Abortion, RecurrentPhase 2NCT01175759
Role of Hypersensitivity to Female Sex Hormones in Women With Unexplained Recurrent Pregnancy Loss
A Phase 2 study testing Skin test panel in people with Abortion, Recurrent, run by EVE Medical Systems Ltd. at 1 site in Hungary.
Trial summary
The EVE- technology is intended for determination of intolerance or sensitivity to female sex hormones among women with hormone-related conditions and for further treatment by desensitization procedure inducing a tolerance to the hormones the women are sensitive to. Read more about this study
- Who is it for?
- Ages 20 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Abortion, Recurrent
- What is being tested?
- Skin test panel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteHungary
- Study dates
- Jun 2010to Dec 2011
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- For both groups:
- Between ages of 20 to 40
- Willing to participate as shown by signing the informed consent form.
- For healthy group:
- Parous subjects without premenstrual syndrome, as per medical history and subject's report ( PMS questionnaire)
- For UPRL:
- Women with three or more documented early pregnancy losses.
Who cannot join
- For both groups:
- No hormonal contraceptives (either OC or hormonal IUD (Mirena)), no psychotropic agents (e.g. Antidepressants, anxiolytics, or lithium carbonate) for at least two months prior to screening.
- No hormonal therapy (estrogen or progesterone) for at least two months prior to screening.
- Significant medical or psychiatric disease.
- Severe allergies or an inflammatory illness at the time of enrollment
- For healthy group:
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- Women who are pregnant or lactating on the day of screening
- Abnormal routine blood tests
- For UPRL:
- Hereditary thrombophilias (Factor V Leiden, Activated protein C resistance, MTHFR (C677T), Factor II mutation (G20201A))
- One or more abnormal test from the list below:
- Karyotype of either parent (normal: 46XX or 46XY)
- Glucose tolerance test (This can be altered to fasting blood sugar of 100mg/dl or less);
- Toxoplasmosis serology (IgM positive);
- Hysterosalpingogram, 3-D ultrasound or hysteroscopy, thereby excluding anatomical abnormalities, intrauterine adhesions and cervical incompetence;
- Thyroid function (Euthyroid levels;);
- Serum prolactin;
- Normal luteal phase of at least 12 days and plasma progesterone above 24 ng/lL
- Anti nuclear factor (Negative)
- Anticardiolipin antibody by Elisa testing (cut off value <13 GPLu/mL and <7.6 MPLu/mlL) and Lupus anticoagulant (according to Kaolin clotting time (KCT), Russell's viper venom tome (RVVT) or APTT.
Trial locations and contacts
1 site in 1 country.
Hungary1 site, 1 recruiting
- Recruiting
Depts. Gynecology and Obstetrics and 3rd Dept of Internal Medicine
Budapest, H1125
George Füst, Prof., 361-212-9351, fustge@kut.sote.hu
János Rigó, Prof.
About this study
Official title: Evaluation of the Efficacy and Safety of the EVE- Skin-Test Panel in Detecting Sensitivity to Sex Hormones in Women With Unexplained Recurrent Pregnancy Loss
The EVE- technology is intended for determination of intolerance or sensitivity to female sex hormones among women with hormone-related conditions and for further treatment by desensitization procedure inducing a tolerance to the hormones the women are sensitive to.
This study is designed to evaluate the safety and the ability of the EVE- Skin-Test Panel to detect sensitivity to female sex hormones in subjects with Unexplained Recurrent Pregnancy Loss (URPL) and in Control parous, healthy women.
Read more
The Skin Test Panel includes four female hormones and three control solutions.
Hormones from the Skin Test Panel are injected intradermally during the luteal phase of the subject's menstrual cycle. The skin reactions are examined by physician for erythema and wheal after 20 minutes and 48 hours and self-assessed by the patient daily for the following month.
Skin response monthly data is analyzed and compared between unexplained recurrent pregnancy loss (UPRL) and healthy groups.
Following achievement of the significant differences between both groups the immune profile of the healthy and UPRL subjects will be investigated.
- Conditions
- Abortion, Recurrent
- Being tested
- Skin test panel
- Keywords
- Unexplained Recurrent Pregnancy Loss, Recurrent Abortions, Recurrent Miscarriages, Hormones, Skin tests, Allergen, Immunotherapy, Hypersensitivity, Skin reaction
- Medical subject headings
- Abortion, Habitual, Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Skin test panelDrug
Skin testing 4 sex hormones will be performed during the luteal phase of the subject's menstrual cycle by study investigators.
Hormones:
- Progesterone 1mmol/L
- Estradiol 1mmol/L
- Estrone 3mmol/L
- Estriol 3mmol/l Controls:
- Saline (NaCl) 0.9%
- Ethyl Oleate with 10% Benzyl Alcohol
- Histamine phosphate 1mg/ml (epicutaneous- prick test)
Skin test panelDrug
Skin testing 4 sex hormones will be performed during the luteal phase of the subject's menstrual cycle by study investigators.
