Overview
Sponsor-declared trial summary
Phase
Therapeutic use (Phase IV)
Status
Ongoing, recruitment ended
Participants planned
1,800
Countries
2
Sites
11
Infertility
The primary objective is to investigate if luteal phase support by vaginal progesterone, is superior to no luteal phase support, in terms of live birth per woman undergoing FET-NC, and if superiority is shown, if 7 weeks of progesterone treatment is superior to 3 weeks treatment.
Key facts
- Sponsor
- Vaestra Goetalandsregionen
- Participant type
- Patients
- Age range
- 18-64 years
- Gender
- Female
- Therapeutic area
- Diseases [C] - Female Urogenital Diseases and Pregnancy Complications [C13]
- Trial duration
- 20 Apr 2021 → ongoing
- Decision date (initial)
- 2024-07-15
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2024-512844-40-00
- EudraCT number
- 2020-005552-38
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Therapy
The primary objective is to investigate if luteal phase support by vaginal progesterone, is superior to no luteal phase support, in terms of live birth per woman undergoing FET-NC, and if superiority is shown, if 7 weeks of progesterone treatment is superior to 3 weeks treatment.
Secondary objectives 5
- To compare treatment groups regarding pregnancy outcomes including biochemical, clinical, ongoing and term pregnancy rates, as well as rates of miscarriage, termination of pregnancy and ectopic pregnancy.
- To compare treatment groups regarding perinatal and obstetric outcomes.
- To compare treatment groups regarding self-reported side effects and adverse events.
- To compare treatment groups regarding cost effectiveness.
- To analyze the effect of S-progesterone level before FET on the chance of achieving live birth and secondary pregnancy outcomes.
Conditions and MedDRA coding
Infertility
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 6
- Planned for a FET-NC with a blastocyst
- Age≥18<43 years
- BMI≥18.5<35
- Regular menstrual cycles 24-35 days
- Given informed consent
- Understand written and spoken Swedish, English or Arabic
Exclusion criteria 4
- ART-related: Oocyte donor cycles. Preimplantation Genetic Testing (PGT) cycles. Uterine malformation, precluding cervical access to the uterine cavity. Submucous myoma and endometrial polyps requiring surgery before transfer of embryo.
- Drug-related: Hypersensitivity against study medication. Other contraindications according to FASS: Undiagnosed vaginal bleeding, severely impaired liver function or liver disease, known or suspected malignancy of breast or genital region, ongoing arterial or venous thromboembolism, porphyria or history of these conditions (FASS.se).
- Development of serious disease contraindicating ART or pregnancy.
- Participation or recent participation in a clinical study with an investigational product (during the past 30 days). Previous participation in this study.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Live birth
Secondary endpoints 5
- Biochemical pregnancy, clinical pregnancy, ongoing pregnancy, term pregnancy, miscarriage, ectopic pregnancy, termination of pregnancy, intrauterine fetal death, perinatal death.
- Perinatal outcomes: birth weight, gestational age, preterm birth (PTB), very PTB, low birth weight (LBW), very LBW, stillbirth, perinatal death (stillbirth + early neonatal death = neonatal death <7 days), birth defects detected at birth.
- Obstetric outcomes: hypertensive disorders of pregnancy (gestational hypertension and pre-eclampsia) (HDP), placenta previa, placenta abruption, postpartum hemorrhage (PPH).
- Cost-effectiveness
- Progesterone levels in blood samples from day LH+3
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 2
Lutinus 100 mg vaginaltabletter
PRD475933 · Product
- Active substance
- Progesterone
- Pharmaceutical form
- VAGINAL TABLET
- Route of administration
- VAGINAL USE
- Max daily dose
- 300 mg milligram(s)
- Max total dose
- 14700 mg milligram(s)
- Max treatment duration
- 7 Week(s)
- Authorisation status
- Authorised
- ATC code
- G03DA04 — PROGESTERONE
- Marketing authorisation
- 26884
- MA holder
- FERRING LÄKEMEDEL AB
- MA country
- Sweden
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
PRD7275307 · Product
- Active substance
- Progesterone
- Pharmaceutical form
- PESSARY
- Route of administration
- VAGINAL USE
- Max daily dose
- 800 mg milligram(s)
- Max total dose
- 39200 mg milligram(s)
- Max treatment duration
- 7 Week(s)
- Authorisation status
- Authorised
- ATC code
- G03DA04 — PROGESTERONE
- Marketing authorisation
- 54305
- MA holder
- GEDEON RICHTER PLC.
- MA country
- Sweden
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Vaestra Goetalandsregionen
- Sponsor organisation
- Vaestra Goetalandsregionen
- Address
- Regionens Hus
- City
- Vänersborg
- Postcode
- 462 80
- Country
- Sweden
Scientific contact point
- Organisation
- Vaestra Goetalandsregionen
- Contact name
- Christina Bergh
Public contact point
- Organisation
- Vaestra Goetalandsregionen
- Contact name
- Christina Bergh
Locations
2 EU/EEA countries · 11 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Iceland | Ongoing, recruitment ended | 100 | 1 |
| Sweden | Ongoing, recruitment ended | 1,700 | 10 |
| Rest of world | — | 0 | — |
Investigational sites
Sahlgrenska University Hospital-Vaestra Goetalandsregionen
Dept of Gynecology and Reproductive Medicine, Blå Stråket 6, 41345 Gothenburg, Bla Straket 5, 413 46, Goteborg
Livio Umeå
Livio Fertilitetscentrum Umeå, Kunskapens Hus Lasarettsbacken 7, Sweden, Umeå
Nordic IVF Sverige AB
Nordic IVF Sverige AB, Hammarby allé 93, 12063, Stockholm
IVF-gruppen vid Sophiahemmet AB
IVF-gruppen vid Sophiahemmet, Vallhallavägen 91 A, 11486, Stockholm
Region Oestergoetland
Universitetssjukhuset i Linköping, Avd. Obstetrik och Gynekologi, 58185 Linköping, Universitetssjukhuset I Linkoping, 581 85, Linkoping
Region Skane Skanes Universitetssjukhus
Reproduktionsmedicinskt centrum (RMC), Jan Waldenströms gata 47, 205 02 Malmö, St. Johns, Fritz Bauers Gata 5, Malmo
Region Oerebro Laen
Universitetssjukhuset Örebro, Fertilitetsenheten, Kvinnokliniken, 701 85 Örebro, Sodra Grev Rosengatan, 701 85, Orebro
Karolinska University Hospital
Section of Reproductive Medicine, Novumhuset, 141 86 Stockholm, Halsovagen, Flemingsberg, Huddinge
Livio Falun AB
Livio Falun, Åsgatan 30, 791 71, Falun
Livio Fertilitetscentrum AB Göteborg
Livio Fertilitetscentrum AB Göteborg, Carlandersparken 24, 40229, Göteborg
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 |
|---|---|---|---|---|---|
| Iceland | 2023-05-11 | 2023-05-17 | 2026-04-21 | ||
| Sweden | 2021-04-20 | 2021-04-21 | 2026-04-21 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-06-11 | Sweden | Acceptable 2024-06-26
|
2024-06-26 |