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SubfertilityPhase 3NCT00971152

Effect of a Higher Than Maximum 450IU Gonadotropin Dose in an In-vitro Fertilization Cycle

A Phase 3 study testing menotropins for injection and urofollitropin for injection in people with Subfertility, run by Clinique Ovo at 1 site in Canada.

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

This goal of this study is to evaluate the outcomes from in vitro fertilization cycles where a 450 IU daily dose of gonadotropins is administered compared to those where a 600 IU daily dose is administered for women who are at risk of a poor ovarian response in order to determine if one dose or the other results in… Read more about this study

Who is it for?
Ages 18 to 40 years, women onlyHealthy volunteers can take part
Conditions the study is for
Subfertility
What is being tested?
menotropins for injection and urofollitropin for injection
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
366 participants
Where
1 siteCanada
Study dates
Sep 2009to Feb 2014
Phase
Phase 3
Are there results?
None posted in the registry

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 18 to 40 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • RESIDENT OF CANADA
  • Premenopausal
  • Age 40 years or less at the time of enrollment
  • At risk of a poor ovarian response defined as: either <5 oocytes or <8 follicles in a previous cycle, FSH > 10 IU/L, AMH < 1 pg/ml , antral follicle count less or equal to 8 or previous IVF cancellation
  • Primary infertility or secondary
  • Not previously undertaken a cycle that was included in this study

Who cannot join

  • Simultaneous participation in another clinical trial
  • Body mass index (BMI) > 38 kg/m2
  • Early follicular phase (day 2-4) serum FSH level > 20 mIU/ml
  • Any contraindication to being pregnant and carrying a pregnancy to term
  • Contraindication for the use of Estrace® , Suprefact®, Menopur®, Bravelle®, hCG, and luteal phase support medication
  • Any ovarian or abdominal abnormality that may interfere with adequate transvaginal ultrasound evaluation
Show all 10Show fewer
  • Administration of any investigational drugs within three months prior to study enrollment
  • Patient not able to communicate adequately with the investigators and to comply with the requirements of the entire study
  • Positive results of screening of either partner for HIV antibodies, Hepatitis B (other than for surface antibodies present after vaccination) or Hepatitis C
  • Unwillingness to give written informed consent

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • Ovo Fertilité

    Montreal, Quebec, H4P 2S4

Other trials in Canada

About this study

Official title: Effect of a Higher Than Maximum 450IU Gonadotropin Dose on Patient Outcomes in an In-Vitro Fertilization Setting: a Randomized Controlled Non-infertility Trial

This goal of this study is to evaluate the outcomes from in vitro fertilization cycles where a 450 IU daily dose of gonadotropins is administered compared to those where a 600 IU daily dose is administered for women who are at risk of a poor ovarian response in order to determine if one dose or the other results in improved cycle outcomes.

Conditions
Subfertility
Being tested
menotropins for injection, urofollitropin for injection
Keywords
IVF, dose comparison of gonadotrophins, poor responder to ovarian stimulation
Medical subject headings
Infertility

What participants receive

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

  • menotropins for injectionDrug

    Also called Menopur

    comparison of different dosages

  • urofollitropin for injectionDrug

    Also called Bravelle

    comparison of different dosages

Study groups in NCT00971152
Study groupRoleWhat they receive
450 IU daily dose of gonadotrophinActive comparatorNot described
Receives: Drug: menotropins for injection; Drug: urofollitropin for injection
600 IU daily dose of gonadotrophinExperimentalNot described
Receives: Drug: menotropins for injection; Drug: urofollitropin for injection

What is being measured

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

  1. Number of metaphase II oocytes retrieved during the course of one treatment cycle

    Measured: 2 years

Secondary outcomes (12)

  1. Number of follicles recruited per patient during stimulation

    Measured: 2 years

  2. Fertilization rate per patient (number of normally fertilized (with 2 pronuclei) oocytes/number of mature oocytes collected)

    Measured: 2 years

  3. Embryo cleavage rate per patient (number of divided normally fertilized oocytes/number of normally fertilized oocytes)

    Measured: 2 years

  4. Number of embryos available per patient

    Measured: 2 years

  5. Number of supernumerary embryos available for cryopreservation per patient

    Measured: 2 years

  6. Implantation rate

    Measured: 2 years

  7. Biochemical pregnancy rate

    Measured: 2 years

  8. Clinical pregnancy rate

    Measured: 2 years

  9. Rate of multiple gestation

    Measured: 2 years

  10. Ongoing pregnancy rate

    Measured: 2 years

  11. Live birth rate

    Measured: 2 years

  12. rate of occurrence of ovarian hyperstimulation syndrome (OHSS)

    Measured: 2 years

Timeline

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

  1. First posted3 Sep 2009 (estimated)
  2. Study startSep 2009
  3. Primary completionOct 2013
  4. Study completionFeb 2014

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
366 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00971152
Sponsor's protocol ID
F-GYN-08-02
Status last verified
Mar 2014
First submitted
2 Sep 2009
Last updated
13 Mar 2014
Results posted
No
Data monitoring committee
No

Publications

  • Srouji SS, Missmer SA, Ginsburg ES (2004) Impact of increasing gonadotropins > 450 IU on cycle outcome. Brigham and Women's Hospital, Boston, MA. Fertil Steril 82 (Suppl 2): P292.

  • Flisser E, Krey LC, Berkeley AS (2005) Diminishing Returns of Increasing Gonadotropin Dosage in Subsequent In Vitro Fertilization (IVF) Cycles?. Fertil Steril 84 (Suppl 1) P483.

  • Lefebvre J, Antaki R, Kadoch IJ, Dean NL, Sylvestre C, Bissonnette F, Benoit J, Menard S, Lapensee L. 450 IU versus 600 IU gonadotropin for controlled ovarian stimulation in poor responders: a randomized controlled trial. Fertil Steril. 2015 Dec;104(6):1419-25. doi: 10.1016/j.fertnstert.2015.08.014. Epub 2015 Sep 8.

    PubMed 26361207

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing menotropins for injection and urofollitropin for injection in people with Subfertility, run by Clinique Ovo at 1 site in Canada.

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 6 inclusion and 10 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 13 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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 metaphase II oocytes retrieved during the course of one treatment cycle (time frame: 2 years). 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 NCT00971152, which also lists 3 linked publications.

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 13 Mar 2014.

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