Pregnancy, Ovarian Clinical Trial
Official title:
Long Antagonist Protocol for IVF: a Proof of Concept for a Single Luteal GnRH- Antagonist Protocol
A prospective study of three different doses of Degarelix in late luteal phase of women undergoing ovarian stimulation for IVF
Status | Recruiting |
Enrollment | 120 |
Est. completion date | June 30, 2021 |
Est. primary completion date | June 30, 2021 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years to 39 Years |
Eligibility |
Inclusion Criteria: - primary infertility - age 18-39 years; body mass index (BMI) 18-29kg/m2; - regular menstrual cycle of 26-35days, - presumed to be ovulatory; - early follicular- phase serum concentration of FSH within normal limits (1-12 IU/l). Exclusion Criteria: - women with diabetes and other metabolic disease - women with heart disease, QT prolongation,heart failure - elevated liver enzymes, liver failure, hepatitis - women with inflammatory or autoimmune disease - abnormal karyotype; - polycystic ovarian syndrome, - endometriosis stage III/IV; - history of being a 'poor responder', - defined as >20 days of gonadotrophin in a previous stimulation cycle, or any previous cancellation of a stimulation cycle due to limited follicular response, or development of less than 4 follicles 15 mm in a previous stimulation cycle; history of recurrent miscarriage; severe OHSS in a previous stimula- tion cycle or any contraindication for the use of gonadotrophins. |
Country | Name | City | State |
---|---|---|---|
Greece | Assisting Nature | Thessaloníki |
Lead Sponsor | Collaborator |
---|---|
Assisting Nature |
Greece,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | LH levels | Effectively down regulation of follicular LH levels (<14mIU/ml)/ | 4 days after injection of Degarelix |
Status | Clinical Trial | Phase | |
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Recruiting |
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