An Observational Study of Cetrotide® Gonadotropin-releasing Hormone Antagonist (GnRH Antagonist) With GONAL-f® in Assisted Reproductive Technologies (ART)

This study has been completed.
Sponsor:
Collaborator:
Merck Pte. Ltd., Singapore
Information provided by (Responsible Party):
Merck KGaA
ClinicalTrials.gov Identifier:
NCT01109654
First received: April 22, 2010
Last updated: July 15, 2014
Last verified: January 2012
  Purpose

This is a multicentric, prospective, observational study on the use of Cetrotide to control the endogenous gonadotrophin levels in Gonal-f stimulated ART treatment cycles in the Asia-Pacific region. The study plans to enrol approximately 1800-2000 subjects over a 9-month period at each participating centre.

This observational study is initiated to collect information on the use of Cetrotide (GnRH antagonist) in ART cycles in routine practice across the Asia-Pacific region. The information will allow a better understanding of the current ovarian stimulation regimens that involve Cetrotide in the control of the endogenous gonadotrophin concentrations. The collection of live birth data, though a challenging task, as a secondary endpoint will allow the study to show valuable information on the final objective of ART. To minimize the potential variability due to the different ovarian stimulation agents, the study is to include cycles treated with Gonal-f (recombinant human FSH) since this agent is widely available in the region.


Condition Intervention
Infertility
Drug: Cetrorelix acetate and Follitropin alfa

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: A Prospective, Observational Study on the Use of Cetrotide (GnRH Antagonist) With GONAL-f in Assisted Reproductive Technologies (ART)

Resource links provided by NLM:


Further study details as provided by Merck KGaA:

Primary Outcome Measures:
  • Proportion of subjects achieving a clinical pregnancy. [ Time Frame: At post hCG days 35-42 ] [ Designated as safety issue: No ]
    A transvaginal ultrasound scan will be performed on all subjects who become pregnant provided that no miscarriage has occurred.


Secondary Outcome Measures:
  • Proportion of subjects with cancelled cycles [ Time Frame: 3 month ] [ Designated as safety issue: No ]
  • Proportion of women with OHSS or risk of OHSS [ Time Frame: 3 month ] [ Designated as safety issue: Yes ]
  • Duration and dose of Cetrotide administered [ Time Frame: 3 month ] [ Designated as safety issue: No ]
  • Assessment of baseline characteristics [ Time Frame: 3 month ] [ Designated as safety issue: No ]
    Assessment of subjects age, weight, height, FSH and LH level prior to Gonal-f administration, concomitant treatment, infertility history and infertility treatment

  • Total dose of Gonal-f administered [ Time Frame: 3 month ] [ Designated as safety issue: No ]
  • Duration of ovarian stimulation [ Time Frame: 3 month ] [ Designated as safety issue: No ]
  • Number of oocytes retrieved [ Time Frame: 3 month ] [ Designated as safety issue: No ]
  • Number of subjects with Adverse Events [ Time Frame: 3 month ] [ Designated as safety issue: Yes ]
  • Pregnancy rate [ Time Frame: 12 month ] [ Designated as safety issue: No ]
  • Live birth rate [ Time Frame: 12 month ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

Plasma, Serum, Tissue, Urine


Enrollment: 2175
Study Start Date: September 2008
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Cetrorelix acetate and Follitropin alfa
    Cetrorelix acetate given either as a single-dose regimen of 3 mg injection or as a multiple-dose regimen of 0.25 mg daily injection.Ovarian stimulation therapy with Follitropin alfa generally starts on cycle Day 2 or 3. The starting dose of Follitropin alfa is based on the Investigators' discretion
    Other Names:
    • Cetrotide
    • Gonal-f
Detailed Description:

Gonadotrophin-releasing hormone (GnRH) antagonists were introduced in the beginning of this decade for the use in ART. The potential advantages of GnRH antagonists over the GnRH agonists include the avoidance of an acute stimulation of endogenous gonadotrophins and a dramatic reduction in the length of analogue treatment.

Despite the plus points of GnRH antagonists in ART, there has been some concern over the lower pregnancy rate reported, which may be the cause of a lower acceptance of GnRH antagonists in ovarian stimulation for in vitro fertilization (IVF). Interestingly, a separate meta-analysis did not reach the same finding. The probability of live birth after ovarian stimulation for IVF was found not to be dependent on the type of analogue used for pituitary suppression Cetrotide, a GnRH antagonist from Merck Serono, is currently approved for the inhibition of premature luteinizing hormone (LH) surges in women undergoing controlled ovarian stimulation in majority of the regions. It is given either as a single-dose regimen of 3 mg injection or as a multiple-dose regimen of 0.25 mg daily injection. Both regimens have been shown to offer equivalent efficacy and safety outcomes.

OBJECTIVES:

Primary objective:

  • To assess the effectiveness of Cetrotide regimens, when used with Gonal-f, in routine ART treatment cycles

Secondary objectives:

  • To assess the effectiveness of Cetrotide regimens on other efficacy endpoints
  • To survey the types of Cetrotide regimen used and their success rates
  • To assess the safety of Cetrotide regimens
  • To explore the association between subject characteristics and treatment outcomes
  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Female subjects undergoing controlled ovarian stimulation.

Criteria

Inclusion Criteria:

  • Subjects who are undergoing ovarian stimulation for IVF or ICSI therapy
  • Decision by treating physician to prescribe Gonal-f for controlled ovarian stimulation prior to study enrolment
  • Decision by treating physician to prescribe Cetrotide as the down-regulation agent prior to study enrolment

Exclusion Criteria:

  • Subjects using GnRH agonist as the down-regulation agent
  • Contraindicated use of Cetrotide based on local label
  • Subjects who have participated in the study previously
  • Subjects with hypersensitivity to cetrorelix acetate, extrinsic peptide hormones or mannitol
  • Subjects with known hypersensitivity to GnRH or any other GnRH analogs
  • Subjects with known or suspected pregnancy, and lactation
  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: NCT01109654

Locations
Singapore
Singapore General Hospital Pte Ltd, Outram Road
Singapore, Singapore, 609927
Sponsors and Collaborators
Merck KGaA
Merck Pte. Ltd., Singapore
Investigators
Study Director: Medical Director Merck Pte. Ltd., Singapore
  More Information

No publications provided

Responsible Party: Merck KGaA
ClinicalTrials.gov Identifier: NCT01109654     History of Changes
Other Study ID Numbers: EMR200088-500
Study First Received: April 22, 2010
Last Updated: July 15, 2014
Health Authority: Singapore: Health Sciences Authority

Keywords provided by Merck KGaA:
Fertilization in Vitro
Reproductive Techniques, Assisted
Follicle Stimulating Hormone
Cetrotide
Gonal-f

Additional relevant MeSH terms:
Infertility
Genital Diseases, Male
Genital Diseases, Female
Hormone Antagonists
Cetrorelix
Follicle Stimulating Hormone
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Hormones
Fertility Agents, Female
Fertility Agents
Reproductive Control Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 20, 2014