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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01312766
Recruitment Status : Completed
First Posted : March 11, 2011
Results First Posted : August 15, 2014
Last Update Posted : July 22, 2016
Information provided by (Responsible Party):
IBSA Institut Biochimique SA

Brief Summary:
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 or disease Intervention/treatment Phase
Infertility Drug: Menotropins Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 270 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (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)
Study Start Date : February 2011
Actual Primary Completion Date : April 2013
Actual Study Completion Date : December 2013

Resource links provided by the National Library of Medicine

Drug Information available for: Menotropins
U.S. FDA Resources

Arm Intervention/treatment
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.

Primary Outcome Measures :
  1. Total Number of Oocytes Retrieved [ Time Frame: up to 24 days after treatment start ]

Secondary Outcome Measures :
  1. Mean hMG Dose (Total); [ Time Frame: up to 22 days after treatment start ]
  2. Embryo Quality (Percentage of Patients With at Least One Top Quality Embryo) [ Time Frame: up to 28 days after treatment start ]
    Assessed by counting the total number of embryos obtained, the number of embryos transferred, frozen and discarded.

  3. Positive b-hCG Test [ Time Frame: up to 5 weeks after treatment start ]
  4. Controlled Ovarian Stimulation Duration (Days) [ Time Frame: up to 23 days after treatment start ]
  5. 17-β Estradiol (E2) Serum Concentration on the Monitoring Day Before hCG Injection; [ Time Frame: up to 23 days after treatment start ]
  6. Implantation Rate [ Time Frame: 10-11 weeks after embryo transfer ]
    defined as the mean of the total number of implanted embryos (presence of gestational sac assessed by ultrasound) divided by the total number of transferred embryos x 100;

  7. Clinical Pregnancy Rate, [ Time Frame: 10 - 11 weeks after embryo transfer ]
    defined as a pregnancy showing ultrasound embryonic heart activity at 10 - 11 weeks after embryo transfer;

  8. Number of Mature (Grade III Metaphase II) Oocytes Retrieved. [ Time Frame: at the end of the stimulation. ]
  9. Ratio Mature/Total Number of Oocytes Retrieved. [ Time Frame: at the end of the stimulation. ]
    Percentage of retrieved oocytes considered to be mature.

  10. Total Number of Inseminated Oocytes (IVF and ICSI) [ Time Frame: on the day of oocyte retrieval ]
    number of oocytes that were inseminated via IVF or injected via ICSI technique.

  11. Number of Cleaved Embryos [ Time Frame: two days after insemination ]
  12. Live Birth Rate [ Time Frame: 9 months after treatment ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01312766

Fertility clinic at Hvidovre Hospital
Hvidovre, Copenhagen, Denmark, 2650
Odense Universitetshospital
Odense, Odensee C, Denmark, 5000
Groupe Hospitalier Cochin - Saint Vincent de Paul
Paris, France, 75014
First Dept. Obstetric and Gynaecology, Semmelweiss University
Budapest, Hungary, 1088
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
Principal Investigator: Dominique De Ziegler, MD, Prof Hopital Cochin

Responsible Party: IBSA Institut Biochimique SA Identifier: NCT01312766     History of Changes
Other Study ID Numbers: 10EU/hMG02
2010-021021-13 ( EudraCT Number )
First Posted: March 11, 2011    Key Record Dates
Results First Posted: August 15, 2014
Last Update Posted: July 22, 2016
Last Verified: June 2016

Additional relevant MeSH terms:
Genital Diseases, Male
Genital Diseases, Female