Overview
Sponsor-declared trial summary
Phase
Therapeutic use (Phase IV)
Status
Ongoing, recruiting
Participants planned
150
Countries
1
Sites
3
Women undergoing ovarian stimulation for oocyte donation.
To compare the efficacy (non-inferiority) of the Utrogestan protocol compared to an antagonist protocol.
Key facts
- Sponsor
- Instituto Bernabeu S.L.
- Participant type
- Healthy volunteers
- Age range
- 18-64 years
- Gender
- Female
- Therapeutic area
- Diseases [C] - Female Urogenital Diseases and Pregnancy Complications [C13]
- Trial duration
- 8 Nov 2023 → ongoing
- Decision date (initial)
- 2023-05-09
- Transition trial
- No
- Low-intervention
- Yes
- Rare-disease indication
- No
- Vulnerable population
- No
- Funding sources
- Instituto Bernabeu
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Efficacy
To compare the efficacy (non-inferiority) of the Utrogestan protocol compared to an antagonist protocol.
Secondary objectives 10
- To compare the duration of treatment of both protocols (oral progesterone vs. injectable antagonist).
- To check if there are differences in the baseline characteristics of the two groups.
- To analyze the total cost of each treatment.
- To compare the economic cost per number of mature oocyte (MII) obtained between both groups.
- To investigate whether there are differences in terms of the yield of fresh MII and their potential to reach blastocyst after ICSI.
- To collect and analyze the information about the fresh embryo transfers.
- To collect and compare the information about the type of endometrial preparation of each fresh transfer and the characteristics of the embryo transfer.
- To evaluate the gestation rate of the blastocysts obtained in the study.
- To collect information on on-going pregnancies, miscarriages and deliveries during the 9 months following each embryo transfer.
- To analyze possible differences in obstetric terms between the two protocols.
Conditions and MedDRA coding
Women undergoing ovarian stimulation for oocyte donation.
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 8
- Be eligible to enter the Instituto Bernabeu's oocyte donation program.
- Age between 18 and 33 years
- BMI >18 and <30
- Antral follicle count >8 (adding both ovaries).
- Presence of both ovaries
- Ability to participate and comply with the study protocol.
- Understand Spanish orally and in writing.
- Have given written consent
Exclusion criteria 8
- Diagnosis of endometriosis at any stage.
- Diagnosis of any ovarian tumor whether benign or malignant
- Concurrent participation in another study
- Malabsorptive syndromes that may alter the efficacy of Utrogestan ® such as bariatric surgery, ulcerative colitis or Crohn's disease.
- Irregular periods.
- Hypogonadotropic hypogonadism.
- Having received in the previous two months treatment with ovulation stimulators.
- Having previously participated in the present study.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Number of oocytes obtained at metaphase II (MII) stage.
Secondary endpoints 4
- Number of cumulus-oocyte complexes (CCO) obtained.
- Number of germinal vesicles (VG).
- Number of metaphase I (MI).
- Number of oocytes suitable for insemination or microinjection.
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
Seidigestan 200 mg cápsulas blandas
PRD308331 · Product
- Active substance
- Progesterone
- Pharmaceutical form
- CAPSULE, SOFT
- Route of administration
- ORAL
- Max daily dose
- 200 mg milligram(s)
- Max total dose
- 2800 mg milligram(s)
- Max treatment duration
- 14 Day(s)
- Authorisation status
- Authorised
- ATC code
- G03DA04 — PROGESTERONE
- Marketing authorisation
- 64.899
- MA holder
- SEID, S.A.
- MA country
- Spain
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Comparator 1
Astarté 0,25 mg/0,5 ml solución inyectable en jeringa precargada EFG
PRD9301930 · Product
- Active substance
- Ganirelix
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SUBCUTANEOUS
- Max daily dose
- 0.25 mg/ml milligram(s)/millilitre
- Max total dose
- 2.5 mg/ml milligram(s)/millilitre
- Max treatment duration
- 10 Day(s)
- Authorisation status
- Authorised
- ATC code
- H01CC01 — GANIRELIX
- Marketing authorisation
- 86368
- MA holder
- GP-PHARM S.A.
- MA country
- Spain
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Auxiliary 4
Ovaleap 300 IU/0.5 mL solution for injection
PRD6962008 · Product
- Active substance
- Follitropin Alfa (Genetical Recombination)
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SUBCUTANEOUS
- Max daily dose
- 300 IU international unit(s)
- Max total dose
- 4200 IU international unit(s)
- Max treatment duration
- 14 Day(s)
- Authorisation status
- Authorised
- ATC code
- G03GA05 — FOLLITROPIN ALFA
- Marketing authorisation
- EU/1/13/871/001
- MA holder
- THERAMEX IRELAND LIMITED
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Bemfola 225 IU/0.375 mL solution for injection in pre-filled pen
PRD4646898 · Product
- Active substance
- Follitropin Alfa
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SUBCUTANEOUS
- Max daily dose
- 225 IU international unit(s)
- Max total dose
- 3150 IU international unit(s)
- Max treatment duration
- 14 Day(s)
- Authorisation status
- Authorised
- ATC code
- G03GA05 — FOLLITROPIN ALFA
- Marketing authorisation
- EU/1/13/909/011
- MA holder
- GEDEON RICHTER PLC.
- MA country
- Liechtenstein
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Bemfola 150 IU/0.25 mL solution for injection in pre-filled pen
PRD4646811 · Product
- Active substance
- Follitropin Alfa
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SUBCUTANEOUS
- Max daily dose
- 150 IU international unit(s)
- Max total dose
- 2100 IU international unit(s)
- Max treatment duration
- 14 Day(s)
- Authorisation status
- Authorised
- ATC code
- G03GA05 — FOLLITROPIN ALFA
- Marketing authorisation
- EU/1/13/909/009
- MA holder
- GEDEON RICHTER PLC.
- MA country
- Norway
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Decapeptyl diario 0,1 mg polvo y disolvente para solución inyectable
PRD390680 · Product
- Active substance
- Triptorelin
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SUBCUTANEOUS
- Max daily dose
- 0.4 mg milligram(s)
- Max total dose
- 0.4 mg milligram(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
Instituto Bernabeu S.L.
- Sponsor organisation
- Instituto Bernabeu S.L.
- Address
- Avinguda Albufereta 31
- City
- Alicante
- Postcode
- 03016
- Country
- Spain
Scientific contact point
- Organisation
- Instituto Bernabeu S.L.
- Contact name
- María Martínez Moya (Principal Investigator)
Public contact point
- Organisation
- Instituto Bernabeu S.L.
- Contact name
- Anna Pitas (Study Coordinator)
Locations
1 EU/EEA country · 3 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Spain | Ongoing, recruiting | 150 | 3 |
| 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 | 2023-11-08 | 2023-11-16 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-02-28 | Spain | Acceptable 2023-05-09
|
2023-05-09 |