Health Condition 1: null- Women between the age of 18-45 diagnosed or being treated for Infertility
Conditions
Interventions
None listed
Sponsors
Organon India Pvt Limited
Eligibility
Inclusion 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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in psychological burden (anxiety depression) compared between two groups using HAD scale Change in physical burden by comparison of score using HSCL scale, between the two groups Psychological burden and wellbeing and impact of medication by comparison of scores using COSI questionnaire between the two groups at the end of GnRH agonist or antagonist administration Timepoint: Antagnist - Day 0, day 10, Day 24 Agonist Day 0, Day of hCG and 14 days post hCG | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Number of patients with at least one adverse event will be compared between the two groups 2. Incidence of OHSS will be compared between the two groups Timepoint: Day 14-16 after hCG | — |
Countries
India
Contacts
Public ContactDrSwashraya Shah
MSD Pharmaceuticals India
Outcome results
None listed