A Study of the Efficacy and Safety of Highly Purified Menotrophin Versus Recombinant Follitropin Alfa
Information source: Ferring Pharmaceuticals
Information obtained from ClinicalTrials.gov on February 12, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Infertility
Intervention: Menotrophin (Drug); Recombinant FSH (Follitropin alfa) (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: Ferring Pharmaceuticals Official(s) and/or principal investigator(s):
Dr. Rebecca Elwin, Study Director, Affiliation: Ferring UK
Overall contact:
Dr. Rebecca Elwin, Phone: 01753 214843, Email: rebecca.elwin@Ferring.Com
Summary
Prospective open label, randomised, parallel group, comparative pilot.
Clinical Details
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
Study design: Treatment, Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety/Efficacy Study
Primary outcome: Ongoing pregnancy rate, defined as positive fetal heart action ≥ 9 weeks after the first positive pregnancy test.
Detailed description:
Ongoing pregnancy rate, defined as positive fetal heart action 9 weeks after the first
positive pregnancy test. Number/diameter of follicles, number of oocytes retrieved, number of
pronuclear oocytes (referred to as zygotes or pre-embryos in the UK, quality of pronuclear
stage oocytes, number of embryos transferred, quality of embryos, number of frozen embryos,
endometrial thickness and morphology on day of HCG administration, estradiol levels at day of
HCG administration, implantation rate, number of days stimulated with gonadotrophins and
number of ampoules used, clinical pregnancy rate at 6 weeks after the first positive
pregnancy test, pregnancy outcome
Eligibility
Minimum age: 20 Years.
Maximum age: 35 Years.
Gender(s): Female.
Criteria:
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 IVF (or other 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 ³20 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 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.
Locations and Contacts
Dr. Rebecca Elwin, Phone: 01753 214843, Email: rebecca.elwin@Ferring.Com
Universitats-Frauenklinik Heidelberg Abt. Gynakologische Endokrinologie und Fertilitatsstorungen, Heidelberg 69115, Germany; Recruiting
Thomas Strowitzki, MD
Gemeinschaftspraxis und Tagesklinik, Hildesheim 1134, Germany; Recruiting
Georg Wilke, MD
Gemeinschaftspraxis und Tagesklinik, Dortmund 44135, Germany; Recruiting
Stefan Dieterle, MD
Leeds General Infirmary, Leeds, United Kingdom; Recruiting
Anthony Rutherford, M.D.
The Royal Hallamshire Hospital, Sheffield, United Kingdom; Recruiting
William Ledger, MD
Additional Information
Starting date: September 2005
Ending date: December 2008
Last updated: August 1, 2008
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