Skip to main content
OpenTrials
Completed

NCT Number: NCT02809989

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.

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Pregnancy Rate Oocytes

Age range

18 year–40 year

Sex eligibility

Female

Study type

Observational

Primary location

Teva Investigational Site 034, Aalen, Baden-Wurttemberg, Germany

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

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).

Primary outcomes

  1. Number of retrieved oocytes after ovarian stimulation therapy

    Time frame: 12 months

  2. Clinical pregnancy rate

    Time frame: 12 months

Secondary outcomes

  1. Number of days with administration of Ovaleap®

    Time frame: 12 months

  2. Administered total dose of Ovaleap®

    Time frame: 12 months

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

    Time frame: 12 months

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

    Time frame: 12 months

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

    Time frame: 12 months

  6. Number of Metaphase II (MII)-oocytes

    Time frame: 12 months

  7. Percentage fertilisation rate

    Time frame: 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.

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

    Time frame: 12 months

  9. Luteal phase support (LPS): product, dose and duration of administration

    Time frame: 12 months

  10. User satisfaction with the Ovaleap®-pen

    Time frame: 12 months

    Patient Questionnaire completed by patient

  11. "Baby-Take-Home-Rate" (live-births).

    Time frame: 12 months

  12. Rate of multiple pregnancies (twins, triplets, quadruplets).

    Time frame: 12 months

  13. Frequency and intensity of adverse drug reactions (ADRs)

    Time frame: 12 months

Sponsors and collaborators

Lead sponsor

Teva Pharma GmbH

Industry

Registry information

Official study title

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.

Important dates

Study start
2016
Primary completion
2017
Study completion
2018
First posted
Jun 22, 2016
Registry last updated
Nov 9, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.