Clinical trial • Phase IV • Other
Progesterone for Infertility
Phase IV trial of Progesterone for Infertility.
Overview
- Trial Therapeutic Area
- Other
- Trial Disease
- Infertility
- Trial Stage
- Phase IV
- Drug Modality
- Small molecule
Key dates
- Initial CTIS Submission Date
- 11-06-2024
- First CTIS Authorization Date
- 26-06-2024
Trial design
Randomised, open-label, comparator arms: vaginal progesterone luteal support (products used in trial include cyclogest 400 mg pessary and lutinus 100 mg vaginal tablets) versus no luteal phase support. treatment duration comparisons include 3 weeks versus 7 weeks of progesterone if superiority is shown. specific per-dose schedule/frequency not detailed in part i data.-controlled Phase IV trial in Iceland, Sweden.
- Randomised
- Yes
- Open Label
- Yes
- Comparator
- Comparator arms: Vaginal progesterone luteal support (products used in trial include Cyclogest 400 mg pessary and Lutinus 100 mg vaginal tablets) versus no luteal phase support. Treatment duration comparisons include 3 weeks versus 7 weeks of progesterone if superiority is shown. Specific per-dose schedule/frequency not detailed in Part I data.
- Target Sample Size
- 1800
Eligibility
Recruits 1800 Vulnerable population selected (isVulnerablePopulationSelected = true). Participants must give informed consent. Inclusion requires understanding written and spoken Swedish, English or Arabic. No information provided on assent or guardian consent procedures; all participants are adults (Age≥18)..
- Pregnancy Exclusion
- Development of serious disease contraindicating ART or pregnancy.
- Vulnerable Population
- Vulnerable population selected (isVulnerablePopulationSelected = true). Participants must give informed consent. Inclusion requires understanding written and spoken Swedish, English or Arabic. No information provided on assent or guardian consent procedures; all participants are adults (Age≥18).
Inclusion criteria
- {"criterion_text":"- Planned for a FET-NC with a blastocyst\n- Age≥18<43 years\n- BMI≥18.5<35\n- Regular menstrual cycles 24-35 days\n- Given informed consent\n- Understand written and spoken Swedish, English or Arabic"}
Exclusion criteria
- {"criterion_text":"- 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.\n- 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).\n- Development of serious disease contraindicating ART or pregnancy.\n- Participation or recent participation in a clinical study with an investigational product (during the past 30 days). Previous participation in this study."}
Endpoints
Primary endpoints
- {"endpoint_text":"- Live birth","definition_or_measurement_approach":"Primary objective defined as live birth per woman undergoing FET-NC (investigate if luteal phase support by vaginal progesterone is superior to no luteal phase support)."}
Secondary endpoints
- {"endpoint_text":"- Biochemical pregnancy, clinical pregnancy, ongoing pregnancy, term pregnancy, miscarriage, ectopic pregnancy, termination of pregnancy, intrauterine fetal death, perinatal death.","definition_or_measurement_approach":"Pregnancy outcomes measured as biochemical, clinical, ongoing and term pregnancy rates; rates of miscarriage, termination of pregnancy, ectopic pregnancy, intrauterine fetal death, perinatal death as listed."}
- {"endpoint_text":"- 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.","definition_or_measurement_approach":"Perinatal outcomes measured by standard neonatal metrics: birth weight, gestational age, PTB/very PTB, LBW/very LBW, stillbirth, perinatal death, and birth defects detected at birth."}
- {"endpoint_text":"- Obstetric outcomes: hypertensive disorders of pregnancy (gestational hypertension and pre-eclampsia) (HDP), placenta previa, placenta abruption, postpartum hemorrhage (PPH).","definition_or_measurement_approach":"Obstetric outcomes recorded according to clinical diagnoses: HDP (gestational hypertension and pre-eclampsia), placenta previa, placental abruption, postpartum hemorrhage."}
- {"endpoint_text":"- Cost-effectiveness","definition_or_measurement_approach":"Economic evaluation comparing costs and outcomes between treatment groups (no additional methodological details provided)."}
- {"endpoint_text":"- Progesterone levels in blood samples from day LH+3","definition_or_measurement_approach":"Progesterone concentration measured in blood samples taken on day LH+3."}
Recruitment
- Planned Sample Size
- 1800
- Recruitment Window Months
- 57
- Consent Approach
- Participants must give informed consent (inclusion criterion: 'Given informed consent'). Participants must understand written and spoken Swedish, English or Arabic. No further details on assent or surrogate consent provided; all participants are adults (Age≥18).
