Exogenous Progesterone as Ovulation Trigger

Starting soon · Phase 4

Conditions studied: Ovulation, Ovarian Function, Assisted Reproductive Treatments, Oocyte Maturation, Hormonal Response

In brief

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.

Key facts

Study ID

NCT07466199

Run by

Instituto Valenciano de Infertilidade de Lisboa

People needed

10

Starts

2026-07-01

Expected to finish

2026-08-01

Last updated by the study team

2026-06-04

Who can join

Age: 18 and older, up to 33. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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).
• Body Mass Index (BMI) between 18.5 and 28.

You may not qualify if…

• 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.
• Any condition contraindicating vaginal ultrasound and/or vaginal oocyte retrieval.These include: active pelvic inflammatory disease (PID), acute vaginal or cervical infection, or presence of pelvic malignancies. Patients with significant anatomical distortions or vascular anomalies in the pelvic region that, in the investigator's opinion, would make oocyte retrieval technically unfeasible or pose an unacceptable risk of hemorrhage or injury to adjacent organs, are also excluded.
• Use of hormonal contraceptives (oral, patch, or ring) or GnRH analogues within the month preceding the study. Note: Participants who have discontinued these or other prohibited medications for a period of at least 30 days are eligible for rescreening starting at Visit 1.
• Participation in any other ongoing clinical trial or use of investigational drugs within the last 30 days.

Where it is running

• Instituto Valenciano de Infertilidade (IVI Lisboa) — Lisbon, Portugal

Full record on ClinicalTrials.gov

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