Controlled ovarian hyperstimulation to induce the development of multiple follicles for assisted reproductive technologies MedDRA version: 14.0 Level: PT Classification code 10021926 Term: Infertility System Organ Class: 10038604 - Reproductive system and breast disorders
Conditions
Interventions
Trade Name: Menogon® HP
Pharmaceutical Form: Powder and solvent for solution for injection
CAS Number: 9002-68-0
Other descriptive name: MENOTROPHIN
Concentration unit: IU international unit(s)
Concen
Sponsors
FERRING Arzneimittel GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Signed informed consent 2. Subfertile premenopausal female patients eligible for IVF treatment 3. Aged >=34 and 18 and 1ng/ml), prolactin, TSH) in early follicular phase within the clinically normal limits at Screening Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Presence of any clinically relevant systemic disease (eg, insulin-dependent diabetes mellitus) 2. A history of or current endocrine disease (excluding treated hypothyreosis), including polycystic ovary syndrome (PCOS) and hyperprolactinaemia 3. A history of coagulation disorders 4. Persistent ovarian cysts (>3 months) 5. Contraindications for the use of gonadotrophins or GnRH antagonists 6. A history of hypersensitivity to any of the constituents of the study medication or related compounds 7. A history of alcohol abuse (more than 30 units per week on a regular basis) 8. History of chemo- or radiotherapy 9. Currently breast-feeding, pregnant or with a contraindication to pregnancy 10. Diagnosed poor (<3 oocytes) responders to prior gonadotrophin stimulated ART-cycle 11. History of severe OHSS (grade 4 or 5) in former gonadotrophin stimulated ART-cycle 12. Investigational drug within the last 30 days prior to Visit 3 or former enrolment into this study 13. Any other condition or history that the Investigator considers might increase the risk to the individual 14. Incapability to understand the aim, importance and consequences of the study and to give legal informed consent 15. Institutionalization due to regulatory or judicial order 16. Possible dependence on the Sponsor or Investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To demonstrate that highly purified Menotrophin produces significant lower progesterone (P4) serum levels during the follicular phase in comparison to Follitropin alpha in the treatment of subfertile females undergoing IVF using a GnRH antagonist protocol for pituitary down-regulation.;Secondary Objective: to investigate • if the progesterone serum levels during the follicular phase might be a useful predictor for the success rate of the ongoing-pregnancy rates in the Menotrophin (HP-hMG) group and the Follitropin alpha group. • if highly purified Menotrophin is non-inferior or whether there are differences existing to Follitropin alpha in the treatment of subfertile females in an IVF programme with respect to efficacy and safety. ;Primary end point(s): Primary endpoint is the serum progesterone (P4) level in the morning of the day of hCG administration. | — |
Countries
Germany
Outcome results
None listed