Ovarian Hyperstimulation Syndrome Clinical Trial
Official title:
An Uncontrolled, Open-label Feasibility Study to Demonstrate That a GnRH Agonist (Decapeptyl) Can be Safely Administered to Trigger Final Oocyte Maturation in High Responder Patients to Mitigate the Risk of OHSS
Verified date | August 2015 |
Source | Elisha Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | Israel: Ministry of Health |
Study type | Interventional |
Ovarian hyperstimulation syndrome (OHSS) is a major complication of ovarian stimulation for IVF if hCG is used to trigger final oocyte maturation. The investigators propose that using GnRH agonist as a trigger will eliminate OHSS, even in high-risk patients.
Status | Terminated |
Enrollment | 6 |
Est. completion date | January 2014 |
Est. primary completion date | January 2014 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 42 Years |
Eligibility |
Inclusion Criteria: - A female patient who needs IVF to become pregnant. - Regular menstrual cycle. - Antral follicular count (AFC) > 18 - Following treatment with follitropin beta more than 18 follicles = 11 mm will develop. Exclusion Criteria: - Hypersensitivity to the active substance or to any of the medications used. - Tumors of the ovary, breast, uterus, pituitary or hypothalamus. - Pregnancy. - Abnormal (not menstrual) vaginal bleeding without a known/diagnosed cause. - Primary ovarian failure. - Ovarian cysts or enlarged ovaries. - A history of Ovarian Hyperstimulation Syndrome (OHSS). - A previous COS cycle that resulted in more than 30 follicles > 11 mm measured by ultrasound examination. - Fibroid tumours of the uterus incompatible with pregnancy. - Malformations of the reproductive organs incompatible with pregnancy |
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
Israel | IVF Unit, Elisha Hospital | Haifa |
Lead Sponsor | Collaborator |
---|---|
Elisha Hospital | Merck Sharp & Dohme Corp. |
Israel,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of Participants with Adverse Events as a Measure of Safety: The adverse event is the development of OHSS following oocyte retrieval. | OHSS usually occurs a few days following oocyte retrieval, and is not a threat once menses start. | 12 day from GnRH agonist trigger day. | Yes |
Secondary | Ongoing pregnancies following FTET cycles of cryopreserved embryos obtained following one treatment cycle of follitropin beta. | One month from embryo transfer date | No |
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