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Clinical Trials/CTRI/2012/07/002770
CTRI/2012/07/002770
Completed
未知

A study to evaluate the impact of different controlled ovarian stimulation protocols on physical and psychological burden in patients undergoing In-Vitro Fertilization/In-Vitro Cytoplasmic Sperm Injection

Organon India Pvt Limited0 sites669 target enrollmentTBD
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ConditionsHealth Condition 1: null- Women between the age of 18-45 diagnosed or being treated for Infertility

Overview

Phase
未知
Intervention
Not specified
Conditions
Health Condition 1: null- Women between the age of 18-45 diagnosed or being treated for Infertility
Sponsor
Organon India Pvt Limited
Enrollment
669
Status
Completed
Last Updated
4 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
4 years ago
Study Type
Observational

Investigators

Sponsor
Organon India Pvt Limited

Eligibility Criteria

Inclusion Criteria

  • •Each subject must be female who will be undergoing Controlled Ovarian Stimulation (COS) as a part of first cycle IVF ICSI using recombinant Follicle Stimulating Hormone (rFSH using pen delivery system) with GnRH antagonist (eg ganirelix or cetrorelix) protocol, or a female using Human Menopausal Gonadotropin (hMG) with conventional long GnRH agonist, or mixed protocol with hMG and Urinary Follicle Stimulating Hormone (uFSH)or rFSH with conventional long GnRH agonist (eg leuprolide, etc)
  • •Each subject must be 18 to 45 years of age
  • •Use of drugs (gonadotropin, GnRH agonist or antagonist, Human Chorionic Gonadotropin \[hCG], hMG, uFSH, rFSH) must be consistent with approved label
  • •Each subject must be willing and able to provide written informed consent for the study
  • •Each subject must be able to fill the study specific questionnaires

Exclusion Criteria

  • •Subject with prior history of ovarian hyper\-stimulation syndrome (OHSS)
  • •Subject using depot formulation of GnRH agonist
  • •Subject already receiving GnRH agonist or antagonist, stimulation protocol
  • •Subject currently enrolled in another observational study or clinical trial
  • •Subject suffering from any neurological or psychiatric illness
  • •Subject has any clinically significant condition or situation, other than the condition being studied, that in the opinion of the Investigator, would interfere with the study evaluations or optimal participation in the study

Outcomes

Primary Outcomes

Not specified

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