Exogenous Progesterone as Ovulation Trigger

NCT07466199 | Not Yet Recruiting Phase 4

• 1 other identifier: 2504-LIS-054-AN
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hormonal Response; Ovulation; Ovarian Function; Assisted Reproductive Treatments; Oocyte Maturation

Keywords

Trigger; Oocyte Donation; Progesterone; Oocyte Maturation; Luteinizing Hormone; LH Surge; Oocyte Retrieval; Oocyte Meiosis; Late Follicular Phase; Endocrinological profile

Outcome Measures

Primary Outcomes (1)

• 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.

  35-36 hours after progesterone initiation

Secondary Outcomes (3)

• Endocrinological profile (E2, P4, FSH, LH)

  12 hours after progesterone initiation

• Endocrinological profile (E2, P4, FSH, LH)

  35-36 hours after progesterone initiation

• Total number of oocytes retrieved

  35-36 hours after progesterone initiation

Study Arms (1)

Oocyte donors

EXPERIMENTAL

This arm includes 10 healthy oocyte donors undergoing an ovarian stimulation cycle with 75 IU of recombinant FSH, followed by progesterone-induced ovulation triggering. All participants receive recombinant FSH starting on cycle days 1-3, following spontaneous mentsrual bleeding. Once at least one follicle reaches 15 mm, final oocyte maturation is induced with vaginal micronized progesterone 400 mg every 12 hours. Hormonal monitoring and ultrasound assessments are performed as part of standard care. Oocyte retrieval is performed 35-36 hours after "progesterone-induced ovulation triggering" by transvaginal aspiration. Progesterone will be kept until the morning of the day of oocyte retrieval.

Drug: Vaginal micronized progesterone

Interventions

Vaginal micronized progesterone DRUG

This 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.

Also known as: Cyclogest® 400 mg

Oocyte donors

Eligibility Criteria

• Age: 18 Years - 33 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

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.

Sponsors & Collaborators

• Instituto Valenciano de Infertilidade de Lisboa: lead
• Theramex: collaborator

Study Sites (1)

Instituto Valenciano de Infertilidade (IVI Lisboa)

Lisbon, 1800-282, Portugal

Location

MeSH Terms

Interventions

Progesterone

Intervention Hierarchy (Ancestors)

Pregnenediones; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Corpus Luteum Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Progesterone Congeners; Gonadal Steroid Hormones

Study Officials

• Ana Raquel Neves

  Instituto Valenciano de Infertilidade (IVI Lisboa)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ana Raquel Neves

CONTACT

+351 218 503 210; Ana.Neves@ivirma.com

Belisa Silva

CONTACT

+351 218 503 210; Belisa.Silva@ivirma.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Model Details: This study uses a single-group including 10 oocyte donors. All participants follow the same ovarian stimulation protocol and receive vaginal micronized progesterone as the triggering intervention. Progesterone administration is initiated once at least one follicle reaches 15 mm. Hormonal monitoring and ultrasound assessments are performed as part of standard care, and oocyte retrieval takes place 35-36 hours after progesterone initiation. There is no control or comparison group; the study is designed as a proof-of-concept evaluation of progesterone as an ovulation trigger.

Study Record Dates

• First Submitted: March 6, 2026
• First Posted: March 12, 2026
• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: June 4, 2026

Record last verified: 2026-06

Locations

PT (1)