Overview
Sponsor-declared trial summary
Subfertility
Finding the optimal endometrial preparation protocol for transfer of a frozen-thawed embryo
Key facts
- Sponsor
- UZ Leuven
- Participant type
- Patients
- Age range
- 18-64 years
- Gender
- Female
- Therapeutic area
- Diseases [C] - Female Urogenital Diseases and Pregnancy Complications [C13]
- Trial duration
- 26 Jun 2018 → ongoing
- Decision date (initial)
- 2025-01-22
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2024-511890-30-03
- EudraCT number
- 2018-001014-15
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Efficacy
Finding the optimal endometrial preparation protocol for transfer of a frozen-thawed embryo
Conditions and MedDRA coding
Subfertility
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 6
- • Women undergoing FET after a first, second or third fresh IVF/ICSI cycle
- • Single embryo transfer (SET) or Double embryo transfer (DET)
- • Female age between 18-45 year
- • Women having a natural ovulatory cycle (24-35 days)
- • Normal uterine cavity (fundal indentation at the cavity <10mm)
- • Written informed consent
Exclusion criteria 3
- • Use of donor gametes
- • BMI > or equal to 35 kg / m2
- • Any contra-indication to estrogen or progesterone supplementation (e.g. history of thrombosis, prior or current hormone-sensitive malignancy…)
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Clinical pregnancy rate with fetal heart beat
Secondary endpoints 2
- Biochemical pregnancy rate, miscarriage rate, ectopic pregnancy rate, live birth rate, multiple pregnancy rate, adverse events, cycle cancellation rate, endometrial thickness, endometrial pattern, number of center visits to monitor FET cycle, cost analysis per cycle, patient satisfaction
- Obstetrical outcomes in case of pregnancy: gestational age, birth weight, incidence of pregnancy- induced hypertension, pre-eclampsia, placenta previa, placenta accrete/increta/percreta, abruptio placentae, postpartum hemorrhage (early, late)
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 2
Progynova 2 mg dragerade tabletter
PRD1776032 · Product
- Active substance
- Estradiol Valerate
- Pharmaceutical form
- COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 8 mg milligram(s)
- Max total dose
- 672 mg milligram(s)
- Max treatment duration
- 12 Week(s)
- Authorisation status
- Authorised
- ATC code
- G03CA03 — ESTRADIOL
- Marketing authorisation
- 4881
- MA holder
- BAYER OY
- MA country
- Finland
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Utrogestan 200 mg capsule molli vaginali
PRD10224843 · Product
- Active substance
- Progesterone, Micronised
- Pharmaceutical form
- VAGINAL CAPSULE, SOFT
- Route of administration
- VAGINAL USE
- Max daily dose
- 600 mg milligram(s)
- Max total dose
- 50.4 g gram(s)
- Max treatment duration
- 12 Week(s)
- Authorisation status
- Authorised
- ATC code
- G03DA04 — PROGESTERONE
- Marketing authorisation
- 050211010
- MA holder
- BESINS HEALTHCARE IRELAND LIMITED
- MA country
- Italy
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
UZ Leuven
- Sponsor organisation
- UZ Leuven
- Address
- Herestraat 49
- City
- Leuven
- Postcode
- 3000
- Country
- Belgium
Scientific contact point
- Organisation
- UZ Leuven
- Contact name
- Joke De Roover
Public contact point
- Organisation
- UZ Leuven
- Contact name
- Joke De Roover
Locations
1 EU/EEA country · 5 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Belgium | Ongoing, recruitment ended | 554 | 5 |
| 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 |
|---|---|---|---|---|---|
| Belgium | 2018-06-26 | 2018-10-15 | 2024-11-12 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 8 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol 2024-511890-30 | 6 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements | 1 |
| Subject information and informed consent form (for publication) | L1_ICF DUT | 7 |
| Subject information and informed consent form (for publication) | L1_ICF EN | 7 |
| Subject information and informed consent form (for publication) | L1_ICF FR | 7 |
| Summary of Product Characteristics (SmPC) (for publication) | G2_SmPC Progynova | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | G2_SmPC Utrogestan | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_2024-511890-30 | 1 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-01-17 | Belgium | Acceptable 2025-01-20
|
2025-01-22 |