sub fertility MedDRA version: 7.1 Level: LLT Classification code 10042391
Conditions
Interventions
Product Name: Menopur®
Pharmaceutical Form: Powder and solvent for solution for injection
INN or Proposed INN: Menotrophin
CAS Number: 9002-68-0
Sponsors
Ferring Arzneimittel GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: The patients must meet all of the following inclusion criteria Signed informed consent; Subfertile premenopausal female patients eligible for IVF treatment; Aged more than or equal to 20 and less than or equal to 35 years; Body mass index of >18 and =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: The patient may not be entered into the study if any of the following exclusion criteria exist. Presence of any clinically relevant systemic disease (e.g. insulin-dependent diabetes mellitus); A history of or current endocrine disease, including polycystic ovary-like syndrome and hyperprolactinaemia; A history of coagulation disorders; Persistent ovarian cysts; Contraindications for the use of gonadotrophins or GnRH antagonists; A history of hypersensitivity to any of the constituents of the study medication or related compounds; Three or more previous cycles of IVF (or other ART); A history of alcohol abuse (more than 30 units per week on a regular basis); History of chemo- or radiotherapy; Currently breast-feeding, pregnant or with a contraindication to pregnancy; Diagnosed poor responders in prior IVF treatment; History of severe OHSS (4 or 5) in former IVF treatment; Investigational drug within the 30 days prior to treatment; Any other condition or history that the investigator considers might increase the risk to the individual.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is to compare highly purified Menotrophin with Follitropin alfa with respect to ongoing pregnancy (determined by positive fetal heart action at more than or equal to 9 weeks after the first positive pregnancy test) in the treatment of 60 subfertile females undergoing IVF using a GnRH antagonist protocol to supress endogenous FSH and LH. ;Primary end point(s): Ongoing pregnancy rate, defined as positive fetal heart action at more than or equal to 9 weeks after the first positive pregnancy test, after the IVF treatment cycle.;Secondary Objective: The secondary objective of this study is to compare the efficacy of highly purified Menotrophin with that of Follitropin alfa with respect to the secondary efficacy endpoints in the treatment of 60 subfertile females undergoing IVF using a GnRH antagonist protocol to supress endogenous FSH and LH. | — |
Countries
United Kingdom
Outcome results
None listed