Infertility
Conditions
Keywords
GnRH Agonist, GnRH Antagonist, OHSS
Brief summary
The purpose of this study is to evaluate the appropriate controlled ovarian hyperstimulation (COH) protocol in good prognosis patients undergoing IVF treatment. The stimulation characteristics of cycles which include ultrashort flare GnRH agonist combined with flexible multidose GnRH antagonist will be compared to the flexible multidose GnRH antagonist protocol. The investigators hypothesized that combining the stimulatory effect of GnRH agonists and immediate suppression of the GnRH antagonist in a unique protocol may be a valuable new COH strategy for IVF patients, resulting in improved ART outcome.
Detailed description
The ultrashort flare GnRH agonist combined with flexible multidose GnRH antagonist protocol during COH cycle resulted in a significantly higher clinical pregnancy rate in patients with poor embryo quality, with repeated IVF failures and in poor responders. This protocol combines the effect of the microdose flare on endogenous follicle stimulating hormone (FSH) release with the benefit of an immediate luteinizing hormone suppression of the GnRH antagonist. The basic hypothesis of this approach can also benefit IVF patients with good prognosis without compromising the ability to use gonadotrophin-releasing hormone (GnRH) agonist to effectively trigger ovulation, while completely eliminating any threat of clinically significant ovarian hyperstimulation syndrome (OHSS). The purpose of the study is to compare cycles consisting of ultrashort flare GnRH agonist combined with flexible multidose GnRH antagonist with those using the flexible multidose GnRH antagonist protocol 1\. To compare the IVF outcome variables and ongoing pregnancy rates.
Interventions
OTHERARM A- Agonist/Antagonist protocol
In vitro fertilization (IVF/ICSI)
OTHERARM B- Antagonist protocol
In vitro fertilization (IVF/ICSI)
Sponsors
Sheba Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
20 Years to 35 Years
Healthy volunteers
Yes
Inclusion criteria
* Up to three previous IVF attempts
Exclusion criteria
* Patients with poor or no response in previous COH for IVF cycles * Abnormal ovarian reserve test i.e. anti-mullerian hormone (AMH), Antral follicle test * Risk factor for Diminished Ovarian Reserve
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Ongoing pregnancy rates | 2 years |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Total gonadotropin use | 2 Years | — |
| Biochemical pregnancy | 2 Years | Positive pregnancy test without documentation of intrauterine or extrauterine pregnancy |
| Clinical pregnancy | 2 Years | Positive pregnancy test with documentation of intrauterine or extrauterine pregnancy |
| Multiple pregnancy rate | 2 Years | — |
| Fertilization rate | 2 Years | — |
| Number of oocytes | 2 years | — |
| OHSS rates | 2 Years | — |
| Embryo quality | 2 Years | Grading of a day 3 embryo based on the number of cells that make up the embryo, the amount of fragmentation, and the symmetry of each of the embryo's cells (blastomeres). E.g. good quality embryos: embryos that reach the eight-cell stage with less than 20% fragmentation on day 3 |
| Miscarriage rate | 2 Years | — |
Other
| Measure | Time frame |
|---|---|
| Positive Pregnancy Test | 2 Years |
Countries
Israel
Outcome results
None listed