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.

Study Type: Interventional

Study Design: Allocation: Randomized, Control: Active Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Study Primary Completion Date: July 2008

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.

Intervention(s) in this Clinical Trial

• Drug: Menotrophin
  • 150 IU Menotrophin daily subcutaneous injection for a maximum of 13 days. In the event of hyperstimulation, the dose was reduced to 75 IU daily.
• Drug: Follitropin alfa
  • 150 IU follitropin alfa daily by subcutaneous injection for a maximum of 13 days. In the event of hyperstimulation, the dose was reduced to 75 IU daily.

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: Menotrophin
• Active Comparator: Follitropin alfa

Primary Measures

• Number of Participants With an Ongoing Pregnancy
  • Time Frame: Approx week 13; 9 weeks or more after the 1st positive pregnancy test
    Safety Issue?: No
• Percentage of Participants With an Ongoing Pregnancy
  • Time Frame: Approx week 13; 9 weeks or more after the first positive pregnancy test
    Safety Issue?: No

Secondary Measures

• Participants With Varying Numbers of Follicles That Were Greater Than or Equal to 17 Millimeters
  • Time Frame: Day 7 and, if appropriate, every 2 days thereafter (Days 9/11/13)
    Safety Issue?: No
• Participants With Varying Numbers of Oocytes Retrieved
  • Time Frame: Approximately study day 15
    Safety Issue?: No
• Participants With Varying Numbers of Pronuclear Stage Oocytes
  • Time Frame: Approximately study day 15
    Safety Issue?: No
• Participants With Varying Numbers of Embryos Transferred
  • Time Frame: Approximately study day 17
    Safety Issue?: No
• Participants With Varying Numbers of Embryos Frozen
  • Time Frame: Approximately study day 17
    Safety Issue?: No
• Mean Number of Days Stimulated With Gonadotrophins
  • Time Frame: study days 1 - 13
    Safety Issue?: No
• Pregnancy Outcomes
  • Time Frame: Approximately 10 months
    Safety Issue?: No
• Mean Endometrial Thickness
  • Time Frame: Day 7 or 9 or 11 or 13
    Safety Issue?: No
• Mean Estradiol Level
  • Time Frame: Day 7 or 9 or 11 or 13
    Safety Issue?: No

• 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.

Gender Eligibility for this Clinical Trial: Female

Minimum Age for this Clinical Trial: 20 Years

Maximum Age for this Clinical Trial: 35 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers

Lead Sponsor: Ferring Pharmaceuticals

Overall Clinical Trial Officials and Contacts

Clinical Development Support Study Director Ferring Pharmaceuticals  

Information obtained from ClinicalTrials.gov on March 18, 2010

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00257556

Study ID Number: FE999906 CS004 (PROSPECT)

ClinicalTrials.gov Identifier: NCT00257556

Health Authority: United Kingdom: National Health Service