- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT00006156
Feasibility Study for Development of an Early Test for Ovarian Failure
FSH-Stimulated Inhibin B as a Marker for Early Ovarian Insufficiency
This purpose of this study is to gain information about normal ovarian function that will be useful in developing a test for early detection of ovarian failure. The ovaries produce female hormones, such as estrogen, that are important in maintaining a woman's health. When the ovaries do not work properly, problems can develop. Unfortunately, there is no test that can detect ovarian failure early in its course. By the time premature ovarian failure is diagnosed in young women, two-thirds have already developed osteopenia (loss of some bone mass) and nearly one in ten have osteoporosis, a greater loss of bone mineral density that weakens bones and increases the risk of fractures.
Women with normal ovarian function ages 18 to 55 and postmenopausal women 60 years of age or older may be eligible for this study. Candidates will be screened with a medical history, physical examination, blood tests and vaginal ultrasound examination. For the ultrasound study, a probe that emits sound waves is inserted into the vagina, and the sound waves are converted to form images of the ovaries. The procedure is done with an empty bladder and takes about 10 minutes. After this screening visit (Visit 1), those enrolled in the study will return to the NIH Clinical Center for the following additional procedures:
Visit 2-Will be scheduled between days 3 and 5 of the menstrual cycle (for women who are still menstruating). Participants will have blood tests to measure hormone levels and to check for pregnancy, and will have another transvaginal ultrasound examination. They will then receive an injection of a synthetic form of follicle stimulating hormone (FSH), a hormone the body makes normally.
Visits 3 and 4-Will be scheduled 24 and 36 hours after the FSH injection given during Visit 2 for collection of blood samples.
Visit 5-Will be scheduled 48 hours after the FSH injection for additional blood sampling and a final transvaginal ultrasound examination.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
-
-
Maryland
-
Bethesda, Maryland, États-Unis, 20892
- National Institutes of Health Clinical Center, 9000 Rockville Pike
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
- INCLUSION CRITERIA:
A. Women with normal ovarian function:
Age 18 to 55.
Normal body mass index (18-30 kg/m(2)).
Normal menstrual cycles (between 25-35 days in length).
Ovulatory serum progesterone concentrations (in excess of 6 ng/mL in the menstrual cycle just preceding the study cycle).
B. Postmenopausal women (to serve as negative controls):
Greater than or equal to 60 years of age.
Proven fertility (as evidenced by a history of pregnancy regardless of outcome).
Normal body mass index (18-30 kg/m(2)).
Naturally menopausal: amenorrhea for at least one year; serum FSH greater than 40 IU/mL.
C. Women carriers of FMR1 premutations:
Age 18 to 40.
50 to 200 CGG repeats.
Normal menstrual cycles (between 25-35 days in length).
Have previously had genetic counseling regarding their FMR1 status.
EXCLUSION CRITERIA:
History of infertility or infertility in a first degree relative.
Acute or chronic disease.
Menopause due to surgery, radiation, or chemotherapy.
Current use of oral contraceptives or hormone replacement therapy, or use of these agents within the previous 3 months.
Use within the previous three months of any medication known to affect the hypothalamic-pituitary-ovarian axis (including over-the-counter and alternative medicines).
History of excessive exercise (greater than 10 hours a week).
Girls will be excluded because there are no data regarding FSH use in children.
Smokers.
Pregnant.
Breast feeding.
Persistent ovarian masses.
History of tumors of the ovary, breast, uterus, hypothalamus, or pituitary.
History of breast or endometrial cancer.
History of hypersensitivity to recombinant FSH or any one of its excipients.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Diagnostique
- Répartition: Non randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
---|---|
Expérimental: Control
Control for FSH stimulation test
|
No injection of FSH
|
Expérimental: Drug: FSH
FSH Stimulation Test
|
FSH Stimulation Test
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Délai |
---|---|
Follicle Stimulating Hormone Stimulated Serum Inhibin B Levels.
Délai: 24 hours
|
24 hours
|
Mesures de résultats secondaires
Mesure des résultats |
Délai |
---|---|
Follicle Stimulating Hormone Stimulated Serum Estradiol (E2) Levels
Délai: 24 hours
|
24 hours
|
Collaborateurs et enquêteurs
Publications et liens utiles
Publications générales
- Coulam CB, Adamson SC, Annegers JF. Incidence of premature ovarian failure. Obstet Gynecol. 1986 Apr;67(4):604-6.
- Anasti JN, Kalantaridou SN, Kimzey LM, Defensor RA, Nelson LM. Bone loss in young women with karyotypically normal spontaneous premature ovarian failure. Obstet Gynecol. 1998 Jan;91(1):12-5. doi: 10.1016/s0029-7844(97)00583-8.
- Faddy MJ, Gosden RG. A model conforming the decline in follicle numbers to the age of menopause in women. Hum Reprod. 1996 Jul;11(7):1484-6. doi: 10.1093/oxfordjournals.humrep.a019422.
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 000189
- 00-CH-0189
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .
Essais cliniques sur En bonne santé
-
AstraZenecaParexelComplété
Essais cliniques sur Control
-
Florida State UniversityMilitary Suicide Research ConsortiumComplétéIdéation suicidaire | Suicide, Tentative | Suicide et automutilation | Automutilation non suicidaireÉtats-Unis
-
Massachusetts General HospitalHarvard University; American Academy of Child Adolescent Psychiatry.InconnueColère | AgressionÉtats-Unis
-
Rethink Medical SLRecrutementQualité de vie | Complication liée au cathéter | Infection des voies urinaires associée au cathéterEspagne
-
Rethink Medical SLRetiréRétention urinaire | Complications du cathéter | Infection des voies urinaires associée au cathéterEspagne
-
King's College Hospital NHS TrustSt George's, University of LondonActif, ne recrute pasHernie diaphragmatique congénitaleRoyaume-Uni
-
Johnson & Johnson Vision Care, Inc.ComplétéCorrection de l'erreur de réfraction | Atténuation de la lumière viveÉtats-Unis
-
University of Southern CaliforniaPendulum TherapeuticsRetiréDiabète de type 2 | Symptômes gastro-intestinauxÉtats-Unis
-
University of Castilla-La ManchaComplétéDouleur au point gâchette, myofascialeEspagne
-
Icahn School of Medicine at Mount SinaiRecrutement
-
University of Castilla-La ManchaComplétéDouleur au point gâchette, myofascialeEspagne