Intranasal nafarelin compared to subcutaneous triptorelin for triggering final oocyte maturation in ovarian stimulation: a non-inferiority randomised controlled clinical trial

2024-516621-31-00 Protocol FSD-NAF-2024-11 Therapeutic use (Phase IV) Authorised, recruitment pending

Status Authorised, recruitment pending · 1 EU/EEA countries · 5 sites · Protocol FSD-NAF-2024-11

Overview

Sponsor-declared trial summary

Phase Therapeutic use (Phase IV)
Status Authorised, recruitment pending
Participants planned 154
Countries 1
Sites 5

Infertility

To compare the number of metaphase II oocytes retrieved following triggering of final oocyte maturation with intranasal nafarelin compared to subcutaneous triptorelin in progesterone-primed ovarian stimulation cycles.

Key facts

Sponsor
Santiago Dexeus Font Fundacio Privada
Participant type
Patients
Age range
18-64 years
Gender
Female
Therapeutic area
Diseases [C] - Female Urogenital Diseases and Pregnancy Complications [C13]
Decision date (initial)
2024-12-09
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 compare the number of metaphase II oocytes retrieved following triggering of final oocyte maturation with intranasal nafarelin compared to subcutaneous triptorelin in progesterone-primed ovarian stimulation cycles.

Secondary objectives 7

  1. Total number of oocytes retrieved
  2. Ovarian Hyperstimulation Syndrome
  3. Other side effects/adverse effects
  4. Cost
  5. Serum LH and FSH levels 12 hours after trigger
  6. Serum LH, FSH and progesterone levels at the time of oocyte collection
  7. Participant reported pain, ease of use and medication preference

Conditions and MedDRA coding

Infertility

VersionLevelCodeTermSystem organ class
20.1 LLT 10016398 Female infertility 10038604

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 4

  1. Age 18- 40
  2. Women undergoing fertility preservation cycles with oocyte cryopreservation
  3. Undergoing a progesterone-primed ovarian stimulation cycle (PPOS) with any commercially available gonadotropin preparation(s)
  4. BMI 18 – 30 kg/m2

Exclusion criteria 5

  1. Allergy or hypersensitivity to either nafarelin or triptorelin
  2. Hypopituitarism
  3. Known pituitary tumour
  4. Contraindication to intranasal medication administration
  5. Previous poor response to agonist trigger

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

  1. The number of MII oocytes retrieved.

Secondary endpoints 7

  1. Total number of oocytes collected
  2. Ovarian Hyperstimulation Syndrome
  3. Other side effects/adverse effects
  4. Cost
  5. Serum LH and FSH levels 12 hours after trigger
  6. Serum LH, FSH and progesterone levels at the time of oocyte collection
  7. Participant reported pain, ease of use and medication preference

Investigational products

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

Test 1

Synarel 200 microgramos solución para pulverización nasal

PRD2546449 · Product

Active substance
Nafarelin
Pharmaceutical form
NASAL SPRAY, SOLUTION
Route of administration
NASAL SPRAY
Max daily dose
800 µg microgram(s)
Max total dose
800 µg microgram(s)
Max treatment duration
1 Day(s)
Authorisation status
Authorised
ATC code
H01CA02 — NAFARELIN
Marketing authorisation
60.079
MA holder
PFIZER, S.L.
MA country
Spain
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Comparator 1

Decapeptyl diario 0,1 mg polvo y disolvente para solución inyectable

PRD390680 · Product

Active substance
Triptorelin
Substance synonyms
TRIPTORELINE
Pharmaceutical form
SOLUTION FOR INJECTION
Route of administration
SUBCUTANEOUS INJECTION
Max daily dose
200 µg microgram(s)
Max total dose
200 µg microgram(s)
Max treatment duration
1 Day(s)
Authorisation status
Authorised
ATC code
L02AE04 — TRIPTORELIN
Marketing authorisation
62.431
MA holder
IPSEN PHARMA SA
MA country
Spain
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Santiago Dexeus Font Fundacio Privada

8 Total trials 5 Recruiting 2 Ended
Academic / Non-commercial
Sponsor organisation
Santiago Dexeus Font Fundacio Privada
Address
Gran Via De Carles III 71-75
City
Barcelona
Postcode
08028
Country
Spain

