A Study of the Efficacy and Safety of Highly Purified Menotrophin Versus Recombinant Follitropin Alfa

This study has been completed.
Sponsor:
Information provided by:
Ferring Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00257556
First received: November 22, 2005
Last updated: February 12, 2010
Last verified: February 2010
  Purpose

Prospective open label, randomised, parallel group, comparative pilot.


Condition Intervention Phase
Infertility
Drug: Menotrophin
Drug: Follitropin alfa
Phase 4

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

Resource links provided by NLM:


Further study details as provided by Ferring Pharmaceuticals:

Primary Outcome Measures:
  • Number of Participants With an Ongoing Pregnancy [ Time Frame: Approx week 13; 9 weeks or more after the 1st positive pregnancy test ] [ Designated as 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 ] [ Designated as safety issue: No ]

Secondary Outcome 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) ] [ Designated as safety issue: No ]
  • Participants With Varying Numbers of Oocytes Retrieved [ Time Frame: Approximately study day 15 ] [ Designated as safety issue: No ]
  • Participants With Varying Numbers of Pronuclear Stage Oocytes [ Time Frame: Approximately study day 15 ] [ Designated as safety issue: No ]
  • Participants With Varying Numbers of Embryos Transferred [ Time Frame: Approximately study day 17 ] [ Designated as safety issue: No ]
  • Participants With Varying Numbers of Embryos Frozen [ Time Frame: Approximately study day 17 ] [ Designated as safety issue: No ]
  • Mean Number of Days Stimulated With Gonadotrophins [ Time Frame: study days 1 - 13 ] [ Designated as safety issue: No ]
  • Pregnancy Outcomes [ Time Frame: Approximately 10 months ] [ Designated as safety issue: No ]
  • Mean Endometrial Thickness [ Time Frame: Day 7 or 9 or 11 or 13 ] [ Designated as safety issue: No ]
  • Mean Estradiol Level [ Time Frame: Day 7 or 9 or 11 or 13 ] [ Designated as safety issue: No ]

Enrollment: 80
Study Start Date: October 2005
Study Completion Date: April 2009
Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Menotrophin 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.
Other Names:
  • Menopur
  • hMG
  • highly purified menotrophin
Active Comparator: Follitropin alfa 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.
Other Names:
  • rFSH
  • recombinant FSH

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

Ages Eligible for Study:   20 Years to 35 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00257556

Locations
Germany
Gemeinschaftspraxis und Tagesklinik, Olpe 19
Dortmund, Germany, 44135
Universitats-Frauenklinik Heidelberg Abt. Gynakologische Endokrinologie und Fertilitatsstorungen, Voßstr. 9
Heidelberg, Germany, 69115
Gemeinschaftspraxis und Tagesklinik, Zingel 29
Hildesheim, Germany, 1134
United Kingdom
Royal Infirmary of Edinburgh, 51 Little France
Edinburgh, United Kingdom, EH16 4SA
Leeds General Infirmary, Great George Street
Leeds, United Kingdom, LS1 3EX
The Royal Hallamshire Hospital, University of Sheffield, Jessop Wing, Tree Root Walk
Sheffield, United Kingdom, S10 2SF
Sponsors and Collaborators
Ferring Pharmaceuticals
Investigators
Study Director: Clinical Development Support Ferring Pharmaceuticals
  More Information

No publications provided

Responsible Party: Clinical Development Support, Ferring Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00257556     History of Changes
Other Study ID Numbers: FE999906 CS004 (PROSPECT), 2004-001307-35
Study First Received: November 22, 2005
Results First Received: January 8, 2010
Last Updated: February 12, 2010
Health Authority: United Kingdom: National Health Service
Germany: Ethics Commission

Additional relevant MeSH terms:
Infertility
Genital Diseases, Male
Genital Diseases, Female
Menotropins
Follicle Stimulating Hormone
Fertility Agents, Female
Fertility Agents
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists

ClinicalTrials.gov processed this record on August 21, 2014