Single Follicular Dexarelix, a New Long Acting GnRH- Antagonist for LH Suppression During Ovarian Stimulation in Oocyte Donors. A Randomised Control Trial.
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Infertility
- Sponsor
- Assisting Nature
- Enrollment
- 180
- Locations
- 1
- Primary Endpoint
- Live birth rate according to stimulation protocol
- Last Updated
- 5 years ago
Overview
Brief Summary
A randomized prospective study in the evaluation of the long acting GnRH antagonist Degarelix against the classical multidose regime with Ganirelix for LH suppression during the follicular phase of an ovarian stimulation cycle in oocyte donors.
Detailed Description
A randomized prospective study of the use of single dose of the long acting GnRH antagonist Degarelix for ovarian stimulation cycle in oocyte donors: Ovarian stimulation started on cycle Day2 with gonadotropins 175-300 IU and either GnRH antagonist single dose Degarelix or multidose GnRH antagonist Ganirelix initiated on Day6 of the stimulation cycle. Agonist triggering was used in both groups for oocyte maturation. Blastocyst formation rate and Live Birth Rates were estimated for both groups.
Investigators
Papanikolaou Evaggelos
Papanikolaou Evaggelos, MD, PhD, Fertility Specialist, Scientific Director at Assisting Nature IVF Clinic
Assisting Nature
Eligibility Criteria
Inclusion Criteria
- •age 20-34 years;
- •body mass index (BMI) 18-29kg/m2;
- •regular menstrual cycle of 26-35 days,
- •AMH levels age appropriate (≥2.3 ng/ml)
- •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 hereditary genetic diseases;
- •women with heart disease, QT prolongation,heart failure
- •elevated liver enzymes, liver failure, hepatitis
- •women with inflammatory or autoimmune disease
- •abnormal karyotype;
- •endometriosis stage III/IV;
- •history of recurrent miscarriage;
- •severe OHSS in a previous stimulation cycle or any contraindication for the use of gonadotrophins.
Outcomes
Primary Outcomes
Live birth rate according to stimulation protocol
Time Frame: Up to 38 weeks after embryo transfer
Live birth rate according to stimulation protocol
Secondary Outcomes
- Blastulation rate according to stimulation protocol(Up to 6 days post oocyte retrieval)