E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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E.1.1.1 | Medical condition in easily understood language |
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E.1.1.2 | Therapeutic area | Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13] |
MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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. |
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E.2.2 | Secondary objectives of the trial |
-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.
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
• Planned for a FET-NC • 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 • FET of blastocyst
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E.4 | Principal 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.
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E.5 End points |
E.5.1 | Primary end point(s) |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | 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.
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E.5.2.1 | 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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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | No |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 3 |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 9 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 1 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | Yes |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 2 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |