Infertility Clinical Trial
Official title:
A Prospective, Open Label, Randomised, Parallel Group, Comparative Pilot Study to Study the Efficacy and Safety of Highly Purified Menotrophin Versus Recombinant FSH (Follitropin Alfa) Administered Subcutaneously to Subfertile Female Patients Undergoing IVF Using Antagonist Downregulation
Prospective open label, randomised, parallel group, comparative pilot.
Status | Completed |
Enrollment | 80 |
Est. completion date | April 2009 |
Est. primary completion date | July 2008 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 20 Years to 35 Years |
Eligibility |
Female patients aged > or = 20 and < or = 35 years with a BMI of >18 and <32 kg/m2 who
have received no more than two previous cycles of in vitro fertilisation (IVF) or other
assisted reproductive technique (ART) and whose partners have normal sperm (according to
WHO 1999 criteria). Inclusion criteria: - Signed informed consent; - Subfertile premenopausal female patients eligible for IVF treatment; - Aged >=20 and <=35 years; - Body mass index of >18 and <32 kg/m2 - Normal endocrine assessment within the last 6 months; - Normal pelvic ultrasound (showing two ovaries, no ovarian abnormalities and normal uterus) within the last 6 months; - Receipt of no more than two previous cycles of IVF (or other ART); - At least 3 consecutive ovulatory menstrual cycles of 24-35 days, and documented evidence of ovulatory cycles within the previous 12 months; - No fertility-modifying treatment within the 3 months prior to this treatment cycle; - Infertility attributable to or in association with either tubal factor, or unexplained causes; - Sperm of partner classed as normal according to WHO 1999 criteria within the year prior to beginning therapy; - Negative serum beta-HCG pregnancy test prior to beginning therapy; - Clinically normal baseline haematology, clinical chemistry, and urinalysis parameter values, negative serum HBsAg and HIV antibody tests; - Screening endocrine test results (estradiol, LH, FSH, progesterone, prolactin, TSH) in early follicular phase within the normal limits for the clinical laboratory. Exclusion criteria - 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 ovarian hyperstimulation syndrome (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. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Germany | Gemeinschaftspraxis und Tagesklinik, Olpe 19 | Dortmund | |
Germany | Universitats-Frauenklinik Heidelberg Abt. Gynakologische Endokrinologie und Fertilitatsstorungen, Voßstr. 9 | Heidelberg | |
Germany | Gemeinschaftspraxis und Tagesklinik, Zingel 29 | Hildesheim | |
United Kingdom | Royal Infirmary of Edinburgh, 51 Little France | Edinburgh | |
United Kingdom | Leeds General Infirmary, Great George Street | Leeds | |
United Kingdom | The Royal Hallamshire Hospital, University of Sheffield, Jessop Wing, Tree Root Walk | Sheffield |
Lead Sponsor | Collaborator |
---|---|
Ferring Pharmaceuticals |
Germany, United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of Participants With an Ongoing Pregnancy | Approx week 13; 9 weeks or more after the 1st positive pregnancy test | No | |
Primary | Percentage of Participants With an Ongoing Pregnancy | Approx week 13; 9 weeks or more after the first positive pregnancy test | No | |
Secondary | Participants With Varying Numbers of Follicles That Were Greater Than or Equal to 17 Millimeters | Day 7 and, if appropriate, every 2 days thereafter (Days 9/11/13) | No | |
Secondary | Participants With Varying Numbers of Oocytes Retrieved | Approximately study day 15 | No | |
Secondary | Participants With Varying Numbers of Pronuclear Stage Oocytes | Approximately study day 15 | No | |
Secondary | Participants With Varying Numbers of Embryos Transferred | Approximately study day 17 | No | |
Secondary | Participants With Varying Numbers of Embryos Frozen | Approximately study day 17 | No | |
Secondary | Mean Number of Days Stimulated With Gonadotrophins | study days 1 - 13 | No | |
Secondary | Pregnancy Outcomes | Approximately 10 months | No | |
Secondary | Mean Endometrial Thickness | Day 7 or 9 or 11 or 13 | No | |
Secondary | Mean Estradiol Level | Day 7 or 9 or 11 or 13 | No |
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