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.

Pregnancy Rate Clinical Trial

Official 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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02809989
• Other study ID #: XM17-WH-40103
• Status: Completed
• Start date: March 31, 2016
• Est. completion date: March 13, 2018

Study information

• Verified date: November 2021
• Source: Teva Branded Pharmaceutical Products R&D, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 507
• Est. completion date: March 13, 2018
• Est. primary completion date: July 21, 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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).

Related Conditions & MeSH terms

• Oocytes
• Pregnancy Rate

Intervention

Drug:
• Ovaleap®
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).

Locations

Country	Name	City	State
Germany	Teva Investigational Site 034	Aalen	Baden-Württemberg
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	Teva Investigational Site 031	Berlin
Germany	Teva Investigational Site 022	Bielefeld
Germany	Teva Investigational Site 013	Dortmund
Germany	Teva Investigational Site 003	Düsseldorf
Germany	Teva Investigational Site 010	Düsseldorf
Germany	Teva Investigational Site 011	Essen
Germany	Teva Investigational Site 025	Esslingen
Germany	Teva Investigational Site 012	Großhansdorf
Germany	Teva Investigational Site 037	Hamburg
Germany	Teva Investigational Site 016	Hannover
Germany	Teva Investigational Site 028	Hildesheim
Germany	Teva Investigational Site 033	Kempten	Bayern
Germany	Teva Investigational Site 021	Kiel
Germany	Teva Investigational Site 029	Leipzig
Germany	Teva Investigational Site 020	Lübeck
Germany	Teva Investigational Site 014	Ludwigsburg
Germany	Teva Investigational Site 035	Ludwigshafen	Rheinland-Pfalz
Germany	Teva Investigational Site 023	Magdeburg
Germany	Teva Investigational Site 026	Munchen	Bayern
Germany	Teva Investigational Site 006	München
Germany	Teva Investigational Site 030	München
Germany	Teva Investigational Site 018	Münster
Germany	Teva Investigational Site 009	Osnabrück
Germany	Teva Investigational Site 007	Regensburg
Germany	Teva Investigational Site 032	Regensburg	Bayern
Germany	Teva Investigational Site 002	Rostock
Germany	Teva Investigational Site 008	Saarbrücken
Germany	Teva Investigational Site 019	Stuttgart
Germany	Teva Investigational Site 005	Ulm
Germany	Teva Investigational Site 024	Ulm
Germany	Teva Investigational Site 001	Wiesbaden

Sponsors (1)

Lead Sponsor	Collaborator
Teva Pharma GmbH

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of retrieved oocytes after ovarian stimulation therapy		12 months
Primary	Clinical pregnancy rate		12 months
Secondary	Number of days with administration of Ovaleap®		12 months
Secondary	Administered total dose of Ovaleap®		12 months
Secondary	Level of serum estradiol at the time of the last examination prior to induction of ovulation		12 months
Secondary	Endometrial thickness (mm) at time of the last sonography prior to induction of ovulation		12 months
Secondary	Used drugs for induction of the ovulation (recombinant Human chorionic gonadotropin (HCG), urinary HCG, GnRH agonist)		12 months
Secondary	Number of Metaphase II (MII)-oocytes		12 months
Secondary	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
Secondary	Day of embryo transfer (relative to the day of follicle puncture) and number of transferred embryos		12 months
Secondary	Luteal phase support (LPS): product, dose and duration of administration		12 months
Secondary	User satisfaction with the Ovaleap®-pen	Patient Questionnaire completed by patient	12 months
Secondary	"Baby-Take-Home-Rate" (live-births).		12 months
Secondary	Rate of multiple pregnancies (twins, triplets, quadruplets).		12 months
Secondary	Frequency and intensity of adverse drug reactions (ADRs)		12 months