Evidence of Good Glycemic control in Conceptions through Assisted Reproduction Technology [EGG CART Study]
Not Applicable
Completed
- Conditions
- Health Condition 1: null- Women with Prediabetes and Diabetes prior to conception through Assisted Reproduction Technology
- Registration Number
- CTRI/2008/091/000179
- Lead Sponsor
- DrSNallaperumal
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 300
Inclusion Criteria
Age up to 45 years, failure to conceive after at least 1 year of unprotected sex, Use of self or donor egg for fertilization, Both IVF naive and repeaters [up to 4 attempts], OGTT normal for normoglycemic arm, OGTT [FBS 101 to 125 mg/dl, 2 hour PPBS 141 to 199 mg/dl] for prediabetic arm, OGTT [FBS > 126 mg/dl, 2 hour PPBS > 200 mg/dl] for diabetics
Exclusion Criteria
Male factor infertility [Azoospermia], Impaired fertility caused by endocrine dysfunction other than diabetes mellitus, Smokers, Alcohol and other illicit drug abusers, other medical conditions which contraindicate treatment with Assisted Reproduction Technology
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Adverse pregnancy outcomes (congenital abnormalities, Neonatal Hypoglycemia, <br/ ><br>LGA, SGA, Spontaneous abortions, Stillbirth, neonatal death) in diabetic and prediabetic womenTimepoint: Neonatal Hypoglycemia - From birth to 48 hours. All other outcomes at the time of delivery
- Secondary Outcome Measures
Name Time Method Conception rateTimepoint: 10 weeks from the date of embryo transfer [excludes biochemical pregnancy]