E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Sub-infertility due to endometriosis |
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E.1.1.1 | Medical condition in easily understood language |
Inability to become pregnant, probably caused by the presence of endometriosis which is a disease in which the cells which line the uterus (womb)are present outside the uterus. |
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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 | 14.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10016402 |
E.1.2 | Term | Female infertility of pituitary-hypothalamic origin |
E.1.2 | System Organ Class | 100000004872 |
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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 primary objective of this study is to determine if pre-treatment with oral contraceptives improves IVF or IVF-ICSI success rates (i.e. live birth rates) in patients who suffer from endometriosis. |
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E.2.2 | Secondary objectives of the trial |
The secondary objectives are to determine if pre-treatment with oral contracaptives improves other measures of IVF or IVF-ICSI success rates in patients who suffer from endometriosis such as • Ovarian response (how many eggs are produced) • Cancellation rate (how many IVF/IVF-ICSI cycles are cancelled) • Clinical pregnancy rate • Multiple pregnancy • Ectopic pregnancy • Ovarian hyperstimulation syndrome (OHSS) |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
• Participant is willing and able to give informed consent for participation in the study. • Female aged 18 to 39 years old. • Intending to undergo treatment with a first, second or third cycle of IVF or IVF-ICSI. • Diagnosed with any degree of endometriosis. • Participants must meet World Health Organisation Group 1 or 2 eligibility requirements for Combined Oral Contraceptive use. |
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E.4 | Principal exclusion criteria |
• The participant does not understand the English language, or has special communication needs. This is because it is impractical to provide, for this small scale study, information sheets and consent forms in other languages except English. • The patient has already undergone 3 or more IVF or IVF-ICSI cycles. • Patients who are already taking any medication to treat endometriosis such as progestins, OCP, GnRH agonists, danazol, mirena, etc. or who have done so within the last 3 months. • Participants who do not meet World Health Organisation Group 1 or 2 eligibility requirements for Combined Oral Contraceptive use. |
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E.5 End points |
E.5.1 | Primary end point(s) |
• Live birth, which is defined as the birth of a live child after 24 gestational weeks. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
This end point may be up to approximately 30 weeks after the last study visit of each study participant (the last study visit is a pregnancy scan at around 8 weeks gestation and pregnancy can last up to 42 weeks until birth). |
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E.5.2 | Secondary end point(s) |
• Treatment response per cycle: o No. of follicles aspirated o No. of oocytes retrieved o No. of cleavage embryos (i.e. fertilized egg starting to divide) obtained o Total dose and duration of Gonadotrophin • Other cycle outcomes: o Failed cycle (negative pregnancy test) o Biochemical pregnancy only (positive pregnancy test but not clinical pregnancy) o Clinical pregnancy (defined as intra-uterine pregnancy with positive fetal heart activity at 6 gestational weeks). o Miscarriage (pregnancy loss up to 24 weeks gestation) o Stillbirth o Cycle cancellation • Number of cases of OHSS • Multiple pregnancy rate • Number of Ectopic pregnancies |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
All secondary endpoints are after treatment (with IMP) has been completed. The secondary end points are obtained during treatment cycles: Ovarian response - 24 hours after egg collection procedure Biochemical pregnancy - 2 weeks after embryo transfer Cycle cancellation - any point up to embryo transfer procedure clinical/multiple pregnancies - 4 weeks after embryo transfer |
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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) | 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 | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | Yes |
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 |
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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.8.4.1 | Number of sites anticipated in Member State concerned | 1 |
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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End of trial is defined as when the treatment outcome for the last subject is known (this could be up to approximately 30 weeks following the last visit of the last subject if they are pregnant, since we are collecting live birth data and the last visit is a pregnancy scan at 8 weeks gestation and a gestation is around 37-42 weeks). |
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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 |