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InfertilityPhase 4NCT00257556

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

A Phase 4 study testing Menotrophin and Follitropin alfa in people with Infertility, run by Ferring Pharmaceuticals at 6 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Prospective open label, randomised, parallel group, comparative pilot. Read more about this study

Who is it for?
Ages 20 to 35 years, women onlyHealthy volunteers can take part
Conditions the study is for
Infertility
What is being tested?
Menotrophin and Follitropin alfa
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
80 participants
Where
6 sitesin 2 countries
Study dates
Oct 2005to Apr 2009
Phase
Phase 4
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 35 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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;
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  • 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.

Who cannot join

  • 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;
Show all 14Show fewer
  • 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.

Trial locations and contacts

6 sites in 2 countries.

6 sites in 2 countries

Germany3 sites

  • Gemeinschaftspraxis und Tagesklinik, Olpe 19

    Dortmund, 44135

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

    Heidelberg, 69115

  • Gemeinschaftspraxis und Tagesklinik, Zingel 29

    Hildesheim, 1134

Other trials in Germany

United Kingdom3 sites

  • Royal Infirmary of Edinburgh, 51 Little France

    Edinburgh, EH16 4SA

  • Leeds General Infirmary, Great George Street

    Leeds, LS1 3EX

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

    Sheffield, S10 2SF

Other trials in United Kingdom

About this study

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.

Read the 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
Being tested
Menotrophin, Follitropin alfa
Medical subject headings
Infertility

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MenotrophinDrug

    Also called Menopur, hMG, highly purified 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.

  • Follitropin alfaDrug

    Also called rFSH, recombinant FSH

    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.

Study groups in NCT00257556
Study groupRoleWhat they receive
MenotrophinExperimentalNot described
Receives: Drug: Menotrophin
Follitropin alfaActive comparatorNot described
Receives: Drug: Follitropin alfa

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

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

  2. 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.

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

Secondary outcomes (9)

  1. Participants With Varying Numbers of Follicles That Were Greater Than or Equal to 17 Millimeters

    The criterion for ovulation induction was three follicles ≥ 17 mm diameter as shown by pelvic ultrasound examination. Patients were assessed by pelvic ultrasound on the morning (prior to menotrophin or follitropin alfa administration) of Day 7 and, if appropriate, every 2 days thereafter (Days 9/11/13) until the criterion was met.

    Measured: Day 7 and, if appropriate, every 2 days thereafter (Days 9/11/13)

  2. Participants With Varying Numbers of Oocytes Retrieved

    Number of participants with grouped by the number of oocytes retrieved. Oocytes were retrieved following ovulation induction by subcutaneous administration of human chorionic gonadotrophin (hCG) in the form of choriogonadotropin alfa at a dose of 250 micrograms once participants reached the criteria of at least three follicles with >= 17mm in diameter.

    Measured: Approximately study day 15

  3. Participants With Varying Numbers of Pronuclear Stage Oocytes

    Number of participants with various groupings of pronuclear oocytes retrieved 16-20 hours after insemination.

    Measured: Approximately study day 15

  4. Participants With Varying Numbers of Embryos Transferred

    Number of participants with various categories of numbers of embryos transferred.

    Measured: Approximately study day 17

  5. Participants With Varying Numbers of Embryos Frozen

    Number of participants with different categories of number of embryos frozen.

    Measured: Approximately study day 17

  6. Mean Number of Days Stimulated With Gonadotrophins

    Number of days stimulated with study drug until participant met the criteria for ovulation induction. Ovulation induction criteria is three follicles greater than or equal to 17 mm diameter as shown by pelvic ultrasound examination.

    Measured: study days 1 - 13

  7. Pregnancy Outcomes

    Long term follow-up to determine the outcome of the pregnancy.

    Measured: Approximately 10 months

  8. Mean Endometrial Thickness

    Measurement performed on day of human chorionic gonadotrophin (hCG) administration/ovulation induction.

    Measured: Day 7 or 9 or 11 or 13

  9. Mean Estradiol Level

    Measurement on day of human chorionic gonadotrophin (hCG) administration / ovulation induction.

    Measured: Day 7 or 9 or 11 or 13

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Nov 2005 (estimated)
  2. Study startOct 2005
  3. Primary completionJul 2008
  4. Study completionApr 2009

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
80 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00257556
Sponsor's protocol ID
FE999906 CS004 (PROSPECT)
Other IDs
2004-001307-35, 2004
Status last verified
Feb 2010
First submitted
22 Nov 2005
Last updated
26 Feb 2010
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Menotrophin and Follitropin alfa in people with Infertility, run by Ferring Pharmaceuticals at 6 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Feb 2010. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in Germany, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 26 Feb 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With an Ongoing Pregnancy (time frame: Approx week 13; 9 weeks or more after the 1st positive pregnancy test). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00257556.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Feb 2010.

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