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Usefulness of Corifollitropin ฮฑ as Alternative to Conventional Daily rFSH Protocols in Oocyte Donors Undergoing Pituitary Suppression With Medroxiprogesterona Acetate (MPA)

RecruitingNAAges 18 Years - 35 YearsFemaleInstituto Valenciano de Infertilidad, IVI VALENCIA
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In plain words

What the trial is, and whether it could suit you

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. Advances in pharmacology and knowledge of ovarian pathophysiology have led to the development of new protocols that simplify and reduce drug administration, decrease the potential risk of misapplication and contribute to an improved patient experience. In this context, Corifollitropin ฮฑ, a long-acting recombinant FSH (rFSH) molec

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๐Ÿ“‹ Eligibility rules (as published)
Inclusion 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. Exclusion Criteria: * 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.
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What it tests

  • Corifolitropin Alfa
  • Folitropin Beta
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Where

2 sites
IVI Valencia
Valencia, Spain
Ivi Valencia
Valencia, Spain
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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