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

NCT01149070 | Completed

• 1 other identifier: 700623-506
• Study Type: observational
• Target: 10,103
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Infertility

Keywords

Infertility; Controlled ovarian stimulation; Reproductive techniques, assisted; Sperm injections, intracytoplasmic; Gonal-f; Ovitrelle

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• 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)

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Female subjects undergoing ART

You may qualify if:

• 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).

Sponsors & Collaborators

• Merck KGaA, Darmstadt, Germany: lead
• Merck Kft., Hungary: collaborator

Study Sites (1)

Kaáli Institute

Budapest, Istenhegyi Út 54/A, 1125, Hungary

Location

MeSH Terms

Conditions

Infertility; Helping Behavior

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases; Social Behavior; Behavior

Study Officials

• Péter Kovács, MD

  Kaáli Institute, Budapest

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 28, 2010
• First Posted: June 23, 2010
• Study Start: June 1, 2009
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: September 15, 2014

Record last verified: 2014-09

Locations

HU (1)