Hormones:
- Progesterone 1mmol/L
- Estradiol 1mmol/L
- Estrone 3mmol/L
- Estriol 3mmol/l Controls:
- Saline (NaCl) 0.9%
- Ethyl Oleate with 10% Benzyl Alcohol
- Histamine phosphate 1mg/ml (epicutaneous- prick test)
| Study group | Role | What they receive |
|---|---|---|
| Healthy control group | Experimental | Not described Receives: Drug: Skin test panel |
| UPRL | Experimental | Not described Receives: Drug: Skin test panel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of subjects with positive wheal responses to the Skin Test Panel in URPL and Control groups
Measured: 1 month
Secondary outcomes (2)
Frequency and severity of adverse events following a skin test procedure in subjects from URPL and Control groups
Measured: 1 month
Measurement of cytokine production in subjects from UPRL and Control groups
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2010 (estimated)
- Study startJun 2010
- Primary completionJun 2011 (estimated)
- Study completionDec 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Abortion, RecurrentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- EVE Medical Systems Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Semmelweis University
- Investigators
- János Rigó, Prof., Principal investigator, Gynecology and Obstetrics Dept, Semmelweis University, Budapest, HungaryHenriette Farkas, Prof., Principal investigator, 3rd Dept of Internal Medicine, Semmelweis University, Budapest, Hungary
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01175759
- Sponsor's protocol ID
- 34/2009
- Status last verified
- Jun 2010
- First submitted
- 15 Jun 2010
- Last updated
- 5 Aug 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Efficacy and Safety of the EVE- Skin-Test Panel in Detecting Sensitivity to Sex Hormones in Women With Unexplained Recurrent Pregnancy Loss
- ClinicalTrials.gov ID
- NCT01175759
- Acronym / sponsor ID
- 34/2009
- Conditions
- Abortion, Recurrent
- Keywords
- Unexplained Recurrent Pregnancy Loss, Recurrent Abortions, Recurrent Miscarriages, Hormones, Skin tests, Allergen, Immunotherapy, Hypersensitivity
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- EVE Medical Systems Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Semmelweis University
- Study start
- Jun 2010
- Primary completion
- Jun 2011 (estimated)
- Study completion
- Dec 2011 (estimated)
- First posted
- 5 Aug 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The EVE- technology is intended for determination of intolerance or sensitivity to female sex hormones among women with hormone-related conditions and for further treatment by desensitization procedure inducing a tolerance to the hormones the women are sensitive to.
This study is designed to evaluate the safety and the ability of the EVE- Skin-Test Panel to detect sensitivity to female sex hormones in subjects with Unexplained Recurrent Pregnancy Loss (URPL) and in Control parous, healthy women.
The Skin Test Panel includes four female hormones and three control solutions.
Hormones from the Skin Test Panel are injected intradermally during the luteal phase of the subject's menstrual cycle. The skin reactions are examined by physician for erythema and wheal after 20 minutes and 48 hours and self-assessed by the patient daily for the following month.
Skin response monthly data is analyzed and compared between unexplained recurrent pregnancy loss (UPRL) and healthy groups.
Following achievement of the significant differences between both groups the immune profile of the healthy and UPRL subjects will be investigated.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy control group | Experimental | Drug: Skin test panel |
| UPRL | Experimental | Drug: Skin test panel |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Between ages of 20 to 40
- Willing to participate as shown by signing the informed consent form.
- Parous subjects without premenstrual syndrome, as per medical history and subject's report ( PMS questionnaire)
- Women with three or more documented early pregnancy losses.
Key exclusion criteria (20 listed)
- No hormonal contraceptives (either OC or hormonal IUD (Mirena)), no psychotropic agents (e.g. Antidepressants, anxiolytics, or lithium carbonate) for at least two months prior to screening.
- No hormonal therapy (estrogen or progesterone) for at least two months prior to screening.
- Significant medical or psychiatric disease.
- Severe allergies or an inflammatory illness at the time of enrollment
- Women who are pregnant or lactating on the day of screening
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Skin test panelSkin testing 4 sex hormones will be performed during the luteal phase of the subject's menstrual cycle by study investigators. Hormones: 1. Progesterone 1mmol/L 2. Estradiol 1mmol/L 3. Estrone 3mmol/L 4. Estriol 3mmol/l Controls: 5. Saline (NaCl) 0.9% 6. Ethyl Oleate with 10% Benzyl Alcohol 7. Histamine phosphate 1mg/ml (epicutaneous- prick test) | Drug | Healthy control group |
| Skin test panelSkin testing 4 sex hormones will be performed during the luteal phase of the subject's menstrual cycle by study investigators. Hormones: 1. Progesterone 1mmol/L 2. Estradiol 1mmol/L 3. Estrone 3mmol/L 4. Estriol 3mmol/l Controls: 5. Saline (NaCl) 0.9% 6. Ethyl Oleate with 10% Benzyl Alcohol 7. Histamine phosphate 1mg/ml (epicutaneous- prick test) | Drug | UPRL |
Primary outcome
Number of subjects with positive wheal responses to the Skin Test Panel in URPL and Control groups
Time frame: 1 month
2 secondary outcomes
Frequency and severity of adverse events following a skin test procedure in subjects from URPL and Control groups
Time frame: 1 month
Measurement of cytokine production in subjects from UPRL and Control groups
Time frame: 1 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
János Rigó, Prof. principal investigator
Gynecology and Obstetrics Dept, Semmelweis University, Budapest, Hungary
Henriette Farkas, Prof. principal investigator
3rd Dept of Internal Medicine, Semmelweis University, Budapest, Hungary
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Skin test panel in people with Abortion, Recurrent, run by EVE Medical Systems Ltd. at 1 site in Hungary.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Aug 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hungary. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact George Füst, Prof. (361-212-9351, fustge@kut.sote.hu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of subjects with positive wheal responses to the Skin Test Panel in URPL and Control groups (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2010.