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Vaginal progesterone as luteal support for improvement of live birth in frozen/thawed in-vitro fertilization natural cycles; a multicenter, open, randomized trial

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-512844-40-00
Acronym
ProFET
Enrollment
1800
Registered
2024-06-26
Start date
2021-04-20
Completion date
Unknown
Last updated
2024-07-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infertility

Brief summary

Live birth

Detailed description

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

Interventions

DRUGCyclogest 400 mg vagitorium
DRUGLutinus 100 mg vaginaltabletter

Sponsors

Vaestra Goetalandsregionen
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to 64 Years

Design outcomes

Primary

MeasureTime frame
Live birth

Secondary

MeasureTime frame
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

Countries

Iceland, Sweden

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026