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

NCT ID: NCT00257556

Last Updated: 2010-02-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-10-31
• Study Completion Date: 2009-04-30

Brief Summary

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

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.

Conditions

Infertility

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Menotrophin

Group Type: EXPERIMENTAL

Menotrophin

Intervention Type: 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.

Follitropin alfa

Group Type: ACTIVE_COMPARATOR

Follitropin alfa

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DRUG

Other Intervention Names

Menopur; hMG; highly purified menotrophin; rFSH; recombinant FSH

Eligibility 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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Ferring Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Ferring Pharmaceuticals

Principal Investigators

Clinical Development Support

Role: STUDY_DIRECTOR

Ferring Pharmaceuticals

Locations

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, , Germany

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, , United Kingdom

Countries

Germany; United Kingdom

Other Identifiers

2004-001307-35

Identifier Type: REGISTRY

Identifier Source: secondary_id

FE999906 CS004 (PROSPECT)

Identifier Type: -

Identifier Source: org_study_id