Skip to main content
OpenTrials
Completed

NCT Number: NCT01183143

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

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).

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Infertility Genital Diseases In-vitro Fertilization Ovulation Induction Urogenital Diseases

Age range

18 year–43 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Please Contact the Merck KGaA Communication Center

Darmstadt, 64293, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Gonal-F®

Drug

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 names: Follitropin alpha

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Merck KGaA, Darmstadt, Germany

Industry

Registry information

Official study 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

Acronym: Prestyje

Important dates

Study start
2004
Primary completion
2006
Study completion
2006
First posted
Aug 17, 2010
Registry last updated
Apr 6, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.