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

NCT00971152 | Completed Phase 3

• 1 other identifier: F-GYN-08-02
• Study Type: interventional
• Target: 366
• Locations: 1 country
• Sites: 1

Brief 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 improved cycle outcomes.

Conditions

Subfertility

Keywords

IVF; dose comparison of gonadotrophins; poor responder to ovarian stimulation

Outcome Measures

Primary Outcomes (1)

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

  2 years

Secondary Outcomes (12)

• Number of follicles recruited per patient during stimulation

  2 years

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

  2 years

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

  2 years

• Number of embryos available per patient

  2 years

• Number of supernumerary embryos available for cryopreservation per patient

  2 years

Study Arms (2)

450 IU daily dose of gonadotrophin

ACTIVE COMPARATOR

Drug: menotropins for injection; Drug: urofollitropin for injection

600 IU daily dose of gonadotrophin

EXPERIMENTAL

Drug: menotropins for injection; Drug: urofollitropin for injection

Interventions

menotropins for injection DRUG

comparison of different dosages

Also known as: Menopur

450 IU daily dose of gonadotrophin; 600 IU daily dose of gonadotrophin

urofollitropin for injection DRUG

comparison of different dosages

Also known as: Bravelle

450 IU daily dose of gonadotrophin; 600 IU daily dose of gonadotrophin

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Clinique Ovo: lead
• Ferring Pharmaceuticals: collaborator

Study Sites (1)

Ovo Fertilité

Montreal, Quebec, H4P 2S4, Canada

Location

Related Publications (3)

• 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.

  BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 26361207 DERIVED

Related Links

• OVO fertilité website

MeSH Terms

Conditions

Infertility

Interventions

Menotropins; Injections; Urofollitropin

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; Drug Administration Routes; Drug Therapy; Therapeutics

Study Officials

• Louise Lapensee, MD

  ovo fertilité

  PRINCIPAL INVESTIGATOR

• Jacques Kadoch, MD

  OVO Fertilité and OVO R & D

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 2, 2009
• First Posted: September 3, 2009
• Study Start: September 1, 2009
• Primary Completion: October 1, 2013
• Study Completion: February 1, 2014
• Last Updated: March 13, 2014

Record last verified: 2014-03

Locations

CA (1)