Infertility Clinical Trial
— ESCORTOfficial 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)
Verified date | September 2014 |
Source | Merck KGaA |
Contact | n/a |
Is FDA regulated | No |
Health authority | Hungary: Research Ethics Medical Committee |
Study type | Observational |
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).
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). |
Observational Model: Cohort
Country | Name | City | State |
---|---|---|---|
Hungary | Kaáli Institute | Budapest | Istenhegyi út 54/A |
Lead Sponsor | Collaborator |
---|---|
Merck KGaA | Merck Kft., Hungary |
Hungary,
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 |
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