A questionnaire based study to understand the psychological and physical effects or burden a woman has to undergo during an infertility treatment
- Conditions
- Health Condition 1: null- Women between the age of 18-45 diagnosed or being treated for Infertility
- Registration Number
- CTRI/2012/07/002770
- Lead Sponsor
- Organon India Pvt Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 669
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
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
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change in psychological burden (anxiety depression) compared between two groups using HAD scale <br/ ><br>Change in physical burden by comparison of score using HSCL scale, between the two groups <br/ ><br>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 <br/ ><br>Timepoint: Antagnist - Day 0, day 10, Day 24 <br/ ><br> <br/ ><br>Agonist Day 0, Day of hCG and 14 days post hCG
- Secondary Outcome Measures
Name Time Method 1.Number of patients with at least one adverse event will be compared between the two groups <br/ ><br>2.Incidence of OHSS will be compared between the two groups <br/ ><br>Timepoint: Day 14-16 after hCG