Overview
Sponsor-declared trial summary
Phase
Therapeutic confirmatory (Phase III)
Status
Ongoing, recruiting
Participants planned
1,020
Countries
1
Sites
5
infertility
To compare the ongoing pregnancy rate following luteal phase support with standard formulation (200mg tid) and a new formulation (400mg bid) vaginal micronized progesterone in patients undergoing an AC-FET.
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
- 5 Jul 2023 → ongoing
- Decision date (initial)
- 2024-04-23
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
- Funding sources
- Besins
External identifiers
- EU CT number
- 2024-513102-57-00
- EudraCT number
- 2022-001045-21
- ClinicalTrials.gov
- NCT05899010
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Efficacy, Safety, Others
To compare the ongoing pregnancy rate following luteal phase support with standard formulation (200mg tid) and a new formulation (400mg bid) vaginal micronized progesterone in patients undergoing an AC-FET.
Secondary objectives 3
- To compare the standard and the new formulations regarding: Prevalence of serum progesterone (P) levels <10 ng/ml before FET, implantation rate, biochemical pregnancy rate (defined as a pregnancy diagnosed only by the detection of bHCG in serum or urine), clinical pregnancy rate (defined as the presence of at least one embryo with heartbeat on transvaginal ultrasound), Miscarriage rate, Frequency of adverse events
- To compare the following endpoints in patients with serum P <10ng/ml on the day before ET versus patients with P≥10ng/ml: Implantation rate, Biochemical pregnancy rate, Clinical pregnancy rate, Ongoing pregnancy rate, Miscarriage rate, Incidence of adverse events with oral micronized progesterone
- Post study information: Live birth rate, Pregnancy complications, Preeclampsia, Preterm birth, Fetal growth restriction
Conditions and MedDRA coding
infertility
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 8
- patients undergoing an artificial cycle-frozen embryo transfer (AC-FET)
- Endometrial preparation with hormone replacement therapy
- Age 18-43 years following an autologous IVF cycle (with or without preimplantation genetic testing for aneuploidy)
- Age < 50 years following an egg donation cycle
- BMI > 18 and < 30 kg/m2
- blastocyst embryo transfer
- Willing to participate in the study
- Able to come to the Center to comply with the procedures of the study: blood tests, appointments and drug dispensation.
Exclusion criteria 9
- Uterine diseases (e.g. submucosal fibroids, polyps, previously diagnosed Müllerian abnormalities)
- Hydrosalpinx
- Recurrent pregnancy loss (≥ 3 previous miscarriages)
- Recurrent implantation failure (≥ 3 previously failed embryo transfers of good-quality blastocysts)
- Allergy to study medication
- pregnancy or lactation
- Contraindication for hormonal treatment
- Personalized initiation of exogenous progesterone according to a previous endometrial receptivity assay test
- Recent history of severe disease requiring regular treatment (clinically significant concurrent medical condition that could compromise subject safety or interfere with the trial assessment).
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- The primary efficacy endpoint is the comparison of ongoing pregnancy rate. The primary efficacy endpoint is related to the primary trial objective.
Secondary endpoints 5
- Implantation rate
- Biochemical pregnancy rate
- Clinical pregnancy rate
- Miscarriage rate
- Frequency of adverse events
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 3
Lugesteron 400 mg pehmeät emätinpuikot, kapselit
PRD11163528 · Product
- Active substance
- Progesterone
- Pharmaceutical form
- VAGINAL CAPSULE, SOFT
- Route of administration
- VAGINAL USE
- Max daily dose
- 800 mg milligram(s)
- Max total dose
- 400 mg milligram(s)
- Max treatment duration
- 60 Week(s)
- Authorisation status
- Authorised
- ATC code
- G03DA04 — PROGESTERONE
- Marketing authorisation
- 41494
- MA holder
- BESINS HEALTHCARE IRELAND LIMITED
- MA country
- Finland
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB45084 · Substance
- Active substance
- Progesterone, Micronised
- Pharmaceutical form
- VAGINAL CAPSULE, SOFT
- Route of administration
- VAGINAL USE
- Max daily dose
- 600 mg milligram(s)
- Max total dose
- 200 mg milligram(s)
- Max treatment duration
- 60 Day(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB45084 · Substance
- Active substance
- Progesterone, Micronised
- Pharmaceutical form
- VAGINAL CAPSULE, SOFT
- Route of administration
- ORAL
- Max daily dose
- 300 mg milligram(s)
- Max total dose
- 300 mg milligram(s)
- Max treatment duration
- 52 Day(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Comparator 1
Estradiol Besins 0,75 mg/dose, gel transdermique
PRD8969197 · Product
- Active substance
- Estradiol Hemihydrate
- Pharmaceutical form
- TRANSDERMAL GEL
- Route of administration
- TRANSDERMAL USE
- Max daily dose
- 6 mg milligram(s)
- Max total dose
- 3 mg milligram(s)
- Max treatment duration
- 10 Week(s)
- Authorisation status
- Authorised
- ATC code
- G03CA03 — ESTRADIOL
- Marketing authorisation
- BE585262
- MA holder
- BESINS HEALTHCARE 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 Soporte Investigación
Public contact point
- Organisation
- Santiago Dexeus Font Fundacio Privada
- Contact name
- Unidad Soporte Investigación
Locations
1 EU/EEA country · 5 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Spain | Ongoing, recruiting | 1,020 | 5 |
| Rest of world | — | 0 | — |
Investigational sites
Hospital Universitari Dexeus Grupo Quironsalud
Department of Reproductive Medicine, Calle De Sabino Arana 5-19, 08028, Barcelona
Hospital Universitari General De Catalunya
Department of Reproductive Medicine, Carrer Pedro I Pons 1, 08195, Sant Cugat Del Valles
Hospital Quironsalud Del Valles
Departmen of Reproductive Medicine, Passeig Rubio I Ors 25-27, 08203, Sabadell
Dexeus Mujer Reus
Department of Reproductive Medicine, Pg de Prim, 2, Reus Tarragona
Dexeus Mujer Tarragona
Department of Reproductive Medicine, Av. Josep Maria Recasens, SN, Tarragona
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 | 2023-07-05 | 2023-07-18 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 15 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_ MIPROF Protocol 19122022 | 1 |
| Protocol (for publication) | D1_Protocol MI-PROF | 2 |
| Protocol (for publication) | D1_Protocol_MI-PROF_TC | 2 |
| Recruitment arrangements (for publication) | K1_recruitment arrangements | 1 |
| Subject information and informed consent form (for publication) | L1_HIPCI MI-PROF_ESP V1 15092022 | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | 5- Estrogel DCP English common-spc-cl_Approved 02082022 | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | 5-estrogel BE smpcFR | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | 5-Estrogel-Consumer-Medicine-Information | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | 5-ficha tecnica Utro100_200 FT_64899 | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | FIMEA Myyntilupa_Lugesteron_400_mg_ematinpuikko_kapseli_pehmea_472330_paatos_Redacted | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | Lugesterone fi-spc-400mg_24032020 Finnish | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | MiProf Utro 300 letter 11052022CPP | 1 |
| Synopsis of the protocol (for publication) | D1_RESUMEN MIPROF AEMPS | 1 |
| Synopsis of the protocol (for publication) | D1_Summary MI-PROF_EN | 2 |
| Synopsis of the protocol (for publication) | D1_Summary MI-PROF_EN_TC | 2 |
Application history
3 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-04-08 | Spain | Acceptable 2024-04-23
|
2024-04-23 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-09-03 | Spain | 2024-10-21 | |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-09-25 | Spain | Acceptable 2025-11-05
|
2025-11-07 |