Overview
Sponsor-declared trial summary
Phase
Therapeutic use (Phase IV)
Status
Ongoing, recruiting
Participants planned
120
Countries
1
Sites
4
infertility
The aim of the study is to compare serum progesterone levels as well as P4/E2 ratio on the day of ovulation triggering following treatment with 300 IU of rhFSH and 150 IU of rhLH (Pergoveris®) versus 300 IU of rhFSH alone (Gonal-F®) in a GnRH antagonist protocol, in women with low ovarian sensitivity belonging to POSEI…
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]
- Trial duration
- 23 Sep 2024 → ongoing
- Decision date (initial)
- 2024-09-23
- Transition trial
- Yes
- Low-intervention
- Yes
- Rare-disease indication
- No
- Vulnerable population
- No
- Funding sources
- Merck SLU · Fundación Santiago Dexeus Font
External identifiers
- EU CT number
- 2024-514035-19-00
- EudraCT number
- 2020-003302-30
- ClinicalTrials.gov
- NCT04719000
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Efficacy
The aim of the study is to compare serum progesterone levels as well as P4/E2 ratio on the day of ovulation triggering following treatment with 300 IU of rhFSH and 150 IU of rhLH (Pergoveris®) versus 300 IU of rhFSH alone (Gonal-F®) in a GnRH antagonist protocol, in women with low ovarian sensitivity belonging to POSEIDON group 2, who demonstrated a previous suboptimal response with a starting dose of ≤225 IU with any gonadotropin in a previous cycle with a GnRH antagonist protocol.
Secondary objectives 1
- To evaluate how gonadotropins could influence the whole endocrinological profile and ART clinical outcomes of patients with low ovarian sensitivity, belonging to POSEIDON category group 2 who undergo a new ovarian stimulation with a dose of rhFSH 300 IU (Gonal-F®) or 300 IU rhFSH plus 150 IU rhLH (Pergoveris®) in a GnRH antagonist protocol.
Conditions and MedDRA coding
infertility
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.1 | LLT | 10016398 | Female infertility | 10038604 |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 7
- POSEIDON group 2 patients
- Able and willing to sign the Patient Consent Form and adhere to study visitation schedule.
- Age: ≥ 35 years ≤40 years old.
- antral Follicle Count (AFC) ≥5 and /or antimullerian hormone (AMH) ≥1.2 ng/mL.
- <4 or 4-9 oocytes retrieved in a previous IVF/ICSI cycle with a starting dose of ≤225IU with any gonadotropin under a GnRH antagonist protocol.
- Up to 3 previous ovarian stimulation cycles with a starting dose of ≤225IU in which dose adjustments during stimulation did not exceed 300IU.
- Ovarian stimulation for IVF/ICSI
Exclusion criteria 13
- Poor ovarian responders according to the Bologna criteria.
- PCOS patients according to the Rotterdam criteria.
- AFC>20.
- Age >40 or <35 years old.
- Women with >10 oocytes retrieved in a previous IVF/ICSI cycle with 150-225 IU starting dose.
- Women who required dose adjustments during stimulation >300 IU with any gonadotropin in their previous cycle
- Uterine abnormalities.
- Recent history of any current untreated endocrine abnormality.
- Unilateral or bilateral hydrosalpinx (visible on USS, unless clipped).
- Contraindications for the use of medicine used for ovarian stimulation (gonadotropins, GnRH antagonist, progesterone vaginal gel)
- Recent history of severe disease requiring regular treatment (Clinically significant concurrent medical condition that could compromise subject safety or interfered with the trial assessment and patients with any contraindication to pregnancy).
- PGT-a (Preimplantation Genetic Testing for Aneuploidies).
- TESA or TESE (Testicular Sperm Aspiration or Testicular Sperm Extraction)
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- The primary efficacy endpoint is serum progesterone levels as well as P4/E2 ratio on the day of ovulation triggering. The primary efficacy endpoint is related to the primary trial objective.
Secondary endpoints 9
- Serum levels of estradiol, FSH, Testosterone and LH levels and P4/E2 ratio on days 1, 6, 8, 10 and the final day of oocyte maturation.
- Progesterone-to-follicle Index (PFI) on the day of ovulation triggering
- Number of oocytes.
- Number of patients with optimal number of oocytes retrieved (≥10 oocytes).
- Number of embryos.
- Good-quality embryos.
- Number of blastocysts.
- Clinical pregnancy defined as the presence of intrauterine gestational sac at 6-7 weeks of gestation.
- Ongoing pregnancy defined as the presence of intrauterine gestational sac with an embryonic pole demonstrating cardiac activity at 8-9 weeks of gestation.
