Study on the Effect of Ovarian Stimulation Intensity Using Clomifene Citrate and Follitropin Alfa in Women with Infertility and Suboptimal Response

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What is this study about?

This clinical trial is focused on studying infertility and aims to understand how different levels of ovarian stimulation affect the quality of embryos in women who are expected to have a suboptimal response to treatment. The study involves the use of several medications, including Ovaleap (which contains follitropin alfa, a hormone that helps stimulate the ovaries), Decapeptyl (which contains triptorelin, a hormone that helps control the release of other hormones), Utrogestan (which contains progesterone, a hormone that supports pregnancy), Omifin (which contains clomifene citrate, a medication that helps stimulate ovulation), Orgalutran (which contains ganirelix, a hormone that prevents premature ovulation), and Ovitrelle (which contains choriogonadotropin alfa, a hormone that triggers ovulation).

The purpose of the study is to compare two groups of women undergoing ovarian stimulation for in vitro fertilization (IVF). One group will receive a combination of clomifene citrate and 150 IU of follitropin alfa, while the other group will receive clomifene citrate and 300 IU of follitropin alfa. The study will monitor the number of good-quality blastocysts, which are early-stage embryos, according to specific criteria. Participants will receive the medications through injections or oral tablets over a period of up to 42 days, depending on the specific medication and treatment plan.

Throughout the study, various aspects of embryo development will be observed, such as the time it takes for embryos to reach different stages, including the appearance and disappearance of pronuclei (the initial stage of embryo development), division into multiple cells, and formation into a blastocyst. The study will also track the overall number of embryos and the rate at which blastocysts form. The goal is to gather information that could help improve treatment strategies for women experiencing infertility.

1 initial medication administration

Begin with the administration of clomifene citrate (Omifin 50 mg tablets) taken orally. This medication is used to stimulate the ovaries and is typically taken once daily for a specified number of days as directed by the healthcare provider.

2 ovarian stimulation

Receive follitropin alfa (Ovaleap) injections. The dosage may vary between 150 IU and 300 IU, depending on the assigned group. This medication is administered subcutaneously, which means it is injected under the skin. The frequency and duration of these injections will be determined by the healthcare provider.

3 ovulation suppression

Administer ganirelix (Orgalutran 0.25 mg/0.5 mL solution for injection) subcutaneously. This medication helps prevent premature ovulation during the stimulation phase.

4 final maturation of eggs

Receive an injection of choriogonadotropin alfa (Ovitrelle 250 micrograms/0.5 mL solution for injection in pre-filled syringe) subcutaneously. This injection is used to trigger the final maturation of the eggs before retrieval.

5 egg retrieval

Undergo a procedure to retrieve the mature eggs from the ovaries. This step is performed at a medical facility and involves a minor surgical procedure.

6 embryo development

The retrieved eggs are fertilized in a laboratory setting. The development of embryos is monitored, and the quality of the embryos is assessed according to specific criteria.

7 embryo transfer

Transfer the selected embryos into the uterus. This procedure is typically performed a few days after egg retrieval and does not require anesthesia.

8 supportive medication

Use progesterone (Utrogestan 200 mg capsules) vaginally. This medication supports the uterine lining and helps maintain a potential pregnancy.

9 monitoring and follow-up

Attend follow-up appointments to monitor the response to treatment and the development of the pregnancy, if applicable. The healthcare provider will provide specific instructions regarding the frequency and nature of these visits.

Who Can Join the Study?

Must be a woman experiencing infertility and undergoing treatment to stimulate the ovaries for IVF (In Vitro Fertilization).
Must have an AFC (Antral Follicle Count) between 5 and 10. This is a test that counts the small follicles in the ovaries.
Must have an AMH (Anti-Müllerian Hormone) level of 1.5 ng/ml or less. This hormone helps to estimate the number of eggs left in the ovaries. The test result is valid if done within the last year.
Must be between 35 and 40 years old.
Must have a BMI (Body Mass Index) greater than 18.5 and less than 25 kg/m². BMI is a measure of body fat based on height and weight.
Must be willing to participate in the study.

Who Cannot Join the Study?

Participants must not have any medical conditions that could interfere with the study.
Participants should not be taking any medications that could affect the study results.
Participants must not have any allergies to the medications used in the study.
Participants should not be pregnant or breastfeeding.
Participants must not have any history of drug or alcohol abuse.
Participants should not have any serious mental health conditions.
Participants must not have participated in another clinical trial recently.
Participants should not have any other health conditions that the study doctors think would make it unsafe for them to participate.

Where you can join this trial?

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Other Sites

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

Trial status

Country	Status	Recruitment Start
Spain	Not recruiting	06.07.2021

Trial locations

Investigated drugs:

Clomiphene Citrate (CC) is a medication used to stimulate the ovaries. It helps in the development of eggs in women who have difficulty ovulating. In this trial, it is used to enhance the response of the ovaries to produce more eggs.

Recombinant Follicle Stimulating Hormone (rFSH) is a hormone used to stimulate the ovaries to produce multiple eggs. It is often used in fertility treatments to increase the chances of successful fertilization. In this trial, it is used in combination with Clomiphene Citrate to assess its impact on embryo quality.

Investigated diseases:

Infertility

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 may be due 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:

2024-514322-23-00

Protocol code:

FSD-IEQ-2021-03

NCT ID:

NCT04983173

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on the Effect of Ovarian Stimulation Intensity Using Clomifene Citrate and Follitropin Alfa in Women with Infertility and Suboptimal Response

What is this study about?

Who Can Join the Study?

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