Infertility, Female
Conditions
Keywords
IVF, infertility, long antagonist, long acting gonadotropin, corifollitropin alfa, ovarian stimulation
Brief summary
This is a prospective randomised study of the evaluation of the clinical IVF results after following a new revolutionary 3-Injection- Protocol for controlled ovarian stimulation in infertile women.
Detailed description
A randomized prospective study focusing on infertile women undergoing ovarian stimulation for IVF, using Elonva (corifollitropin alfa) as part of two different stimulation protocols. Women assigned to Protocol A receive a bolus late luteal dose of Degarelix, a new long acting GnRH antagonist, a sole Elonva injection in the evening of day 3 of the cycle, followed by the administration of a single dose of triggering agent (GnRH agonist or hCG a, according to the individual response). Women assigned to Protocol B are administered a single dose of Elonva (corifollitropin alfa) on day 2 of the cycle, followed by daily GnRH antagonist doses, fixed on day 7 of the cycle. Ovulation triggering is the same as in group A, with either GnRH agonist or hCG a, accordingly. Live Birth Rates are estimated for both groups of patients. The number of the formed blastocysts in each group is measured, as well.
Interventions
DIAGNOSTIC_TESTLive birth rate
Live Birth Rate and Blastulation Rate according to the protocol of COS
Sponsors
Assisting Nature
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
22 Years to 39 Years
Healthy volunteers
Yes
Inclusion criteria
* primary infertility * age 22-39 years; * body mass index (BMI) 18-29kg/m2; * regular menstrual cycle of 26-35 days, * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Live birth rate according to stimulation protocol | Up to 38 weeks after embryo transfer | Live birth rate according to stimulation protocol |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Blastulation rate according to stimulation protocol | Up to 6 days post oocyte retrieval | Blastulation rate according to stimulation protocol |
Countries
Greece
Contacts
Primary ContactEvaggelos Papanikolaou, MD,PhD
Outcome results
None listed