Exogenous progesterone as ovulation trigger – a pilot study

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Instituto Valenciano De Infertilidade Clinica De Reproducao Assistida Lda.

Participant type

Healthy volunteers

Age range

18-64 years

Gender

Female

Therapeutic area

Diseases [C] - Female Urogenital Diseases and Pregnancy Complications [C13]

Decision date (initial)

2026-05-22

Transition trial

No

Low-intervention

Yes

Rare-disease indication

No

Vulnerable population

No

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy

To ascertain whether the exogenous administration of progesterone during the late follicular phase may trigger oocyte meiosis reactivation .

Secondary objectives 2

1. To analyze the endocrinological profile (E2, P4, FSH and LH) 12h after progesterone initiation
2. To analyze the endocrinological profile (E2, P4, FSH, LH) on the day of oocyte retrieval.

Conditions and MedDRA coding

Infertility

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 5

1. Informed Consent Form dated and signed correctly prior to the performance of any study procedure.
2. Oocyte donors aged >17 and <34 years old in the moment of the recruitment.
3. Patients with regular menstrual cycles (between 25 to 35 days long).
4. Generally healthy women with no history of endocrine disorders (e.g., polycystic ovary syndrome (PCOS) or significant systemic disease).
5. Body Mass Index (BMI) between 18.5 and 28.

Exclusion criteria 7

1. Presence of ovarian cyst(s) detected on the baseline (initial) ultrasound examination.
2. Untreated endocrine conditions (polycystic ovary syndrome (PCOS), uncontrolled thyroid dysfunction and hyperprolactinemia).
3. Hypogonadotropic or hypergonadotropic hypogonadism.
4. 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.
5. 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.
6. 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.
7. Participation in any other ongoing clinical trial or use of investigational drugs within the last 30 days.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Number of mature oocytes (MII) following progesterone-induced oocyte maturation.

Secondary endpoints 2

1. Endocrinological profile (E2, P4, LH and FSH) 12h after trigger
2. Endocrinological profile (E2, P4, LH and FSH) on the morning of egg retrieval

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Instituto Valenciano De Infertilidade Clinica De Reproducao Assistida Lda.

Sponsor organisation

Instituto Valenciano De Infertilidade Clinica De Reproducao Assistida Lda.

Address

Avenida Infante Dom Henrique 333 H Esquerdo N. 1

City

Lisbon

Postcode

1800-282

Country

Portugal

Scientific contact point

Organisation

Instituto Valenciano De Infertilidade Clinica De Reproducao Assistida Lda.

Contact name

Ana Raquel Neves

Public contact point

Organisation

Instituto Valenciano De Infertilidade Clinica De Reproducao Assistida Lda.

Contact name

Ana Raquel Neves

Locations

1 EU/EEA country · 1 investigational sites

By country

Investigational sites

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 7 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

1 submissions — initial application plus substantial / non-substantial modifications