Infertility
Conditions
Keywords
recombinant hCG, urinary hCG
Brief summary
The purpose of this study is to compare the clinical outcomes of recombinant human chorionic gonadotrophin (rHCG) and urinary HCG (uHCG) in patients undergoing IVF cycles.
Detailed description
Urinary human chorionic gonadotrophin (u-hCG) has been widely used to induce final oocyte maturation and to trigger ovulation in assisted conception. Recombinant technology has allowed the production of r-hCG inj which all urinary contaminants are absent. Hence, this would allow the safe subcutaneous administration of a compound with less batch-to-batch variation. This study will investigate the effectiveness of the recombinant hCG compared to the currently used urinary hCG.
Interventions
DRUGrHCG 250ug
Injection of 250 ug Ovitrelle to trigger final oocyte maturation
DRUGuHCG 5000 IU
Injection of 5000 IU Pregnyl to trigger final oocyte maturation
DRUGuHCG 7500 IU
Injection of 7500 IU Pregnyl to trigger final oocyte maturation
Sponsors
Eugonia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 39 Years
Healthy volunteers
Yes
Inclusion criteria
* At least 14 follicles \>11mm on the day of triggering final oocyte maturation * Pretreated with GnRH antagonist protocol
Exclusion criteria
* Poor responders * Women with 25 or more follicles on the day of trigger
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of mature oocytes | Day of oocyte retrieval (Day 0) | Percentage MII/COCs |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinical pregnancy per embryo transfer | 7 weeks of gestation | — |
| Ongoing pregnancy per embryo transfer | 12 weeks of gestation | — |
| Level of serum hCG on day of oocyte retrieval | Day of oocyte retrieval | — |
| Positive test per embryo transfer | 15 days post oocyte retrieval | — |
| Number of mature oocytes (MII) | Day of oocyte retrieval | — |
| Oocyte retrieval rate | Day of oocyte retrieval (Day 0) | Number of oocytes retrieved/number of follicles on the day of triggering final oocyte maturation |
| Incidence of severe early OHSS | up to Day 5 post oocyte retrieval | — |
| Number of oocytes (COC) retrieved | Day of oocyte retrieval | — |
Countries
Greece
Outcome results
None listed