Clinical trial • Phase IV • Other
Estradiol valerate for Subfertility
Phase IV trial of Estradiol valerate for Subfertility.
Overview
- Trial Therapeutic Area
- Other
- Trial Disease
- Subfertility
- Trial Stage
- Phase IV
- Drug Modality
- Small molecule
Key dates
- Initial CTIS Submission Date
- 17-01-2025
- First CTIS Authorization Date
- 22-01-2025
Trial design
Randomised, randomized comparison of frozen-thawed embryo transfer in a natural cycle versus an artificial cycle (no drug name/dose/schedule specified in part i text).-controlled Phase IV trial across 5 sites in Belgium.
- Randomised
- Yes
- Comparator
- Randomized comparison of frozen-thawed embryo transfer in a natural cycle versus an artificial cycle (no drug name/dose/schedule specified in Part I text).
- Target Sample Size
- 554
Eligibility
Recruits 554 No vulnerable populations selected; trial enrols adult female participants (age 18-45); written informed consent is required. Subject information and informed consent forms are available (documents: L1_ICF DUT, L1_ICF FR, L1_ICF EN)..
- Vulnerable Population
- No vulnerable populations selected; trial enrols adult female participants (age 18-45); written informed consent is required. Subject information and informed consent forms are available (documents: L1_ICF DUT, L1_ICF FR, L1_ICF EN).
Inclusion criteria
- {"criterion_text":"- \tWomen undergoing FET after a first, second or third fresh IVF/ICSI cycle\n- \tSingle embryo transfer (SET) or Double embryo transfer (DET)\n- \tFemale age between 18-45 year\n- \tWomen having a natural ovulatory cycle (24-35 days)\n- \tNormal uterine cavity (fundal indentation at the cavity <10mm)\n- \tWritten informed consent"}
Exclusion criteria
- {"criterion_text":"- \tUse of donor gametes\n- \tBMI > or equal to 35 kg / m2\n- \tAny contra-indication to estrogen or progesterone supplementation (e.g. history of thrombosis, prior or current hormone-sensitive malignancy…)"}
Endpoints
Primary endpoints
- {"endpoint_text":"- Clinical pregnancy rate with fetal heart beat","definition_or_measurement_approach":""}
Secondary endpoints
- {"endpoint_text":"- 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","definition_or_measurement_approach":""}
- {"endpoint_text":"- 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)","definition_or_measurement_approach":""}
Recruitment
- Planned Sample Size
- 554
- Recruitment Window Months
- 91
- Consent Approach
- Written informed consent is required. Subject information and informed consent forms are available in Dutch (DUT), French (FR) and English (EN). Consent provided by the adult participant (female).
Geography
- Total Number Of Sites
- 5
- Total Number Of Participants
- 554
Belgium
- Earliest CTIS Part Ii Submission Date
- 17-01-2025
- Latest Decision Or Authorization Date
- 22-01-2025
- Processing Time Days
- 5
- Number Of Sites
- 5
- Number Of Participants
- 554
Sites
- Site Name
- Ziekenhuis Aan De Stroom
- Department Name
- gynaecology
- Principal Investigator Name
- Peter De loecker
- Principal Investigator Email
- peter.deloecker@zas.be
- Contact Person Name
- Peter De loecker
- Contact Person Email
- peter.deloecker@zas.be
- Site Name
- UZ Leuven
- Department Name
- gynaecology
- Principal Investigator Name
- Karen Peeraer
- Principal Investigator Email
- karen.peeraer@uzleuven.be
- Contact Person Name
- Karen Peeraer
- Contact Person Email
- karen.peeraer@uzleuven.be
- Site Name
- Jessa Ziekenhuis
- Department Name
- gynaecology
- Principal Investigator Name
- Sofie Hulsbosch
- Principal Investigator Email
- sofie.hulsbosch@jessazh.be
- Contact Person Name
- Sofie Hulsbosch
- Contact Person Email
- sofie.hulsbosch@jessazh.be
- Site Name
- Clinique Saint-Jean Kliniek Sint-Jan
- Department Name
- gynaecology
- Principal Investigator Name
- Luc Meeuwis
- Principal Investigator Email
- luc.meeuwis@uzleuven.be
- Contact Person Name
- Luc Meeuwis
- Contact Person Email
- luc.meeuwis@uzleuven.be
- Site Name
- Imelda
- Department Name
- gynaecology
- Principal Investigator Name
- Sofie Pelckmans
- Principal Investigator Email
- sofie.pelckmans@imelda.be
- Contact Person Name
- Sofie Pelckmans
- Contact Person Email
- sofie.pelckmans@imelda.be
Sponsor
Primary sponsor
- Full Name
- UZ Leuven
- Organisation Type
- Hospital/Clinic/Other health care facility
- Country Of Registered Address
- Belgium
Investigational products
- Investigational Product Name
- Progynova 2 mg dragerade tabletter
- Active Substance
- Estradiol valerate
- Modality
- Small molecule
- Routes Of Administration
- Oral
- Route
- Oral
- Authorisation Status
- Authorised
- Maximum Dose
- 8 mg
- Investigational Product Name
- Utrogestan 200 mg capsule molli vaginali
- Active Substance
- Progesterone, micronised
- Modality
- Small molecule
- Routes Of Administration
- Vaginal
- Route
- Vaginal
- Authorisation Status
- Authorised
- Maximum Dose
- 600 mg
- Combination Treatment
- Yes
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