An Observational Study to Evaluate Efficacy, Safety and Clinical Outcomes of Currently Used Pharmaceutical Therapies for Controlled Ovarian Stimulation in Assisted Reproductive Techniques (ESCORT)

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2012 by Merck KGaA
Sponsor:
Collaborator:
Merck Kft., Hungary
Information provided by (Responsible Party):
Merck KGaA
ClinicalTrials.gov Identifier:
NCT01149070
First received: May 28, 2010
Last updated: October 11, 2012
Last verified: October 2012
  Purpose

Human gonadotrophins have been successfully used for the treatment of infertility for more than 30 years. This observational study is being conducted to evaluate the efficacy and safety of the gonadotropins used for controlled ovarian stimulation (COS) in assisted reproductive technologies (ART).


Condition
Infertility

Study Type: Observational
Study Design: Observational Model: Cohort
Official Title: An Observational Program to Evaluate Efficacy, Safety and Clinical Outcomes of Currently Used Pharmaceutical Therapies for Controlled Ovarian Stimulation (COS) in Assisted Reproductive Techniques (ART)

Resource links provided by NLM:


Further study details as provided by Merck KGaA:

Primary Outcome Measures:
  • Efficacy of gonadotropins will be assessed by pregnancy outcome [ Time Frame: From the start of the program cycles up to 12 months (data will be collected prospectively for 12 months and also a substantial amount of cycles will be analyzed retrospectively for the previous 6 months) ] [ Designated as safety issue: No ]
    Duration and dose of gonadotropin; ovulation trigerring; cycle cancellation reasons; clinical pregnancy at week 8; gestational sac size; foetal heart beat; ectopic pregnancy; early pregnancy loss; ongoing pregnancy with fresh and frozen embryos; pregnancy outcome (number, weight, length and percentile of born children); endometrial thickness; number of oocytes per retrieval; size of leading follicle; number of oocytes fertilized; total number of embryos; number of fresh embryos transferred; fertilization rate; number of cryopreserved embryos per FET; mean quality score of transferred embryos.

  • Safety assessments include recording of adverse events (AEs), serious adverse events (SAEs), AE resulting in cancellation, drug related AEs, ovarian hyperstimulation syndrome [OHSS (mild, moderate, severe, none)]. [ Time Frame: From the start of the program cycles up to 12 months (data will be collected prospectively for 12 months and also a substantial amount of cycles will be analyzed retrospectively for the previous 6 months) ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Clinical outcomes of the various progesterone preparations will be monitored and registered by assessing clinical pregnancy [ Time Frame: From the start of the program cycles up to 12 months (data will be collected prospectively for 12 months and also a substantial amount of cycles will be analyzed retrospectively for the previous 6 months) ] [ Designated as safety issue: No ]

Estimated Enrollment: 8100
Study Start Date: June 2009
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Detailed Description:

The objective of this observational program is to evaluate the efficacy and safety of the gonadotropins used for COS in ART. The clinical use of the various progesterone preparations will also be monitored and registered. All medications will be used according to normal clinical practice, as described in the Summary of Product Characteristics (SmPC). From the start of the program cycles data will be collected prospectively for 12 months and also a substantial amount of cycles will be analyzed retrospectively for the previous 6 months. Data will be collected from all subjects stimulated by follicle stimulating hormone (FSH), with or without down regulation and exogenous lutenizing hormone (LH) supplementation, and final follicular maturation triggered by human chorionic gonadotropin (hCG) and luteal phase support by any means for COS in ART and intracytosolic sperm injection (ICSI). All the medications should be used according to usual clinical practice. Data related to pretreatment (basal examination, history of infertility, LH suppression), stimulation (gonadotropin use, concomitant medications, luteal phase supplementation, ovulation triggering, cycle cancellation, fertilization methods), safety aspects and clinical outcome will be captured.

  Eligibility

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

Female subjects undergoing ART

Criteria

Inclusion Criteria:

  • This is a registry wherein data will be collected from all subjects stimulated by FSH, with- or without down regulation and exogenous luteinising hormone (LH) supplementation, and final follicular maturation triggered by hCG and luteal phase support by any means for controlled ovarian stimulation (COS) in assisted reproductive technique (ART) and intracytoplasmic sperm injection (ICSI).
  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: NCT01149070

Contacts
Contact: Medical Director +36 1463 8100

Locations
Hungary
Kaáli Institute Recruiting
Budapest, Istenhegyi út 54/A, Hungary, 1125
Contact: Péter Kovács, MD    (+36-1) 202-2802      
Principal Investigator: Péter Kovács, MD         
Sponsors and Collaborators
Merck KGaA
Merck Kft., Hungary
Investigators
Principal Investigator: Péter Kovács, MD Kaáli Institute, Budapest
  More Information

No publications provided

Responsible Party: Merck KGaA
ClinicalTrials.gov Identifier: NCT01149070     History of Changes
Other Study ID Numbers: 700623-506
Study First Received: May 28, 2010
Last Updated: October 11, 2012
Health Authority: Hungary: Research Ethics Medical Committee

Keywords provided by Merck KGaA:
Infertility
Controlled ovarian stimulation
Reproductive techniques, assisted
Sperm injections, intracytoplasmic
Gonal-f
Ovitrelle

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

ClinicalTrials.gov processed this record on July 23, 2014