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.

Teva Pharma GmbH507 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

507

Conditions

Pregnancy Rate Oocytes

Interventions

Ovaleap®DRUG

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).

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 40 Years

Medical Language ↔ Plain English

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).

Locations (37)

Outcomes

Primary Outcomes

Number of retrieved oocytes after ovarian stimulation therapy

Time frame: 12 months

Clinical pregnancy rate

Time frame: 12 months

Secondary Outcomes

Number of days with administration of Ovaleap®

Time frame: 12 months

Administered total dose of Ovaleap®

Time frame: 12 months

Level of serum estradiol at the time of the last examination prior to induction of ovulation

Time frame: 12 months

Endometrial thickness (mm) at time of the last sonography prior to induction of ovulation

Time frame: 12 months

Used drugs for induction of the ovulation (recombinant Human chorionic gonadotropin (HCG), urinary HCG, GnRH agonist)

Time frame: 12 months

Number of Metaphase II (MII)-oocytes

Time frame: 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.

Time frame: 12 months

Day of embryo transfer (relative to the day of follicle puncture) and number of transferred embryos

Time frame: 12 months

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.

Teva Investigational Site 034

Aalen, Baden-Wurttemberg, Germany

Teva Investigational Site 033

Kempten (Allgäu), Bavaria, Germany

Teva Investigational Site 026

München, Bavaria, Germany

Teva Investigational Site 032

Regensburg, Bavaria, Germany

Teva Investigational Site 035

Ludwigshafen am Rhein, Rhineland-Palatinate, Germany

Teva Investigational Site 036

Aalen, Germany

Teva Investigational Site 004

Berlin, Germany

Teva Investigational Site 015

Berlin, Germany

Teva Investigational Site 017

Berlin, Germany

Teva Investigational Site 027

Berlin, Germany

...and 27 more locations