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

Infertility Clinical Trial

— ESCORT  

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01149070
• Other study ID #: 700623-506
• Status: Completed
• Phase: N/A
• First received: May 28, 2010
• Last updated: September 12, 2014
• Start date: June 2009
• Est. completion date: December 2013

Study information

• Verified date: September 2014
• Source: Merck KGaA
• Contact: n/a
• Is FDA regulated: No
• Health authority: Hungary: Research Ethics Medical Committee
• Study type: Observational

Clinical Trial Summary

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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10103
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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 Design

Observational Model: Cohort

Related Conditions & MeSH terms

• Infertility

Locations

Country	Name	City	State
Hungary	Kaáli Institute	Budapest	Istenhegyi út 54/A

Sponsors (2)

Lead Sponsor	Collaborator
Merck KGaA	Merck Kft., Hungary

Country where clinical trial is conducted

Hungary, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	No
Primary	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)	Yes
Secondary	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)	No