Status:
COMPLETED
Progesterone Serum Levels in Subfertile Female Patients Undergoing in Vitro Fertilisation (IVF)
Lead Sponsor:
Ferring Pharmaceuticals
Collaborating Sponsors:
Ferring Arzneimittel GmbH
Conditions:
Infertility
Eligibility:
FEMALE
34-42 years
Phase:
PHASE4
Brief Summary
This study is aimed to demonstrate that highly purified Menotrophin produces significant lower progesterone serum levels during the follicular phase in comparison to Follitropin alpha in the treatment...
Eligibility Criteria
Inclusion
- Signed informed consent
- Subfertile premenopausal female patients eligible for in vitro fertilisation (IVF) treatment
- Aged ≥34 and ≤42 years
- Body mass index of \>18 and \<28 kg/m\^2
- Normal pelvic ultrasound at Screening
- No more than two previous gonadotrophin stimulated cycles of IVF or intracytoplasmic sperm injection (ICSI) in the history of infertility treatment (gonadotrophin stimulated cycles not used for IVF or ICSI do not count; Clomifen cycles are no exclusion criterion)
- At least 3 consecutive ovulatory menstrual cycles of 24-35 days
- No fertility stimulating drugs at all
- Sperm of partner classified as normal according to World Health Organisation (WHO) 2010 criteria
- Clinically normal baseline haematology, clinical chemistry, and urinalysis values
- Negative serum Hepatitis B Surface Antigen (HBsAg), Hepatitis C Virus (HCV) and Human Immunodeficiency Virus (HIV) antibody tests within the last 6 months prior to Screening
- Endocrine test results within the clinically normal limits at Screening
Exclusion
- Presence of any clinically relevant systemic disease (e.g., insulin-dependent diabetes mellitus)
- A history of or current endocrine disease (excluding treated hypothyreosis), including polycystic ovary syndrome (PCOS) and hyperprolactinaemia
- A history of coagulation disorders
- Persistent ovarian cysts (\>3 months)
- A history of hypersensitivity to any of the constituents of the study medication or related compounds
- Diagnosed poor (\<3 oocytes) responders to prior gonadotrophin stimulated ART-cycle
- History of severe ovarian hyperstimulation syndrome in former gonadotrophin stimulated assisted reproductive technology (ART)-cycle
Key Trial Info
Start Date :
October 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2013
Estimated Enrollment :
124 Patients enrolled
Trial Details
Trial ID
NCT01225835
Start Date
October 1 2010
End Date
June 1 2013
Last Update
March 14 2014
Active Locations (8)
Enter a location and click search to find clinical trials sorted by distance.
1
Fertility Center Berlin
Berlin, Germany
2
Praxisklinik Sydow am Gendarmenmarkt
Berlin, Germany
3
Kinderwunschzentrum Dortmund
Dortmund, Germany
4
Universitätsklinikum Duesseldorf, Frauenklinik
Düsseldorf, Germany