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.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 21.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10021926 |
E.1.2 | Term | Infertility |
E.1.2 | System Organ Class | 10038604 - Reproductive system and breast disorders |
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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 aim of this study is to investigate the effect of adding progesterone rectally in hormone replacement treatment frozen embryo transfer (HRT-FET) cycles if the serum progesterone (P4) is <35nmol/l on embryo transfer day. |
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E.2.2 | Secondary objectives of the trial |
Secondary end-points are positive hCG rate, clinical pregnancy, early pregnancy loss, live birth, mean P4 levels in the groups ≥35nmol/l and <35nmol/l and in the latter group before and after adding rectally progesterone, live birth, side effect to rectally administration of Cyclogest, urine progesterone level, saliva free progesterone level, the vaginal microbiota in relation to serum progesterone level. Side effects and patient convenience regarding rectally administration of Cyclogest. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
• 18-45 years • BMI >18.5 <34 kg/m² • Blastocyst available for transfer after thawing
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E.4 | Principal exclusion criteria |
• Endometrium <7 mm after 12-20 days of 6 mg estradiol treatment. • Previous enrolment in the trial • No blastocyst for transfer • Uterine abnormalities • Oocyte donation • Dysregulated severe chronical medical diseases • Violation of the protocol
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E.5 End points |
E.5.1 | Primary end point(s) |
Ongoing pregnancy rate gestational week 12+0. |
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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) |
Secondary end-points are positive hCG rate, clinical pregnancy, early pregnancy loss, live birth, mean P4 levels in the groups ≥35nmol/l and <35nmol/l and in the latter group before and after adding rectally progesterone, live birth, side effect to rectally administration of Cyclogest, urine progesterone level, saliva free progesterone level, the vaginal microbiota in relation to serum progesterone level. Side effects and patient convenience regarding rectally administration of Cyclogest. |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
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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 | No |
E.6.4 | Safety | No |
E.6.5 | Efficacy | Yes |
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) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | No |
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 | Yes |
E.8.2.3.1 | Comparator description |
Standard Hormonal Replacement treatment with vaginally progesterone application only. |
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E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
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 | No |
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 | 2 |
E.8.9.1 | In the Member State concerned days | |