Infertility
Conditions
Keywords
ovarian hyper stimulation syndrome (OHSS), metaphase II oocytes (MII), good quality embryo's, implantation, pregnancy
Brief summary
The purpose of this study is to see whether patients triggered with only human Chorion Gonadotropin (hCG) have higher number of Metaphase II oocytes (MII) and implantation rate than patients triggered with hCG combined with Gonadotropin Releasing Hormone (GnRH) agonist.
Interventions
DRUGDecapeptyl Daily
Decapeptyl 0.2 mg SC once 1day
DRUGpregnyl
5000 IU SC
Sponsors
Onze Lieve Vrouw Hospital
AZ Jan Palfijn Gent
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
No minimum to 38 Years
Healthy volunteers
No
Inclusion criteria
* Intra-cytoplasmic sperm injection (ICSI) patients below 38 years * 1,2 or 3 rd IVF-cycle
Exclusion criteria
* polycystic ovary syndrome (PCOS) patients * patients with endocrinological diseases or problems
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| MII Oocytes | 3 weeks | the number of mature oocytes retrieved |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pregnancy Rate | 12 weeks | the number of pregnancies obtained, wich still is the most important issue for the patients |
| Patients With Cryopreserved Embryos | 4 weeks | — |
Countries
Belgium
Participant flow
Pre-assignment details
the Principal Investigator (PI) prescreened the patients and only the eligible patients were assigned to a group by the study coordinator
Participants by arm
| Arm | Count |
|---|---|
| HCG TRIGGERING TRIGGERING FOR FINAL MATURATION BY 5000 IU PREGNYL SC ONLY 36 HOURS BEFORE OOCYTE RETRIEVAL | 59 |
| hCG and GnRH Agonist Triggering DUAL TRIGGERING FOR FINAL MATURATION BY 5000IU PREGNYL SC AND DECAPEPTYL(GONAPEPTYL) 0.2 MG SC 36 HOURS BEFORE OOCYTE RETRIEVAL | 61 |
| Total | 120 |
Baseline characteristics
| Characteristic | HCG TRIGGERING | hCG and GnRH Agonist Triggering | Total |
|---|---|---|---|
| Age, Continuous | 30.5 YEARS STANDARD_DEVIATION 4.1 | 30.0 YEARS STANDARD_DEVIATION 3.6 | 30.2 YEARS STANDARD_DEVIATION 3.8 |
| Body Mass Index | 23.5 kg/m^2 STANDARD_DEVIATION 5.1 | 23.8 kg/m^2 STANDARD_DEVIATION 4.6 | 23.7 kg/m^2 STANDARD_DEVIATION 4.8 |
| Region of Enrollment Belgium | 59 participants | 61 participants | 120 participants |
| Sex: Female, Male Female | 59 Participants | 61 Participants | 120 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 59 | 0 / 61 |
| serious Total, serious adverse events | 0 / 59 | 0 / 61 |
Outcome results
Primary
MII Oocytes
the number of mature oocytes retrieved
Time frame: 3 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| hCG TRIGGERING | MII Oocytes | 9.2 cumulus oocyte complex | Standard Deviation 6.7 |
| hCG and GnRH Agonist Triggering | MII Oocytes | 10.3 cumulus oocyte complex | Standard Deviation 6.8 |
Secondary
Patients With Cryopreserved Embryos
Time frame: 4 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| hCG TRIGGERING | Patients With Cryopreserved Embryos | 21 patients with cryopreserved embryos |
| hCG and GnRH Agonist Triggering | Patients With Cryopreserved Embryos | 33 patients with cryopreserved embryos |
p-value: 0.04Fisher Exact
Secondary
Pregnancy Rate
the number of pregnancies obtained, wich still is the most important issue for the patients
Time frame: 12 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| hCG TRIGGERING | Pregnancy Rate | 28 pregnancies |
| hCG and GnRH Agonist Triggering | Pregnancy Rate | 45 pregnancies |