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

NCT00257556 | Completed Phase 4 Results

• 2 other identifiers: FE999906 CS004 (PROSPECT)2004-001307-35
• Study Type: interventional
• Target: 80
• Locations: 2 countries
• Sites: 6

Brief Summary

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

Conditions

Infertility

Outcome Measures

Primary Outcomes (2)

• Number of Participants With an Ongoing Pregnancy

  Number of participants who met human chorionic gonadotrophin (hCG) criterion, received an embryo transfer, tested positive with a serum pregnancy test 11-14 days after embryo transfer and had an ongoing pregnancy (defined as positive fetal heart action) at ≥ 9 weeks after the first positive pregnancy test.

  Approx week 13; 9 weeks or more after the 1st positive pregnancy test

• Percentage of Participants With an Ongoing Pregnancy

  Percentage of participants who had an ongoing pregnancy ≥ 9 weeks after the first positive pregnancy test, as indicated by positive fetal heart action.

  Approx week 13; 9 weeks or more after the first positive pregnancy test

Secondary Outcomes (9)

• 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)

• Participants With Varying Numbers of Oocytes Retrieved

  Approximately study day 15

• Participants With Varying Numbers of Pronuclear Stage Oocytes

  Approximately study day 15

• Participants With Varying Numbers of Embryos Transferred

  Approximately study day 17

• Participants With Varying Numbers of Embryos Frozen

  Approximately study day 17

Study Arms (2)

Menotrophin

EXPERIMENTAL

Drug: Menotrophin

Follitropin alfa

ACTIVE COMPARATOR

Drug: Follitropin alfa

Interventions

Menotrophin DRUG

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.

Also known as: Menopur, hMG, highly purified menotrophin

Menotrophin

Follitropin alfa DRUG

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.

Also known as: rFSH, recombinant FSH

Follitropin alfa

Eligibility Criteria

• Age: 20 Years - 35 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ferring Pharmaceuticals: lead

Study Sites (6)

Gemeinschaftspraxis und Tagesklinik, Olpe 19

Dortmund, 44135, Germany

Location

Universitats-Frauenklinik Heidelberg Abt. Gynakologische Endokrinologie und Fertilitatsstorungen, Voßstr. 9

Heidelberg, 69115, Germany

Location

Gemeinschaftspraxis und Tagesklinik, Zingel 29

Hildesheim, 1134, Germany

Location

Royal Infirmary of Edinburgh, 51 Little France

Edinburgh, EH16 4SA, United Kingdom

Location

Leeds General Infirmary, Great George Street

Leeds, LS1 3EX, United Kingdom

Location

The Royal Hallamshire Hospital, University of Sheffield, Jessop Wing, Tree Root Walk

Sheffield, S10 2SF, United Kingdom

Location

MeSH Terms

Conditions

Infertility

Interventions

Menotropins; follitropin alfa

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Gonadotropins, Pituitary; Gonadotropins; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Pituitary Hormones, Anterior; Pituitary Hormones; Peptides; Amino Acids, Peptides, and Proteins; Biological Products; Complex Mixtures

Results Point of Contact

• Title: Clinical Development Support
• Organization: Ferring Pharmaceuticals

DK0-Disclosure@ferring.com

Study Officials

• Clinical Development Support

  Ferring Pharmaceuticals

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: November 22, 2005
• First Posted: November 23, 2005
• Study Start: October 1, 2005
• Primary Completion: July 1, 2008
• Study Completion: April 1, 2009
• Last Updated: February 26, 2010
• Results First Posted: February 26, 2010

Record last verified: 2010-02

Locations

DE (3); GB (3)