and painful. Additionally, participants will complete a quality of life questionnaire to assess their experience during the study.

The study will take place over a period of time, with participants undergoing the treatment and monitoring process. This includes receiving the medications, attending appointments for blood tests, and having the eggs collected. The goal is to determine which method is more effective in helping women preserve their fertility by producing a higher number of mature eggs.

1 joining the study

Upon joining the study, eligibility is confirmed based on specific criteria such as age, body mass index, and hormone levels.

Participants must be between 18 and 40 years old, with a body mass index greater than 18 and less than 30 kg/m².

2 initial medication administration

The first step involves the administration of corifollitropin alfa (CFA) through a subcutaneous injection.

This medication is provided as either Elonva 100 micrograms or Elonva 150 micrograms solution for injection.

3 daily medication regimen

Following the initial CFA injection, participants may receive daily doses of recombinant follicle-stimulating hormone (rFSH) for ovarian stimulation.

The rFSH is administered as Puregon 900 IU/1.08 ml solution for injection.

4 ovarian stimulation monitoring

Participants undergo regular monitoring to assess the response to ovarian stimulation.

This includes blood tests and ultrasound examinations to evaluate hormone levels and follicle development.

5 final oocyte maturation

The final stage involves triggering oocyte maturation using a GnRH-agonist (GnRH-a) such as Decapeptyl diario 0.1 mg solution for injection.

This step is crucial for preparing the oocytes for retrieval.

6 oocyte retrieval

Oocytes are retrieved following the final maturation trigger.

The primary goal is to compare the number of mature oocytes retrieved between different medication protocols.

7 post-retrieval assessment

Participants complete a quality of life questionnaire called FertiQoL to assess the impact of the trial on their well-being.

The incidence of ovarian hyperstimulation syndrome (OHSS) is also monitored.

Who Can Join the Study?

  • The study is for women only.
  • Participants must be between 18 and 40 years old.
  • Participants should have a Body Mass Index (BMI) greater than 18 and less than 30. BMI is a measure of body fat based on height and weight.
  • Participants must have an Antral Follicle Count (AFC) of 20 or less. AFC is a test that counts the number of small follicles in the ovaries.
  • Participants should have an Anti-Mullerian Hormone (AMH) level of 3 ng/ml or less. AMH is a hormone that helps to estimate the number of eggs left in the ovaries.
  • Participants must be able to visit the study center for necessary procedures like blood tests, appointments, and receiving medication.

Who Cannot Join the Study?

  • Patients who are not experiencing infertility cannot participate.
  • Only female patients are eligible; male patients cannot participate.
  • Patients who are part of a vulnerable population, such as those who may not be able to give informed consent, cannot participate.

Where you can join this trial?

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Verified Sites

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Other Sites

Site Name City Country Status
Hospital Universitari Dexeus Grupo Quironsalud Barcelona Spain

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Spain Spain
Not recruiting
02.10.2023

Trial locations

Corifollitropin alpha (CFA) is a medication used to stimulate the ovaries to produce multiple eggs in women undergoing fertility treatments. It is given as an injection and works by mimicking the natural hormones in the body that control the growth and release of eggs from the ovaries.

Recombinant Follicle Stimulating Hormone (rFSH) is another medication used in fertility treatments to stimulate the ovaries. It is also given as an injection and helps in the development of multiple eggs. In this trial, rFSH is used after the initial administration of Corifollitropin alpha to enhance the ovarian stimulation process.

Infertility – Infertility is a condition where an individual or couple is unable to conceive a child after a year of regular, unprotected sexual intercourse. It can affect both men and women and may result from various factors, including hormonal imbalances, structural problems, or issues with sperm or egg production. In women, infertility can be related to ovulation disorders, blocked fallopian tubes, or uterine abnormalities. In men, it often involves low sperm count, poor sperm motility, or blockages that prevent sperm delivery. The condition can be temporary or permanent, depending on the underlying cause. Infertility can lead to emotional stress and may require medical intervention to achieve pregnancy.

Trial ID:
2023-506162-31-00
Protocol code:
FSD-SEQ-2023-09
Trial Phase:
Therapeutic confirmatory (Phase III)

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