Oocytes, Pregnancy Rate
Conditions
Brief summary
The aim of this non-interventional study is to extend the knowledge on effectiveness of Ovaleap® (number of oocytes and pregnancy rate) during routine IVF- or ICSI-treatment using a Gonadotropin-releasing hormone (GnRH) antagonist protocol in a large number of patients.
Interventions
DRUGOvaleap®
About 6-8 weeks of observation per patient from start of the stimulation therapy with Ovaleap® depending on the duration of the required stimulating therapy. Up to 10-11 months per patient for follow-up but only if in case of songraphically intact intrauterine pregnancy to determinate the Baby-Take-Home-Rate (live-births).
Sponsors
Teva Pharma GmbH
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
No
Inclusion criteria
* Women with a medical indication for an ovarian stimulation therapy for the purposes of an IVF or ICSI. * First-time ovarian stimulating therapy for an IVF or ICSI. * Ovarian stimulation therapy exclusively with Ovaleap®. * GnRH antagonist protocol. * Body-Mass-Index (BMI) \< 30 kg/m2. * Duration of menstrual cycle 24 - 35 days. * Additional criteria apply, please contact the investigator for more information
Exclusion criteria
* Combined application of IVF and ICSI * Ovarian hyperstimulation with Ovaleap® with a consecutive social freezing. * Polycystic ovary syndrome (PCOS). * Endometriosis (AFS (American Fertility Society) grade 3 and 4). * Uterine myoma (intramural \> 4 cm, submucosal). * Hydrosalpinx (on one side or both sides).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of retrieved oocytes after ovarian stimulation therapy | 12 months |
| Clinical pregnancy rate | 12 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Level of serum estradiol at the time of the last examination prior to induction of ovulation | 12 months | — |
| Endometrial thickness (mm) at time of the last sonography prior to induction of ovulation | 12 months | — |
| Used drugs for induction of the ovulation (recombinant Human chorionic gonadotropin (HCG), urinary HCG, GnRH agonist) | 12 months | — |
| Number of Metaphase II (MII)-oocytes | 12 months | — |
| Percentage fertilisation rate | 12 months | * IVF: number of fertilised oocytes in 2-pro nucleus (2-PN)-stage / number of inseminated MII-oocytes as a percentage. * ICSI: number of fertilised oocytes in 2-PN-stage / number of injected MII-oocytes as a percentage. |
| Number of days with administration of Ovaleap® | 12 months | — |
| Luteal phase support (LPS): product, dose and duration of administration | 12 months | — |
| User satisfaction with the Ovaleap®-pen | 12 months | Patient Questionnaire completed by patient |
| Baby-Take-Home-Rate (live-births). | 12 months | — |
| Rate of multiple pregnancies (twins, triplets, quadruplets). | 12 months | — |
| Frequency and intensity of adverse drug reactions (ADRs) | 12 months | — |
| Day of embryo transfer (relative to the day of follicle puncture) and number of transferred embryos | 12 months | — |
| Administered total dose of Ovaleap® | 12 months | — |
Countries
Germany
Outcome results
None listed