The goal of this clinical trial is to learn whether the sudden administration of vaginal micronized progesterone during the late follicular phase can trigger an LH surge and reactivation of oocyte meiosis in healthy oocyte donors aged 18 to 33 undergoing a mild ovarian stimulation cycle. The main question it aims to answer is:
* Does progesterone administered in the late follicular phase induce an LH surge and subsequent oocyte meiosis reactivation?
Participants will:
* Undergo a mild ovarian stimulation with 75 IU of follitropn alfa * Start vaginal micronized progesterone (400 mg every 12 hours) once at least one follicle reaches 15 mm * Have blood samples collected to measure hormone levels before and after progesterone administration * Undergo oocyte retrieval 35-36 hours after the progesterone trigger
This is a low-intervention, single-center pilot study including approximately 10 oocyte donors.
Informed Consent Form dated and signed correctly prior to the performance of any study procedure.
Oocyte donors aged >17 and <34 years old in the moment of the recruitment.
Patients with regular menstrual cycles (between 25 to 35 days long).
Generally healthy women with no history of endocrine disorders (e.g., polycystic ovary syndrome (PCOS) or significant systemic disease).
Presence of ovarian cyst(s) detected on the baseline (initial) ultrasound examination.
Untreated endocrine conditions (polycystic ovary syndrome (PCOS), uncontrolled thyroid dysfunction and hyperprolactinemia).
Hypogonadotropic or hypergonadotropic hypogonadism.
Known hypersensitivity or clinical contraindication to the administration of vaginal progesterone or its excipients. This includes, but is not limited to: active deep vein thrombosis or thromboembolic disorders, known or suspected estrogen- or progesterone-dependent neoplasia, undiagnosed abnormal genital bleeding, porphyria, or severe hepatic dysfunction. Additionally, patients with anatomical abnormalities of the vagina that preclude the proper insertion or absorption of the vaginal insert are excluded.
Single group
Vaginal micronized progesterone
DrugThis intervention consists of administering vaginal micronized progesterone at a dose of 400 mg every 12 hours to induce final oocyte maturation. The intervention is initiated once at least one follicle reaches a diameter of 15 mm during controlled ovarian stimulation with recombinant FSH. Progesterone administration continues until the morning of oocyte retrieval.
Number of mature oocytes
The number of mature oocytes obtained during the oocyte retrieval procedure. Retrieved follicular aspirates will be examined to identify and isolate cumulus-oocyte complexes, which will be assessed for maturity according to standard embryology laboratory procedures. The count of mature oocytes reflects oocyte meiosis reactivation following progesterone-induced ovulation triggering.
Endocrinological profile (E2, P4, FSH, LH)
Serum hormone levels (estradiol, progesterone, FSH and LH) collected via blood sample (as part of standard clinical practice)
Endocrinological profile (E2, P4, FSH, LH)
Serum hormone levels (estradiol, progesterone, FSH and LH) collected via blood sample (as part of standard clinical practice)
Total number of oocytes retrieved
The total number of oocytes retrieved during the transvaginal oocyte aspiration procedure are counted. Oocyte retrieval is conducted according to routine clinical practice.
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Instituto Valenciano de Infertilidade de Lisboa
Lead sponsor
Theramex
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
