A Study to Evaluate the Effect of Ovaleap® on the Pregnancy Rate and Clinical Effects as Well as the User-friendliness of the Ovaleap®-Pen.

Study Overview
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Brief Summary
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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.

Official Title
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Multicentre, Prospective, Open, Non-interventional Study to Evaluate the Effect of Ovaleap® on the Pregnancy Rate and Clinical Effects as Well as the User-friendliness of the Ovaleap®-Pen in the Clinical Routine of the IVF- / ICSI-treatment.

Conditions
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Pregnancy Rate, Oocytes

Intervention / Treatment
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* Drug: Ovaleap®


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Ovaleap®<br>Single group prospective treatment cohort | Drug: Ovaleap®<br>* 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).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of retrieved oocytes after ovarian stimulation therapy |  | 12 months | 
| Clinical pregnancy rate |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of days with administration of Ovaleap® |  | 12 months | 
| Administered total dose of Ovaleap® |  | 12 months | 
| 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 | 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. | 12 months | 
| Day of embryo transfer (relative to the day of follicle puncture) and number of transferred embryos |  | 12 months | 
| Luteal phase support (LPS): product, dose and duration of administration |  | 12 months | 
| User satisfaction with the Ovaleap®-pen | Patient Questionnaire completed by patient | 12 months | 
| 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 |