Does rTMS Repetitive transcranial magnetic stimulation improve the outcome of in vitro fertilization in infertile women with moderate to severe depression
Overview
- Phase
- Phase 2/3
- Status
- Not yet recruiting
- Sponsor
- AIIMS Delhi
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Effect of rTMS on the clinical pregnancy rate in infertile women with depression undergoing IVF-Fresh ET
Overview
Brief Summary
This study is a pilot randomized, parallel group, placebo controlled trial studying the effect of rTMS (Repetitive transcranial magnetic stimulation) on the reproductive outcome in 40 infertile women with moderate to severe depression undergoing IVF cycles at ART centre, Department of Obstetrics and Gynaecology. The primary outcome measures the effect of rTMS on the clinical pregnancy rate in infertile women with depression undergoing IVF-Fresh ET cycles at 8 weeks. The secondary outcomes will be to assess depression measured using HAM-D questionnaire at 3 weeks, serum cortisol and BDNF levels at 3 weeks, oocyte and embryo quality at 6 weeks and implantation success by measuring Beta HCG level at 7 weeks.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- Participant and Investigator Blinded
Eligibility Criteria
- Ages
- 21.00 Year(s) to 35.00 Year(s) (—)
- Sex
- Female
Inclusion Criteria
- •Women undergoing IVF at ART center & willing to participate
- •Moderate to severe depression.
Exclusion Criteria
- •Comorbid psychiatric illness Substance abuse including nicotine Any other contraindication for rTMS Women with moderate to severe depression opting for pharmacotherapy Donor Recipient cycles Severe OATS (Oligoasthenoteratozoospermia) Oncofertility Hyper-responders like PCOS undergoing segmented Embryo Transfer.
Outcomes
Primary Outcomes
Effect of rTMS on the clinical pregnancy rate in infertile women with depression undergoing IVF-Fresh ET
Time Frame: 8 weeks
Secondary Outcomes
- To assess depression measured using HAM-D questionnaire pre and post rTMS(3 weeks)
- To assess the biochemical levels (Cortisol, BDNF) pre and post rTMS(3 weeks)
- Oocyte and Embryo quality(6 weeks)
- Implantation success by measuring Beta HCG levels(7 weeks)
Investigators
Dr Kataru Nikitha
AIIMS, New Delhi