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 Pharmaceuticals

Status: Completed

Conditions: Oocytes; Pregnancy Rate

Treatments: Drug: Ovaleap®

Study type: Observational

Funder types: Industry

Identifiers

NCT02809989

XM17-WH-40103

Details and patient eligibility

About

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.

Enrollment: 507 patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: No Healthy Volunteers

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).

Trial design

507 participants in 1 patient group

Ovaleap®

Description:

Single group prospective treatment cohort

Treatment:

Drug: Ovaleap®