Clinical Trials Logo

Clinical Trial Summary

The current study will compare hormone levels of AMH, FSH and inhibin B in blood specimens collected by venipuncture and fingerstick in a sample of pre-menopausal women ages 18-45 years with normal menstrual cycles.


Clinical Trial Description

Recent advances in cancer diagnosis and treatment have led to greater survival rates in patients with malignancies. However, these life-saving treatments, especially alkylating agents, often lead to premature ovarian failure, infertility and related long-term health problems. It is difficult to predict whether, and the extent to which, patients will experience these problems. There are no early clinical signs of decreased fertility potential; even young women who maintain cyclic menses after therapy are at high risk of infertility, early menopause and related health problems. Preliminary studies suggest that several surrogate measures of fertility potential are different in cancer survivors compared with controls. These include follicle stimulating hormone (FSH), estradiol, anti-mullerian hormone (AMH) and inhibin B. Large longitudinal studies are needed to validate these measures with gold standard outcomes such as pregnancy rates, pregnancy outcomes and time to menopause. The main impediment to assessing the value of these markers and generating data that is useful to cancer survivors is the need for frequent and timed blood samples.

Daily or frequent trips to the clinical center are not practical and reduce the compliance of even the most motivated patients. The hypothesis that will be tested by this study is that blood spot assays can be developed that provide robust, personalized data for surrogate markers of reproductive function which can be used to assess reproductive potential in women; furthermore, bloodspots collected at home are an acceptable method for reproductive hormone measurement in women with and without a history of cancer. The current study will compare hormone levels of AMH, FSH and inhibin B in blood specimens collected by venipuncture and fingerstick in a sample of subjects. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03840824
Study type Observational
Source University of Pennsylvania
Contact
Status Completed
Phase
Start date October 2010
Completion date August 2016

See also
  Status Clinical Trial Phase
Unknown status NCT01853501 - Effects of ADSC Therapy in Women With POF Phase 4
Completed NCT00417066 - Flexible GnRH Antagonist vs Flare up GnRH Agonist Protocol in Poor Responders Phase 4
Active, not recruiting NCT04675970 - Long Term Follow up Patients With Premature Ovarian Failure ex Vivo Gene Therapy
Recruiting NCT03480412 - Second Step Protocol in Poor Ovarian Responder (POR)
Completed NCT02644447 - Transplantation of HUC-MSCs With Injectable Collagen Scaffold for POF Phase 1/Phase 2
Recruiting NCT00119925 - 'SPRING'-Study: "Subfertility Guidelines: Patient Related Implementation in the Netherlands Among Gynaecologists" N/A
Recruiting NCT06117982 - The Impact of Granulocyte Colony Stimulating Factor on Premature Ovarian Insufficiency Phase 2
Suspended NCT03816852 - The Safety and Efficiency Study of Mesenchymal Stem Cell (19#iSCLife®-POI) in Premature Ovarian Insufficiency Phase 2
Not yet recruiting NCT04390308 - Is There A Role For Mechanical Stimulation In Ovarian Follicular Activation?
Completed NCT02783937 - Filgrastim for Premature Ovarian Insufficiency Phase 4
Completed NCT00295087 - X-Chromosome Inactivation Status and Premature Ovarian Failure N/A
Completed NCT00429494 - GnRH Analogue for Ovarian Function Preservation in Hematopoietic Stem Cell Transplantation Patients Phase 2
Not yet recruiting NCT05522634 - A Clinical Study of Chinese Herbal Compound TJAOA101 in the Treatment of Premature Ovarian Insufficiency Early Phase 1
Recruiting NCT05838157 - The Effect of HPV Vaccine on Menstrual Cycle in Women of Reproductive Age
Withdrawn NCT01129947 - The Use of DHEA in Women With Premature Ovarian Failure Phase 0
Completed NCT00001275 - Ovarian Follicle Function in Patients With Primary Ovarian Failure N/A
Not yet recruiting NCT04306185 - Ovarian Fragmentation Study (Crespo Medical Team) N/A
Recruiting NCT02062931 - Autologous Mesenchymal Stem Cells Transplantation In Women With Premature Ovarian Failure Phase 1/Phase 2
Completed NCT02151890 - Pregnancy After Stem Cell Transplantation in Premature Ovarian Failure Phase 1/Phase 2
Completed NCT02372474 - "It is a Real" The First Baby Of Autologous Stem Cell Therapy in Premature Ovarian Failure Phase 1/Phase 2