Geography
- Total Number Of Sites
- 11
- Total Number Of Participants
- 1800
Iceland
- Earliest CTIS Part Ii Submission Date
- 14-03-2024
- Latest Decision Or Authorization Date
- 15-07-2024
- Processing Time Days
- 123
- Number Of Sites
- 1
- Number Of Participants
- 100
Sites
- Site Name
- Livio Reykjavik
- Department Name
- Livio Reykjavik
- Principal Investigator Name
- Kristbjörg Heidur Olsen
- Principal Investigator Email
- reykjavik@livio.is
- Contact Person Name
- Kristbjörg Heidur Olsen
- Contact Person Email
- reykjavik@livio.is
Sweden
- Earliest CTIS Part Ii Submission Date
- 14-03-2024
- Latest Decision Or Authorization Date
- 26-06-2024
- Processing Time Days
- 104
- Number Of Sites
- 10
- Number Of Participants
- 1700
Sites
- Site Name
- Sahlgrenska University Hospital-Vaestra Goetalandsregionen
- Department Name
- Dept of Gynecology and Reproductive Medicine, Blå Stråket 6, 41345 Gothenburg
- Principal Investigator Name
- Åsa Magnusson
- Principal Investigator Email
- asa.magnusson@vgregion.se
- Contact Person Name
- Åsa Magnusson
- Contact Person Email
- asa.magnusson@vgregion.se
- Site Name
- Livio Umeå
- Department Name
- Livio Fertilitetscentrum Umeå
- Principal Investigator Name
- Sofia De Sousa Soares
- Principal Investigator Email
- umea@livio.se
- Contact Person Name
- Sofia De Sousa Soares
- Contact Person Email
- umea@livio.se
- Site Name
- Karolinska University Hospital
- Department Name
- Section of Reproductive Medicine, Novumhuset, 141 86 Stockholm
- Principal Investigator Name
- Kenny A. Rodriguez-Wallberg
- Principal Investigator Email
- kenny.rodriguez-wallberg@ki.se
- Contact Person Name
- Kenny A. Rodriguez-Wallberg
- Contact Person Email
- kenny.rodriguez-wallberg@ki.se
- Site Name
- Region Skane Skanes Universitetssjukhus
- Department Name
- Reproduktionsmedicinskt centrum (RMC), Jan Waldenströms gata 47, 205 02 Malmö
- Principal Investigator Name
- Margareta Kitlinski
- Principal Investigator Email
- margareta.kitlinski@skane.se
- Contact Person Name
- Margareta Kitlinski
- Contact Person Email
- margareta.kitlinski@skane.se
- Site Name
- Region Oerebro Laen
- Department Name
- Universitetssjukhuset Örebro, Fertilitetsenheten, Kvinnokliniken, 701 85 Örebro
- Principal Investigator Name
- Gabriella Widlund
- Principal Investigator Email
- gabriella.widlund@regionorebrolan.se
- Contact Person Name
- Gabriella Widlund
- Contact Person Email
- gabriella.widlund@regionorebrolan.se
- Site Name
- Livio Fertilitetscentrum AB Göteborg
- Department Name
- Livio Fertilitetscentrum AB Göteborg
- Principal Investigator Name
- Göran Westlander
- Principal Investigator Email
- goran.westlander@livio.se
- Contact Person Name
- Göran Westlander
- Contact Person Email
- goran.westlander@livio.se
- Site Name
- IVF-gruppen vid Sophiahemmet AB
- Department Name
- IVF-gruppen vid Sophiahemmet
- Principal Investigator Name
- Arthur Aanesen
- Principal Investigator Email
- ivfsekr.sophiahemmet@livio.se
- Contact Person Name
- Arthur Aanesen
- Contact Person Email
- ivfsekr.sophiahemmet@livio.se
- Site Name
- Region Oestergoetland
- Department Name
- Universitetssjukhuset i Linköping, Avd. Obstetrik och Gynekologi, 58185 Linköping
- Principal Investigator Name
- Susanne Liffner
- Principal Investigator Email
- susanne.m.liffner@regionostergotland.se
- Contact Person Name
- Susanne Liffner
- Contact Person Email
- susanne.m.liffner@regionostergotland.se
- Site Name
- Livio Falun AB
- Department Name
- Livio Falun
- Principal Investigator Name
- Bo Claesson
- Principal Investigator Email
- falun@livio.se
- Contact Person Name
- Bo Claesson
- Contact Person Email
- falun@livio.se
- Site Name
- Nordic IVF Sverige AB
- Department Name
- Nordic IVF Sverige AB
- Principal Investigator Name
- Mats Brännström
- Principal Investigator Email
- info@stockholmivf.se
- Contact Person Name
- Mats Brännström
- Contact Person Email
- info@stockholmivf.se
Sponsor
Primary sponsor
- Full Name
- Vaestra Goetalandsregionen
- Organisation Type
- Hospital/Clinic/Other health care facility
- Country Of Registered Address
- Sweden
Investigational products
- Investigational Product Name
- Cyclogest 400 mg vagitorium
- Active Substance
- Progesterone
- Modality
- Small molecule
- Routes Of Administration
- VAGINAL USE
- Route
- Vaginal
- Authorisation Status
- Authorised (product EV code PRD7275307, marketingAuthNumber 54305)
- Starting Dose
- 400 mg
- Dose Levels
- 400 mg pessary; max daily dose 800 mg; max total dose 39200 mg; max treatment period 7 (time unit code 2)
- Maximum Dose
- 800 mg (max daily)
- Investigational Product Name
- Lutinus 100 mg vaginaltabletter
- Active Substance
- Progesterone
- Modality
- Small molecule
- Routes Of Administration
- VAGINAL USE
- Route
- Vaginal
- Authorisation Status
- Authorised (product EV code PRD475933, marketingAuthNumber 26884)
- Starting Dose
- 100 mg
- Dose Levels
- 100 mg tablet; max daily dose 300 mg; max total dose 14700 mg; max treatment period 7 (time unit code 2)
- Maximum Dose
- 300 mg (max daily)
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