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

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

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2020-005552-38-SE

Enrollment

1800

Registered

2020-12-01

Start date

2021-01-27

Completion date

Unknown

Last updated

2024-07-08

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

Conditions

infertility

Interventions

Trade Name: Lutinus Product Name: Lutinus Pharmaceutical Form: Vaginal tablet INN or Proposed INN: PROGESTERONE CAS Number: 57-83-0 Other descriptive name: Lutinus Concentration unit: mg milligram(s)

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: • Planned for a FET-NC • Age=18=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: • 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. • Drugrelated: 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.

Design outcomes

Primary

Measure	Time frame
Main Objective: 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 Objective: -To compare treatment groups regarding: 1. Pregnancy outcomes including biochemical, clinical, ongoing and term pregnancy rates, as well as rates of miscarriage, termination of pregnancy and ectopic pregnancy. 2. Perinatal and obstetric outcomes. 3. Self-reported side effects and adverse events 4. Cost effectiveness. -To analyze the effect of S-progesterone level before FET on the chance of achieving live birth and secondary pregnancy outcomes. ;Primary end point(s): Live birth;Timepoint(s) of evaluation of this end point: Time point of delivery	—

Measure

Time frame

Main Objective: 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 Objective: -To compare treatment groups regarding: 1. Pregnancy outcomes including biochemical, clinical, ongoing and term pregnancy rates, as well as rates of miscarriage, termination of pregnancy and ectopic pregnancy. 2. Perinatal and obstetric outcomes. 3. Self-reported side effects and adverse events 4. Cost effectiveness. -To analyze the effect of S-progesterone level before FET on the chance of achieving live birth and secondary pregnancy outcomes. ;Primary end point(s): Live birth;Timepoint(s) of evaluation of this end point: Time point of delivery

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Secondary

Measure	Time frame
Secondary end point(s): 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), 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 analysis (will be described in a separate study protocol later) Progesterone levels in blood samples from day LH+3 will be measured and used as covariate in the analyses. ;Timepoint(s) of evaluation of this end point: From 12 Days after frozen embryo transfer (FET) until one week after delivery	—

Measure

Time frame

Secondary end point(s): 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), 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 analysis (will be described in a separate study protocol later) Progesterone levels in blood samples from day LH+3 will be measured and used as covariate in the analyses. ;Timepoint(s) of evaluation of this end point: From 12 Days after frozen embryo transfer (FET) until one week after delivery

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Countries

Iceland, Sweden

Contacts

Public ContactChristina Bergh

Västra Götalandsregionen

christina.bergh@vgregion.se+46736889325

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026