Overview
Sponsor-declared trial summary
Female Infertility
to determine whether the use of letrozole during the luteal phase in oocyte donors diminishes the ovarian volume
Key facts
- Sponsor
- Ivi Madrid S.L., Ivi Madrid S.L.
- Participant type
- Healthy volunteers
- Age range
- 18-64 years
- Gender
- Female
- Therapeutic area
- Phenomena and Processes [G] - Reproductive and Urinary Physiological Phenomena [G08]
- Trial duration
- 4 Dec 2023 → 2 Jun 2025
- Decision date (initial)
- 2023-03-17
- Transition trial
- No
- Low-intervention
- Yes
- Rare-disease indication
- No
- Vulnerable population
- No
- Funding sources
- IVIRMA Madrid
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Therapy
to determine whether the use of letrozole during the luteal phase in oocyte donors diminishes the ovarian volume
Secondary objectives 1
- To determine the differences in the levels of VEGF, VEGF/sFlt-1 ratio, LH, FSH, oestradiol, progesterone and testosterone in the plasma of oocyte donors depending on whether or not they receive letrozole during the luteal phase after ovarian stimulation. To determine the differences in the duration of the luteal phase in oocyte donors depending on whether or not they receive letrozole during the luteal phase after ovarian stimulation
Conditions and MedDRA coding
Female Infertility
Study design 1 period
| # | Title | Allocation | Blinding | Roles blinded | Arms |
|---|---|---|---|---|---|
| 1 | Period title Description of trial design
|
Randomised Controlled | None | Treatment: Letrozol 5mg/day during 5 days Control: without treatment |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 1
- - Women who have been accepted into IVI's oocyte donation programme. - Age between 18 and 34 years, inclusive. - Hyperresponsiveness to stimulation, defined as the presence of ≥18 follicles of size ≥11 mm on the day of the last ultrasound control visit prior to ovarian puncture. - Dated and signed informed consent.
Exclusion criteria 1
- - Known allergy to letrozole. - Known lactose intolerance. - Participation in another clinical study, prior to inclusion in the present study, which could affect the objectives of the study in the opinion of the investigator.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- ovarian volume
Secondary endpoints 1
- Plasma values of VEGF, sFlt-1, oestradiol, progesterone, FSH, LH and testosterone
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
SCP236273 · ATC
- Active substance
- Letrozole
- Route of administration
- ORAL
- Max daily dose
- 5 mg milligram(s)
- Max total dose
- 5 mg milligram(s)
- Max treatment duration
- 10 Day(s)
- Authorisation status
- Authorised
- ATC code
- L02BG04 — LETROZOLE
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Ivi Madrid S.L.
- Sponsor organisation
- Ivi Madrid S.L.
- Address
- Avenida Talgo 68-70
- City
- Madrid
- Postcode
- 28023
- Country
- Spain
Scientific contact point
- Organisation
- Ivi Madrid S.L.
- Contact name
- Sergio Caballero
Public contact point
- Organisation
- Ivi Madrid S.L.
- Contact name
- Sergio Caballero
Ivi Madrid S.L.
- Sponsor organisation
- Ivi Madrid S.L.
- Address
- Avenida Talgo 68-70
- City
- Madrid
- Postcode
- 28023
- Country
- Spain
Locations
1 EU/EEA country · 2 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Spain | Ended | 152 | 2 |
| Rest of world | — | 0 | — |
Investigational sites
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Spain | 2023-12-04 | 2025-06-02 | 2023-12-15 | 2025-05-19 |
Application history
3 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2022-12-07 | Spain | Acceptable 2023-03-13
|
2023-03-17 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-05-07 | Spain | Acceptable 2024-06-18
|
2024-06-18 |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2024-06-25 | Spain | Acceptable 2024-06-18
|
2024-06-25 |