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
GONAL-f 900 IU/1.44 mL solution for injection in pre-filled pen
PRD3526872 · Product
- Active substance
- Follitropin Alfa
- Pharmaceutical form
- SOLUTION FOR INJECTION IN PRE-FILLED PEN
- Route of administration
- SUBCUTANEOUS USE
- Max daily dose
- 300 IU international unit(s)
- Max total dose
- 4500 IU international unit(s)
- Max treatment duration
- 15 Day(s)
- Authorisation status
- Authorised
- ATC code
- G03GA05 — FOLLITROPIN ALFA
- Marketing authorisation
- EU/1/95/001/035
- MA holder
- MERCK EUROPE B.V.
- MA country
- Liechtenstein
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Comparator 1
Pergoveris (900 IU + 450 IU)/1.44 mL solution for injection in pre-filled pen
PRD5041898 · Product
- Active substance
- Follitropin Alfa
- Pharmaceutical form
- SOLUTION FOR INJECTION IN PRE-FILLED PEN
- Route of administration
- SUBCUTANEOUS USE
- Max daily dose
- 300 IU international unit(s)
- Max total dose
- 4500 IU international unit(s)
- Max treatment duration
- 15 Day(s)
- Authorisation status
- Authorised
- ATC code
- G03GA30 — -
- Marketing authorisation
- EU/1/07/396/006
- MA holder
- MERCK EUROPE B.V.
- MA country
- Norway
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Auxiliary 3
Cetrotide 0.25 mg powder and solvent for solution for injection
PRD3311120 · Product
- Active substance
- Cetrorelix
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SUBCUTANEOUS USE
- Max daily dose
- 0.25 mg milligram(s)
- Max total dose
- 2.25 mg milligram(s)
- Max treatment duration
- 9 Day(s)
- Authorisation status
- Authorised
- ATC code
- H01CC02 — CETRORELIX
- Marketing authorisation
- EU/1/99/100/001
- MA holder
- MERCK EUROPE B.V.
- MA country
- Iceland
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Ovitrelle 250 micrograms solution for injection in pre-filled pen
PRD3312175 · Product
- Active substance
- Choriogonadotropin Alfa
- Pharmaceutical form
- SOLUTION FOR INJECTION IN PRE-FILLED PEN
- Route of administration
- SUBCUTANEOUS USE
- Max daily dose
- 6500 IU international unit(s)
- Max total dose
- 6500 IU international unit(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- G03GA08 — CHORIOGONADOTROPIN ALFA
- Marketing authorisation
- EU/1/00/165/008
- MA holder
- MERCK EUROPE B.V.
- MA country
- Iceland
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
PRD2159595 · Product
- Active substance
- Progesterone
- Pharmaceutical form
- VAGINAL GEL
- Route of administration
- VAGINAL USE
- Max daily dose
- 90 mg milligram(s)
- Max total dose
- 3780 mg milligram(s)
- Max treatment duration
- 6 Week(s)
- Authorisation status
- Authorised
- ATC code
- G03DA04 — PROGESTERONE
- Marketing authorisation
- BE184895
- MA holder
- MERCK N.V./S.A.
- MA country
- Belgium
- 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
- 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
- Unidad de Apoyo a la Investigación
Public contact point
- Organisation
- Santiago Dexeus Font Fundacio Privada
- Contact name
- Unidad de Apoyo a la Investigación
Locations
1 EU/EEA country · 4 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Spain | Ongoing, recruiting | 120 | 4 |
| Rest of world | — | 0 | — |
Investigational sites
Hospital Universitari Dexeus Grupo Quironsalud
Department of Reproductive Medicine, Calle De Sabino Arana 5-19, 08028, Barcelona
Hospital Universitario 12 De Octubre
Unidad de Reproducción Humana, Bloque D, Avenida De Cordoba Sn, Madrid
Hospital Clinic De Barcelona
institut Clínic de Ginecologia, obstetricia i neonatologia (ICGON), Calle Villarroel 170, 08036, Barcelona
Hospital Universitario Quironsalud Madrid
Unidad de Reproducción Asistida Servicio de Obstetricia y Ginecologia, Calle De Diego De Velazquez 1, 28223, Pozuelo De Alarcon
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 | 2024-09-23 | 2024-09-23 |
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.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocolo_1_2020_07_15 | 1 |
| Recruitment arrangements (for publication) | K1_recruitment arrangements | 1 |
| Subject information and informed consent form (for publication) | L1_HIPCI PEARL EN V3 17112021 blank CEIm limpia | 1 |
| Subject information and informed consent form (for publication) | L1_HIPCI PEARL ESP V3 17112021 blank CEIm limpio | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | G2_GONAL-900-FT | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | G2_PERGOVERIS-900-FT | 1 |
| Synopsis of the protocol (for publication) | D1_summary RESUMEN PEARL V1_150720 _OCTUBRE | 1 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-09-13 | Spain | Acceptable with conditions 2024-09-23
|
2024-09-23 |