Clinical and Live Birth Rates After Controlled Ovarian Stimulation With the Long Antagonist Protocol Versus Classical Antagonist Protocol
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 120
- Locations
- 1
- Primary Endpoint
- Clinical Pregnancy Rate according to stimulation protocol
Study Overview
Brief Summary
A randomized prospective study of the evaluation of the clinical IVF results after following Long Antagonist protocol for controlled ovarian stimulation versus following classical antagonist protocol
Detailed Description
A randomized prospective study of administration of Degarelix in late luteal phase of women undergoing ovarian stimulation for IVF: Single dose of Degarelix (24mg, 16mg or 12 mg), on day 24th of previous luteal face cycle, was administered. The Clinical Pregnancy and Live Birth Rates were estimated for this group of patients, comparing to the rates of the group which followed classical antagonist protocol. The number of the formed blastocysts in each group is measured, as well.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to 39 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
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.
Outcomes
Primary Outcomes
Clinical Pregnancy Rate according to stimulation protocol
Time Frame: 6 weeks to 42 weeks after embryo transfer
Clinical Pregnancy Rate according to stimulation protocol
Number of formed blastocysts
Time Frame: 5 days after the OPU day
The number of the formed blastocysts in each group
Secondary Outcomes
- Live Birth Rate according to stimulation protocol(6 weeks to 42 weeks after embryo transfer)
Investigators
Papanikolaou Evaggelos
Papanikolaou Evaggelos, MD, PhD
Assisting Nature