Female infertility. Female infertility
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Infertile women awaiting IVF (secondary infertility) Age range from 18 to 45 years old Desire to cooperate Body mass index equal to or higher than 25 kg/m2 No recent weight loss during the previous 3 months Failure to follow a specific diet
Exclusion criteria
Exclusion criteria: Having known metabolic diseases Having known neurological disease Having major systemic diseases such as malignancies Having known liver disease Having more than 2 previous unsuccessful ART cycles Tobacco or alcohol use Having uterine or tubal disorders causing infertility Taking Antidepressants or history of diagnosis of depression during the previous one year Taking medications that affect appetite and body weight, such as corticosteroids or other supplements
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Implantation rate. Timepoint: At the end of the ART cycle. Method of measurement: ?A serum b-human chorionic gonadotropin level >6 mIU/mL, 15 to 20 days after embryo transfer.;Clinical pregnancy. Timepoint: At the end of the ART cycle. Method of measurement: The presence of at least 1 gestational sac with fetal heart activity at the sixth week of pregnancy by ultrasound. | — |
Secondary
| Measure | Time frame |
|---|---|
| Fertilization rate. Timepoint: 17 to 20 hours after insemination. Method of measurement: Number of oocytes with two-pronucleate (2PN).;Embryo formation rate. Timepoint: At the end of the intervention and within ART cycle. Method of measurement: The ratio of embryos to oocytes with two pronuclei.;Live Birth. Timepoint: Delivery after 24 week of pregnancy. Method of measurement: Neonate delivered via vaginal or cesarean section.;Depression score. Timepoint: Baseline and End-of-trial. Method of measurement: Depression Anxiety and Stress Scale-21 Questionnaire.;Anxiety score. Timepoint: Baseline and End-of-trial. Method of measurement: Depression Anxiety and Stress Scale-21 Questionnaire.;Stress score. Timepoint: Baseline and End-of-trial. Method of measurement: Depression Anxiety and Stress Scale-21 Questionnaire.;Fasting blood sugar. Timepoint: Baseline and End-of-trial. Method of measurement: Glucose oxidase assay.;LH. Timepoint: Baseline and End-of-trial. Method of measurement: Chemiluminescence immunoassay (CLIA).;FSH. Timepoint: Baseline and End-of-trial. Method of measurement: Chemiluminescence immunoassay (CLIA).;Testosterone. Timepoint: Baseline and End-of-trial. Method of measurement: Chemiluminescence immunoassay (CLIA).;Insulin. Timepoint: Baseline and End-of-trial. Method of measurement: Chemiluminescence immunoassay (CLIA).;HOMA-IR. Timepoint: Baseline and End-of-trial. Method of measurement: [Fasting Glucose (mg/dL) x Fasting Insulin (µIU/mL)] / 405.;Lipid profile including TG, HDL-C, and TC. Timepoint: Baseline and End-of-trial. Method of measurement: Biochemical Test.;Hs-CRP. Timepoint: Baseline and End-of-trial. Method of measurement: Turbidimetry test.;TAC. Timepoint: Baseline and End-of-trial. Method of measurement: ELISA.;MDA. Timepoint: Baseline and End-of-trial. Method of measurement: colorimetry.;Hirsutism. Timepoint: Baseline and End-of-trial. Method of measurement: Ferriman-Gallway scoring system.;Quality of life score. Timepoint: Baseline and | — |
Countries
Iran (Islamic Republic of)
Contacts
Kermanshah University of Medical Sciences