Effect of a Higher Than Maximum 450IU Gonadotropin Dose in an In-vitro Fertilization Cycle
NCT ID: NCT00971152
Last Updated: 2014-03-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE3
366 participants
INTERVENTIONAL
2009-09-30
2014-02-28
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Optimal Stimulation of Hypo-responders Undergoing in Vitro Fertilization (IVF)
NCT07121751
Controlled Ovarian Stimulation Versus Modified Natural Cycles in Poor Responders
NCT04487925
Administration of Follicle-stimulating Hormone (FSH) and Low Dose Human Chorionic Gonadotropin (hCG) for Oocyte Maturity While Decreasing hCG Exposure in In Vitro Fertilization (IVF) Cycles
NCT02310919
Efficacy and Safety of Medication Used to Stimulate Ovulation
NCT02715336
Comparative Assessment of the Clinical Utility of Ovarian Stimulation With Menotropin Versus Menotropin Plus GnRH Antagonist
NCT01331733
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
450 IU daily dose of gonadotrophin
menotropins for injection
comparison of different dosages
urofollitropin for injection
comparison of different dosages
600 IU daily dose of gonadotrophin
menotropins for injection
comparison of different dosages
urofollitropin for injection
comparison of different dosages
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
menotropins for injection
comparison of different dosages
urofollitropin for injection
comparison of different dosages
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
Exclusion Criteria
* 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
* 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
18 Years
40 Years
FEMALE
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Ferring Pharmaceuticals
INDUSTRY
Clinique Ovo
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Louise Lapensee, MD
Role: PRINCIPAL_INVESTIGATOR
ovo fertilité
Jacques Kadoch, MD
Role: STUDY_DIRECTOR
OVO Fertilité and OVO R & D
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Ovo Fertilité
Montreal, Quebec, Canada
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Related Links
Access external resources that provide additional context or updates about the study.
OVO fertilité website
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
F-GYN-08-02
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.