GalactosemiasNCT02091128
Pregnancy Chances in Classic Galactosemia
An observational study of Galactosemias and Primary Ovarian Insufficiency, run by Maastricht University Medical Center at 1 site in Netherlands.
Trial summary
With this study, in which the incidence of pregnancy in classic galactosemia patients is studied, we aim to provide new insights to improve counselling. Our hypothesis is that the chance that a galactosemic woman with POI becomes pregnant is higher than the 5-10% that has been reported for women with POI due to other… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Galactosemias, Primary Ovarian Insufficiency
- How many people
- 85 participants
- Where
- 1 siteNetherlands
- Study dates
- Mar 2014to Sep 2016
- Phase
- Observational
- 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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Academic hospital
Who may be able to join
- Classic galactosemia diagnosed by GALT enzyme activity assay or GALT-gene mutation analysis
- Eighteen years of age or older
- Diagnosed with POI defined as symptoms of hypergonadotrophic hypogonadism measured by serum concentrations of FSH and estradiol
- Capable of giving informed consent
Who cannot join
- Any known congenital or acquired disease or disorder negatively affecting pubertal development and/or fertility.
Trial locations and contacts
1 site in 1 country.
About this study
With this study, in which the incidence of pregnancy in classic galactosemia patients is studied, we aim to provide new insights to improve counselling. Our hypothesis is that the chance that a galactosemic woman with POI becomes pregnant is higher than the 5-10% that has been reported for women with POI due to other causes. Chance of spontaneous pregnancy will be evaluated through semi standardized interview in women with classic galactosemia aged 18 years or older. During the interview, questions will be asked regarding fertility and pregnancy.
- Conditions
- Galactosemias, Primary Ovarian Insufficiency
- Medical subject headings
- Galactosemias, Primary Ovarian Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Females with classic galactosemia and POI | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pregnancy incidence despite POI diagnosis
Will be assessed during semi-standardized interview
Measured: day 1
Secondary outcomes (4)
Whether women have tried to conceive
Will be assessed during semi-standardized interview
Measured: day 1
Time to pregnancy (in case a participant has been pregnant)
Will be assessed during semi-standardized interview
Measured: day 1
Menstrual history
Will be assessed during semi-standardized interview
Measured: day 1
Hormonal replacement therapy usage
Will be assessed during semi-standardized interview
Measured: day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2014 (estimated)
- Study startMar 2014
- Primary completionSep 2016
- Study completionSep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for GalactosemiasStudies of the same condition, open and under way.
- More trials run by Maastricht University Medical CenterThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 85 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- M. Estela Rubio-Gozalbo, Dr, Principal investigator, Maastricht University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02091128
- Sponsor's protocol ID
- METC 13-4-127
- Status last verified
- Sep 2016
- First submitted
- 13 Mar 2014
- Last updated
- 13 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Gubbels CS, Land JA, Rubio-Gozalbo ME. Fertility and impact of pregnancies on the mother and child in classic galactosemia. Obstet Gynecol Surv. 2008 May;63(5):334-43. doi: 10.1097/OGX.0b013e31816ff6c5.
PubMed 18419833
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pregnancy Chances in Classic Galactosemia
- ClinicalTrials.gov ID
- NCT02091128
- Acronym / sponsor ID
- METC 13-4-127
- Conditions
- Galactosemias, Primary Ovarian Insufficiency
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 85 participants (actual)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Study start
- Mar 2014
- Primary completion
- Sep 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 19 Mar 2014 (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.
With this study, in which the incidence of pregnancy in classic galactosemia patients is studied, we aim to provide new insights to improve counselling. Our hypothesis is that the chance that a galactosemic woman with POI becomes pregnant is higher than the 5-10% that has been reported for women with POI due to other causes. Chance of spontaneous pregnancy will be evaluated through semi standardized interview in women with classic galactosemia aged 18 years or older. During the interview, questions will be asked regarding fertility and pregnancy.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Females with classic galactosemia and POI | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Academic hospital
Key inclusion criteria (4 listed)
- Classic galactosemia diagnosed by GALT enzyme activity assay or GALT-gene mutation analysis
- Eighteen years of age or older
- Diagnosed with POI defined as symptoms of hypergonadotrophic hypogonadism measured by serum concentrations of FSH and estradiol
- Capable of giving informed consent
Key exclusion criteria (1 listed)
- Any known congenital or acquired disease or disorder negatively affecting pubertal development and/or fertility.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Pregnancy incidence despite POI diagnosis
Time frame: day 1
Will be assessed during semi-standardized interview
4 secondary outcomes
Whether women have tried to conceive
Time frame: day 1
Time to pregnancy (in case a participant has been pregnant)
Time frame: day 1
Menstrual history
Time frame: day 1
Hormonal replacement therapy usage
Time frame: day 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2016.
- Background: PubMed 18419833Gubbels CS, Land JA, Rubio-Gozalbo ME. Fertility and impact of pregnancies on the mother and child in classic galactosemia. Obstet Gynecol Surv. 2008 May;63(5):334-43. doi: 10.1097/OGX.0b013e31816ff6c5.
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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.
M. Estela Rubio-Gozalbo, Dr principal investigator
Maastricht University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Galactosemias and Primary Ovarian Insufficiency, run by Maastricht University Medical Center at 1 site in Netherlands.
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 4 inclusion and 1 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: finished, as of the sponsor's last update on 13 Sep 2016. 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 Netherlands. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pregnancy incidence despite POI diagnosis (time frame: day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02091128, which also lists 1 linked publication.
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 13 Sep 2016.