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.

Completed

• Conditions: Pregnancy Rate; Oocytes
• Interventions: Drug: Ovaleap®

• Registration Number: NCT02809989
• Lead Sponsor: Teva Pharma GmbH

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-03-31
• Study First Submitted: 2016-06-20
• Study First Submitted QC: 2016-06-20
• Study First Posted: 2016-06-22
• Primary Completion: 2017-07-21
• Study Completion: 2018-03-13
• Status Verified: 2021-11
• Last Update Submitted: 2021-11-05
• Last Update Posted: 2021-11-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 507

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).

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Ovaleap®	Ovaleap®	Single group prospective treatment cohort

Primary Outcome Measures

Name	Time	Method
Number of retrieved oocytes after ovarian stimulation therapy	12 months
Clinical pregnancy rate	12 months

Secondary Outcome Measures

Name	Time	Method
Number of days with administration of Ovaleap®	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.
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
Frequency and intensity of adverse drug reactions (ADRs)	12 months
Rate of multiple pregnancies (twins, triplets, quadruplets).	12 months
Level of serum estradiol at the time of the last examination prior to induction of ovulation	12 months
"Baby-Take-Home-Rate" (live-births).	12 months
User satisfaction with the Ovaleap®-pen	12 months	Patient Questionnaire completed by patient
Administered total dose of Ovaleap®	12 months

Trial Locations

Locations (37)

Teva Investigational Site 034; 🇩🇪 Aalen, Baden-Württemberg, Germany

Teva Investigational Site 033; 🇩🇪 Kempten, Bayern, Germany

Teva Investigational Site 026; 🇩🇪 Munchen, Bayern, Germany

Teva Investigational Site 032; 🇩🇪 Regensburg, Bayern, Germany

Teva Investigational Site 035; 🇩🇪 Ludwigshafen, Rheinland-Pfalz, 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

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