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New treatment option for Infertility, Female
Official title Usefulness of Corifollitropin α as Alternative to Conventional Daily rFSH Protocols in Oocyte Donors Undergoing Pituitary Suppression With Medroxiprogesterona Acetate (MPA)
ClinicalTrials.gov ID: NCT06193135
What this study is testing
What is Corifolitropin Alfa?
Corifolitropin Alfa is an investigational medicine, given as an once-daily injection under the skin, being studied as a potential treatment for infertility, female.
Also referred to as ELONVA.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- IVF patients frequently experience physical, emotional or physicological burden; this is particularly relevant in the case of oocyte donors, since young women undergo a procedure that is of no health benefit to them. One of the phases of the treatment that contributes most to this situation is ovarian stimulation; as it involves the administration of daily injections which, in addition to the discomfort of administration, causes anxiety to the patient about its correct administration and possible side effects and to physicians concerns about patient compliance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 35, women only
You may be able to join if
- Signature of the subject's informed consent prior to any trial-related activity.
- Age between 18 and 35 years (both inclusive).
- Regular menstrual cycle, from 25 to 35 days (both inclusive).
- Absence of physical and psychological illness at the time of donation at the discretion of the investigator.
- BMI 18-28 kg/m2 (both inclusive) at the time of donation.
You likely can't join if
- Concurrent participation in another clinical trial.
- Previous participation in this clinical trial.
- Use of long-term hormonal contraception (hormonal IUD or subcutaneous implants) at least 1 month prior to enrollment.
- Any systemic or metabolic disorder (i.e.: diabetes...) that contraindicates the use of gonadotropins.
- Personal history of thrombophlebitis and thromboembolic phenomena and hypertension.
- Severe hepatic insufficiency, cardiovascular disease
See the full eligibility criteria
- Signature of the subject's informed consent prior to any trial-related activity.
- Age between 18 and 35 years (both inclusive).
- Regular menstrual cycle, from 25 to 35 days (both inclusive).
- Absence of physical and psychological illness at the time of donation at the discretion of the investigator.
- BMI 18-28 kg/m2 (both inclusive) at the time of donation.
- No personal or family history of interest at the discretion of the investigator.
- Normal uterus and ovaries, without organic pathology.
- No polycystic ovaries.
- Antral follicle count greater than 12 in the sum of the two ovaries at the time of the screening visit.
- Normal karyotype.
- Negative infectious disease screening (Hepatitis B Virus, Hepatitis C Virus, Human Immunodeficiency Virus and Syphilis).
- General analysis with hemogram, hemostasis and biochemistry with parameters within normality.
- Concurrent participation in another clinical trial.
- Previous participation in this clinical trial.
- Use of long-term hormonal contraception (hormonal IUD or subcutaneous implants) at least 1 month prior to enrollment.
- Any systemic or metabolic disorder (i.e.: diabetes...) that contraindicates the use of gonadotropins.
- Personal history of thrombophlebitis and thromboembolic phenomena and hypertension.
- Severe hepatic insufficiency, cardiovascular disease
- Suspicion or evidence of breast malignancy or hormone-dependent genital organs.
- Known hypersensitivity to AMP or its excipients
- Any reason for exclusion from the oocyte donation program.
The study team makes the final eligibility decision.
Where it's taking place
- Valencia, Valencia, Spain
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years to 35 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Valencia, Valencia, Spain. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.