E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
The research population consists of infertile couples who have tried to conceive for at least 12 months, or have oligo- or anovulation. We will focus on women with ovulation disorders, or at high risk for tubal pathology or above 38 years of age. |
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E.1.1.1 | Medical condition in easily understood language |
The research population consists of infertile couples who have tried to conceive for at least 12 months or have an irregular menstrual cycle or at high risk for tubal pathology or >38 years of age. |
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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 objective of the proposed study is to assess the effectiveness and cost-effectiveness of the use of oil versus water-based contrast medium in terms of conception leading to live birth in women undergoing HSG, who:
1: have ovulation disorders or;
2: are at high risk for tubal pathology or;
3: are above 38 years of age.
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E.2.2 | Secondary objectives of the trial |
Treatment outcome parameters:
- Biochemical pregnancy
- Clinical pregnancy
- Ongoing pregnancy
- Miscarriage
- Ectopic pregnancy
- Multiple pregnancy
- Time to pregnancy
- Complications following HSG (infection, intravastion)
- Pregnancy outcomes (f.e. birth weight)
- Pregnancy complications
- Stillbirth
- Thyroid function of the woman (before and 1 month after HSG)
- Neonatal outcomes
- Additional fertility treatments (Intra-uterine insemination, IVF, IVF/ICSI)
- Costs within 6 months after randomization
- Thyroid function of neonate (determined by heelprick) |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
In order to be eligible to participate in this study, a women must meet one of the following criteria:
1: with ovulation disorders (ovulation disorders will be defined as less than 8 menstrual cycles per year) or;
2: at high risk for tubal pathology (high risk for tubal pathology will be defined as a positive chlamydia infection, a pelvic inflammatory disease, known endometriosis, abdominal surgery (including tubectomy for ectopic pregnancy and appendectomy) and/or peritonitis in the medical history) or;
3: above 38 years of age
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E.4 | Principal exclusion criteria |
- Iodine allergy
- Male subfertility defined as a post-wash total motile sperm count < 1 x10^6 spermatozoa/ml
- Not willing or able to sign the consent form
- Endocrine disorders as diabetes, hyperthyroidism or hyperprolactinemia (except for well managed hypothyroidism with TSH between 0.3 and 2.5mIU/l) |
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary outcome is conception leading to live birth, with a positive pregnancy test preceding the pregnancy within 6 months after randomization. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
6 months after randomization, unless a patiente is pregnant within the 6 months follow-up, then she will be followed until the end of the pregnancy. |
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E.5.2 | Secondary end point(s) |
Treatment outcome parameters:
- Biochemical pregnancy
- Clinical pregnancy
- Ongoing pregnancy
- Miscarriage
- Ectopic pregnancy
- Multiple pregnancy
- Time to pregnancy
- Complications following HSG (infection, intravastion)
- Pregnancy outcomes (f.e. birth weight)
- Pregnancy complications
- Stillbirth
- Thyroid function of the woman (before and 1 month after HSG)
- Neonatal outcomes
- Additional fertility treatments (Intra-uterine insemination, IVF, IVF/ICSI)
- Costs within 6 months after randomization
- Thyroid function of neonate (determined by heelprick) |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
T0: Time of randomization
T1: Six months after randomization, unless a patient is pregnant within the 6 months follow-up, then she will be followed until the end of the pregnancy. |
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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 | Yes |
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 | Yes |
E.6.13.1 | Other scope of the trial description |
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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 | 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 |
An HSG with a water-based contrast depending on local protocol. |
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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
| 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 | 5 |
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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6 months after randomization, unless a patiente is pregnant within the 6 months follow-up, then she will be followed until the end of the pregnancy. |
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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 | |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |