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

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)

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).

Study Overview

• Status: Completed
• Conditions: Infertility

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.

• Study Type: Observational
• Enrollment (Actual): 10103

Contacts and Locations

Study Locations

• Hungary
  • Istenhegyi út 54/A
    • Budapest, Istenhegyi út 54/A, Hungary, 1125
      • Kaáli Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Female subjects undergoing ART

Description

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).

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Efficacy of gonadotropins will be assessed by pregnancy outcome	Duration and dose of gonadotropin; ovulation triggering; 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.	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)
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)].		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)

Secondary Outcome Measures

Outcome Measure	Time Frame
Clinical outcomes of the various progesterone preparations will be monitored and registered by assessing clinical pregnancy	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)

Collaborators and Investigators

• Sponsor: Merck KGaA, Darmstadt, Germany
• Collaborators: Merck Kft., Hungary
• Investigators: Principal Investigator: Péter Kovács, MD, Kaáli Institute, Budapest

Study record dates

Study Major Dates

• Study Start: June 1, 2009
• Primary Completion (Actual): December 1, 2013
• Study Completion (Actual): December 1, 2013

Study Registration Dates

• First Submitted: May 28, 2010
• First Submitted That Met QC Criteria: June 22, 2010
• First Posted (Estimate): June 23, 2010

Study Record Updates

• Last Update Posted (Estimate): September 15, 2014
• Last Update Submitted That Met QC Criteria: September 12, 2014
• Last Verified: September 1, 2014

More Information

Terms related to this study

• Keywords: Infertility; Controlled ovarian stimulation; Reproductive techniques, assisted; Gonal-f; Sperm injections, intracytoplasmic; Ovitrelle
• Additional Relevant MeSH Terms: Infertility
• Other Study ID Numbers: 700623-506