Scientific contact point

Organisation
Santiago Dexeus Font Fundacio Privada
Contact name
Ignacio Rodriguez

Public contact point

Organisation
Santiago Dexeus Font Fundacio Privada
Contact name
Ignacio Rodriguez

Locations

1 EU/EEA country · 5 investigational sites

By country

CountryMS statusPlanned subjectsSites
Spain Authorised, recruitment pending 154 5
Rest of world — 0 —

Investigational sites

Spain

5 sites · Authorised, recruitment pending
Dexeus Mujer Reus
Department of Reproductive Medicine, Pg de Prim, 2, Reus Tarragona
Hospital Universitari General De Catalunya
Department of Reproductive Medicine, Carrer Pedro I Pons 1, 08195, Sant Cugat Del Valles
Hospital Universitari Dexeus Grupo Quironsalud
Department of Reproductive Medicine, Calle De Sabino Arana 5-19, 08028, Barcelona
Hospital Quironsalud Del Valles
Department of Reproductive Medicine, Passeig Rubio I Ors 25-27, 08203, Sabadell
Dexeus Mujer Tarragona
Department of Reproductive Medicine, Av. Josep Maria Recasens, SN, Tarragona

Results and documents

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

Documents 27 files

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

TypeTitleVersion
Protocol (for publication) D1_Protocol_INFORM 1
Recruitment arrangements (for publication) Copies INFORM 1
Recruitment arrangements (for publication) DEXEUS_MUJER_CampDig-INFORM-CarruselCast-1 1
Recruitment arrangements (for publication) DEXEUS_MUJER_CampDig-INFORM-CarruselCast-2 1
Recruitment arrangements (for publication) DEXEUS_MUJER_CampDig-INFORM-CarruselCast-3 1
Recruitment arrangements (for publication) DEXEUS_MUJER_CampDig-INFORM-CarruselCat-1 1
Recruitment arrangements (for publication) DEXEUS_MUJER_CampDig-INFORM-CarruselCat-2 1
Recruitment arrangements (for publication) DEXEUS_MUJER_CampDig-INFORM-CarruselCat-3 1
Recruitment arrangements (for publication) DEXEUS_MUJER_CampDig-INFORM-StoryCast-1 1
Recruitment arrangements (for publication) DEXEUS_MUJER_CampDig-INFORM-StoryCast-2 1
Recruitment arrangements (for publication) DEXEUS_MUJER_CampDig-INFORM-StoryCat-1 1
Recruitment arrangements (for publication) DEXEUS_MUJER_CampDig-INFORM-StoryCat-2 1
Recruitment arrangements (for publication) K1_Recruitment arrangements 1
Recruitment arrangements (for publication) K1_Recruitment arrangements_INFORM_ModSus1 2
Recruitment arrangements (for publication) mailing INFORM_CAT 1
Recruitment arrangements (for publication) mailing INFORM_ES 1
Recruitment arrangements (for publication) reel 1
Recruitment arrangements (for publication) web INFORM CAT 1
Recruitment arrangements (for publication) web INFORM_ES 1
Subject information and informed consent form (for publication) L1_HIPCI_INFORM 3
Subject information and informed consent form (for publication) L1_HIPCI_INFORM_ES 2
Summary of Product Characteristics (SmPC) (for publication) FT_Decapeptyl 1
Summary of Product Characteristics (SmPC) (for publication) FT_Synarel 1
Synopsis of the protocol (for publication) D1_Summary INFORM_EN 1
Synopsis of the protocol (for publication) D1_Summary INFORM_ES 1
Synopsis of the protocol (for publication) SUMMARY INFORM ES 2
Synopsis of the protocol (for publication) SUMMARY INFORM_EN 2

Application history

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

#TypeCodeSubmittedReference MSConclusionDecision date
1 INITIAL IN 2024-09-13 Spain Acceptable
2024-12-09
 2024-12-09
2 SUBSTANTIAL MODIFICATION SM-1 2026-04-10 Spain Acceptable
2026-05-25
 2026-06-01

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