An observational study in Urogenital Abnormalities, Prenatal Disorder and Sex Development Disorder, sponsored by University Hospital, Brest. Completed at 1 site in France. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-01-13.
Sponsored by University Hospital, Brest · Observational
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Among 10 studies in Disorders of Sex Development with a site in France — 1 open to participants now, 1 under way, none of them phase 3. Disorders of Sex Development · France.
Among the 10 studies in Disorders of Sex Development with a site in France, this one is the only one that started in 2019, is one of 7 observational ones, and was the 5th registered.
32 studies on the registry are indexed under Disorders of Sex Development; 7 are open to participants now.
Browse Disorders of Sex Development studies →1 of the 10 studies in Disorders of Sex Development with a site in France is open now. Recruiting first, the newest first:
Fondation Ophtalmologique Adolphe de Rothschild · Sites in France
A study can be open while its sites in France have not opened yet or have stopped. Only those recruiting at a site in France →
Of the 6 Disorders of Sex Development studies recruiting now, 3 set no upper age limit and 2 stop at 75 or younger; 4 take children under 18; 3 take healthy volunteers.
This study: 18 Years and older · female · healthy volunteers too.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
10 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 1 · Phase 2 2
First in 2014; this study’s year is marked. 1 started in 2019.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 318 is above the median of 84 across 17 observational studies indexed under Disorders of Sex Development.
Median enrollment 122 across the 3 interventional studies, 170 across the 7 observational. Of the 8 that completed or were terminated, 2 (25%) have results posted.
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1 of 10 have an industry lead sponsor. The 9 most frequent:
University Hospital, Brest is the lead sponsor of 601 studies on the registry; 136 are open to participants now.
University Hospital, Brest has 1 study filed under Disorders of Sex Development — fewer than ten, so there is no comparison to draw.
1 of the studies in Disorders of Sex Development with a site in France that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT03283852Fondation Ophtalmologique Adolphe de RothschildIdentifying New Genetic Causes to Development Disorders | 2027-02-21 |
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Among the 10 studies in Disorders of Sex Development with a site in France, from their registry updates:
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The purpose of this study is to determine a threshold value of fetal anogenital distance in 2D ultrasound to differentiate male fetuses from female fetuses, starting 18 weeks of gestation and until the due date.
The study also evaluates the feasibility of the measure and its interobserver variability.
The anogenital distance of female newborns is shorter than that of male newborns.
Urogenital disorders, such as hypospadias and micro-penis, are associated with a shorter anogenital distance.
Anogenital distance is a good marker of fetal exposure to androgenic substances.
Prenatal anogenital distance ultrasound measure can help the diagnosis in case of doubt about fetal sexual phenotype or in case of urogenital disorder suspicion (hypospadias or micropenis).
Is the anogenital distance easy to make measure? Can this procedure be reproduced? What are the threshold values to determine fetal sex at each term of pregnancy?
All pregnant women follow up at Brest Hospital to 18 weeks of gestation until term, except suspicion of fetal pelvic malformations and patients without an exact echographic datation of pregnancy between 11 and 13+6 weeks of gestation.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
fetal anogenital distance
The distance will be measured from the center of the anus to the posterior convergence of the fourchette in female fetuses and to the posterior base of the scrotum in male fetuses
Time frame: During fetal ultrasound exam
Interobserver variability
reproducibility of the anogenital measure: the measure will be taken by two sonographers during the same exam
Time frame: During fetal ultrasound exam
Ano-genital distance in mm
the measure is correctly performed and validated by an expert
Time frame: During fetal ultrasound exam
Estimated fetal weight
Impact of estimated fetal weight and anogenital distance
Time frame: During fetal ultrasound exam
neonatal sex determination
concordance of anogenital distance and neonatal sex determination
Time frame: During fetal ultrasound exam
Plan to share: Yes — All collected data that underlie results in a publication
Supporting information: Study protocol
Time frame: Data will be available after the publication of result and ending three years maximum following the last visit of the last patient
Access criteria: Data access requests will be reviewed by the internal committee of Brest UH. requestors will be required to sign and complete a data access agreement
No publications or documents are linked to this record.
Ran from Apr 2019 to primary completion in Sep 2021, 28 months.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jan 2021. You cannot join it, but the record below documents what was studied.
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Disorders of Sex Development →