Safety and Efficacy Study in in Vitro Fertilisation (IVF) Patients

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
IBSA Institut Biochimique SA
ClinicalTrials.gov Identifier:
NCT01312766
First received: March 7, 2011
Last updated: March 27, 2013
Last verified: September 2012
  Purpose

The purpose of the non-inferiority study is to evaluate the clinical efficacy and the safety of two different subcutaneous hMG preparations when administered to patients undergoing controlled ovarian stimulation for IVF.


Condition Intervention Phase
Infertility
Drug: Menotropins
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: Safety and Efficacy Study Comparing a New hMG Formulation (hMG-IBSA) to a Reference Product (Menopur®) in Patients Undergoing Ovarian Stimulation for in Vitro Fertilisation (IVF)

Resource links provided by NLM:


Further study details as provided by IBSA Institut Biochimique SA:

Primary Outcome Measures:
  • Total number of oocytes retrieved [ Time Frame: up to 24 days after treatment start ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Mean hMG dose (daily and total); [ Time Frame: up to 22 days after treatement start ] [ Designated as safety issue: No ]
  • Oocyte quality [ Time Frame: up to 24 days after treatement start ] [ Designated as safety issue: No ]
    Assessed by Mean number of mature oocytes, Mean number of immature oocytes, Fertilization rate and Cleavage rate

  • Embryo quality [ Time Frame: up to 28 days after treatement start ] [ Designated as safety issue: No ]
    Assessed by counting the Total number of embryos obtained, the number of embryos transferred, frozen and discarded.

  • Positive b-hCG test per oocyte retrieval and per embryo transfer; [ Time Frame: up to 5 weeks after treatment start ] [ Designated as safety issue: No ]
  • Incidence of OHSS (according to Golan classification); [ Time Frame: up to 5 weeks after treatment start ] [ Designated as safety issue: Yes ]
    A special form will be used to assess OHSS incidence in all treated patients on the day of embryo transfer and on the day of serum pregnancy test.

  • Number of days of hMG stimulation; [ Time Frame: up to 22 days after treatment start ] [ Designated as safety issue: No ]
    The duration (in days) of the treatment will be recorded and analysed.

  • Number of follicles >16 mm on the day of hCG injection; [ Time Frame: up to 23 days after treatment start ] [ Designated as safety issue: No ]
  • 17-β estradiol (E2) serum concentration on the monitoring day before hCG injection; [ Time Frame: up to 23 days after treatment start ] [ Designated as safety issue: No ]
  • Cancellation rate with reasons; [ Time Frame: up to 23 days after treatment start ] [ Designated as safety issue: No ]
    the reason why a patient withdraw from the study will be recorded.

  • Implantation rate [ Time Frame: 10-11 weeks after embryo transfer ] [ Designated as safety issue: No ]
    defined as the ratio of the number of implanted embryos (presence of gestational sac assessed by ultrasound) and the number of transferred embryos;

  • Clinical pregnancy rate, [ Time Frame: 10 - 11 weeks after embryo transfer ] [ Designated as safety issue: No ]
    defined as a pregnancy showing ultrasound embryonic heart activity at 10 - 11 weeks after embryo transfer;

  • Adverse Events (AEs) (time of onset, severity, duration and action/treatment required); [ Time Frame: up to 15 weeks after treatment start ] [ Designated as safety issue: Yes ]
    All AEs observed while patients are on-protocol (i.e. untill 10-11 weeks after ET), regardless of classification, will be followed until resolution or stabilisation (if chronic).

  • Local tolerability at the injection site; [ Time Frame: up to 23 days after treatment start ] [ Designated as safety issue: Yes ]
    patient's tolerance to the hMG injections will be assessed by the investigator at each visit

  • Overall assessment of health; [ Time Frame: up to 23 days after treatment start ] [ Designated as safety issue: Yes ]
    The patient's general well being will be assessed at each visit.


Estimated Enrollment: 272
Study Start Date: February 2011
Estimated Study Completion Date: October 2013
Estimated Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: hMG-IBSA
New hMG preparation.
Drug: Menotropins
Daily administration, SC, starting dose 150 IU or 225 IU depending on patient age.
Active Comparator: Menopur Drug: Menotropins
Daily administration, SC, starting dose 150 IU or 225 IU depending on patient age.

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Women undergoing ovarian stimulation for IVF with the following characteristics:

    • Able and willing to sign the Patient Consent Form and adhere to the study visitation schedule
    • >18 and <40 years old
    • BMI between 18 and 30 kg/m2
    • less than 3 previously completed IVF cycles (i.e. completed cycle = egg recovery)
    • basal FSH <10 IU/L and E2 <80 pg/ml (~290 pmol/l)
    • Within 12 months of the beginning of the study, uterine cavity consistent with expected normal function as assessed through transvaginal ultrasound, hysterosalpingogram, sonohysterogram or hysteroscopic examination
    • Successful down-regulation performed with a standard GnRH-Agonist long protocol (Criteria for successful down-regulation: endometrial thickness < 7mm or serum E2 level <50 pg/ml (~185 pmol/l).

Exclusion Criteria:

  • age <18 and >40 years
  • primary ovarian failure or women known as poor responders (i.e. requiring more than 225 IU of hMG as a starting dose in previous treatment cycles or having less than 3 oocytes retrieved, or with a pre-ovulatory E2 serum concentration <500pg/ml (~1800 pmol/l))
  • PCOS
  • one or both ovaries inaccessible for oocyte retrieval
  • ovarian cysts >10 mm
  • hydrosalpinx that have not been surgically removed or ligated;
  • stage 3 or 4 endometriosis
  • oocyte donation
  • implantation of previously frozen embryos
  • patients affected by pathologies associated with any contraindication of being pregnant
  • hypersensitivity to the study medication
  • abnormal bleeding of undetermined origin
  • uncontrolled thyroid or adrenal dysfunction
  • neoplasias
  • severe impairment of renal and/or hepatic function
  • use of concomitant medications that might interfere with study evaluations (e.g. non-study hormonal medications, prostaglandin inhibitors, psychotropic agents)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01312766

Locations
Denmark
Fertility clinic at Hvidovre Hospital
Hvidovre, Copenhagen, Denmark, 2650
Odense Universitetshospital
Odense, Odensee C, Denmark, 5000
France
Groupe Hospitalier Cochin - Saint Vincent de Paul
Paris, France, 75014
Hungary
First Dept. Obstetric and Gynaecology, Semmelweiss University
Budapest, Hungary, 1088
Switzerland
Universitätsspital Basel
Basel, BS, Switzerland, 4031
United Kingdom
Midland Fertility Services
Aldridge, West Midlands, United Kingdom, WS9 8LT
Sponsors and Collaborators
IBSA Institut Biochimique SA
Investigators
Principal Investigator: Dominique De Ziegler, MD, Prof Hopital Cochin
  More Information

No publications provided

Responsible Party: IBSA Institut Biochimique SA
ClinicalTrials.gov Identifier: NCT01312766     History of Changes
Other Study ID Numbers: 10EU/hMG02, 2010-021021-13
Study First Received: March 7, 2011
Last Updated: March 27, 2013
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Denmark: Danish Medicines Agency
Hungary: National Institute of Pharmacy
Switzerland: Swissmedic

Additional relevant MeSH terms:
Infertility
Genital Diseases, Male
Genital Diseases, Female
Menotropins
Fertility Agents, Female
Fertility Agents
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on July 22, 2014