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Exogenous Progesterone as Ovulation Trigger

NCT07466199 · Status: NOT_YET_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2026-06-04

No results posted yet for this study

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

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

Interventions

DRUG

Vaginal micronized progesterone

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.

Sponsors & Collaborators

  • Theramex

    collaborator INDUSTRY

  • Instituto Valenciano de Infertilidade de Lisboa

    lead NETWORK

Principal Investigators

  • Ana Raquel Neves · Instituto Valenciano de Infertilidade (IVI Lisboa)

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
33 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-07-31
Primary Completion
2026-08-31
Completion
2026-08-31

Countries

  • Portugal

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07466199 on ClinicalTrials.gov