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Convenience and Safety of Assisted Reproductive Technology Procedures Using a Gonal-F Filled by Mass (Fbm) Liquid Formulation Applied by Pen for Ovulation Induction and In-vitro Fertilization (Prestyje)

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ClinicalTrials.gov Identifier: NCT01183143
Recruitment Status : Completed
First Posted : August 17, 2010
Results First Posted : April 6, 2018
Last Update Posted : April 6, 2018
Sponsor:
Information provided by (Responsible Party):
Merck KGaA

Brief Summary:
This was a prospective, open-label, non-comparative, Phase IIIb trial to assess the convenience, safety and efficacy of the new Gonal-F fbm [recombinant follicle stimulating hormone (r-FSH)] liquid formulation, in common setting for ovulation induction (OI) and also in in-vitro fertilization (IVF).

Condition or disease Intervention/treatment Phase
Infertility Ovulation Induction In-Vitro Fertilization Drug: GONAL-f® Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 215 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multicentre, Open-label, Non-comparative Phase IIIb Study to Evaluate the Acceptability of GONAL-f® Prefilled Liquid Formulation Administered by Pen in an Outpatient Setting for Ovarian Stimulation
Actual Study Start Date : May 11, 2004
Actual Primary Completion Date : March 2, 2006
Actual Study Completion Date : March 2, 2006

Arm Intervention/treatment
Experimental: GONAL-f® Drug: GONAL-f®
GONAL-f® will be administered subcutaneously to subjects between Day 2 and Day 5 of their cycle with a starting dose of 75 International Units (IU) per day for subjects who undergo ovulation induction (OI)/artificial insemination (IUI) and between 150 and 225 IU per day for subjects who undergo in-vitro fertilization (IVF). For subjects who undergo OI/IUI, the dose will be increased by 37.5 IU after Day 14 up to Week 4 if no ovarian response is observed.
Other Name: Follitropin alpha




Primary Outcome Measures :
  1. Number of Subjects Who Self-administered the Investigational Medicinal Product (IMP) [ Time Frame: Up to 1 year ]
    Number of subjects who self-administered the IMP were presented in this outcome measure.


Secondary Outcome Measures :
  1. Global Evaluation of the GONAL-f® Prefilled Pen by the Investigator [ Time Frame: Up to 1 year ]
    Investigator evaluated the use of GONAL-f® prefilled pen in subjects as very satisfactory, satisfactory and average satisfaction.

  2. Evaluation of the Information Given to the Subjects on the Pen's Utilization [ Time Frame: Up to 1 year ]
    Subjects were provided with the information on Pen's utilization via training session and in the form of information brochure. Subjects assessed both the methods using the following responses: satisfactory, satisfactory, unsatisfactory and very unsatisfactory.

  3. Duration of Ovarian Stimulation With GONAL-f® [ Time Frame: Up to 1 year ]
    Stimulation duration was defined as the duration (in days) for which subjects underwent GONAL-f® treatment.

  4. Mean Number of Embryos Transferred [ Time Frame: End of Stimulation period (up to a maximum 26 days) ]
  5. Total and Average Daily Dose of GONAL-f® [ Time Frame: Up to 26 days ]
  6. Pregnancy Rate in Subjects Receiving Stimulation by Ovulation Induction (OI) or Artificial Insemination (IUI) [ Time Frame: Up to 20 Weeks of Gestation ]
    Pregnancy rate was defined as the percentage of subjects with diagnosis of pregnancy, who underwent OI/IUI. Clinical pregnancy: Evidence of pregnancy by clinical or ultrasound parameters at 12 weeks after fertilization. Biochemical pregnancy: Evidence of conception based only on biochemical data in the serum or urine before ultrasound evidence of a gestational sac. Ongoing pregnancy was defined when the pregnancy had completed 20 weeks of gestation.

  7. Number of Subjects With Live Birth [ Time Frame: End of Gestation period, assessed up to a maximum of 1 year ]
    Number of subjects whose stimulation with the IMP resulted in the birth of a baby were reported.

  8. Number of Subjects With Local Tolerance at GONAL-f ® Injection Site as Assessed by Investigator [ Time Frame: Up to 1 year ]
    Local tolerance at the GONAL-f ® injection site was assessed for the presence of pain, swelling/welt, redness, itch and haematoma.

  9. Number of Subjects With at Least 1 Adverse Event [ Time Frame: Up to 1 year ]
    An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerged or worsened relative to baseline (i.e. present at the initial study visit) during a clinical study with an investigational product, regardless of causal relationship and even if no investigational product has been administered.

  10. Number of Subjects Taking at Least 1 Concomitant Treatment [ Time Frame: Up to 1 year ]


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Ages Eligible for Study:   18 Years to 43 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Female subjects aged between 18 and 43 years
  • Ambulatory subjects
  • Subjects who are willing to get pregnant and are infertile, that justifies ovarian stimulation treatment for mono-/pauci-follicular development (OI or IUI) or multiple follicular development for IVF/Intracytoplasmic Sperm Injection (ICSI) procedures
  • Subjects who are able to communicate well with the investigator and to comply with the requirements of the entire study
  • Subjects who have given written informed consent, prior to treatment

Exclusion Criteria:

  • Subjects with enlarged ovaries or cysts unrelated to polycystic ovaries
  • Subjects with extra-uterine pregnancy during the last 3 months
  • Subjects with several endometriosis (Grade III & IV)
  • Subjects with history of severe ovarian hyperstimulation syndrome
  • Subjects with history of thromboembolic event
  • Subjects with malformative uterine pathology that could disturb either implantation or pregnancy processes
  • Subjects with premature menopause
  • Subjects with gynecological bleeding of unknown origin
  • Subjects with ovarian, uterine, or mammary cancer
  • Subjects with tumors of the hypothalamus or the pituitary glands
  • Subjects with history of serious allergy or atopic asthma disease
  • Subjects with known allergic reaction against one of the Follicle Stimulating Hormone (FSH) and ingredients,
  • Ongoing pregnant, or breast feeding subjects
  • Subjects who have participated in a trial during the last 3 months

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 ClinicalTrials.gov identifier (NCT number): NCT01183143


Locations
Germany
Please Contact the Merck KGaA Communication Center
Darmstadt, Germany, 64293
Sponsors and Collaborators
Merck KGaA
Investigators
Study Director: Medical Responsible Merck KGaA

Responsible Party: Merck KGaA
ClinicalTrials.gov Identifier: NCT01183143     History of Changes
Other Study ID Numbers: IMP 25040
First Posted: August 17, 2010    Key Record Dates
Results First Posted: April 6, 2018
Last Update Posted: April 6, 2018
Last Verified: April 2018

Keywords provided by Merck KGaA:
Infertility
Ovulation induction
Gonal-F
Follitropin alpha
Controlled ovarian stimulation

Additional relevant MeSH terms:
Infertility
Genital Diseases, Male
Genital Diseases, Female
Follicle Stimulating Hormone
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs