The steroid profile of follicular fluid in In Vitro Fertilization (IVF) treatment cycles with a standard controlled ovarian stimulation GnRH antagonist regimen and with adjuvant of Letrozole among women with polycystic ovary syndrome and non-PCOS, and its relationship with oocyte number, quality, fertilization rate and implantation rate.
NRC Grant No: 17-086
Research Institute: University of Kelaniya
Area of Research: Infertility, Assisted Reproduction
Summary
Study design: Comparative interventional study with one control group and 3 study arms.
Study setting: Infertility treatment unit of Colombo North Teaching Hospital
Study population: Women with tubal or unexplained infertility and those with PCOS undergoing IVF treatment.
Definition of intervention: Addition of Letrozole 5mg for 5 days starting from the second day of a menstrual cycle to the ovarian stimulation protocol while a placebo tablet would be used in the other group.
Definition of primary outcome: The steroid hormone composition of follicular fluid and the oocyte quantity, quality, fertilisation rate, implantation rate and pregnancy rate.
Sample size: 40 subjects with 20 in groups either receiving or not receiving the adjuvant.
Therefore 10 subjects will be included in each study arm. Proposed data analysis: Data analysis will be done to compare the two study groups with regard to total drug used, the number and quality of oocytes and the hormone profile in the follicle fluid. The student t-test (if the data is normally distributed) or Mann-Whitney U test using median and terquartile intervals (if skewed) will be used for comparisons and a statistical significance of 5% would be used for all analysis.
Main ethical issues: No major ethical issues have been identified in this study. The study interventions have not raised any significant concerns in previous studies. The study does not require the women to have any additional visits or nterventions for study purpose.
There will be no payments to the study participants since the study does not require any additional clinic visits or investigations. The complete treatment cycle would be carried out free of charge for study participants.
Objectives
- To describe the follicular fluid composition (progesterone, oestradiol, testosterone and DHEAS levels) in women with normal ovarian function undergoing controlled ovarian stimulation for IVF
- To compare the follicle fluid composition among women with PCOS undergoing COS for IVF with that of women with normal ovarian function
- To describe the changes in follicular fluid composition with addition of letrozole as an adjuvant to COS among PCOS and non-PCOS women undergoing IVF
- To describe the association between follicular fluid steroid composition and oocyte quality, fertilisation rate, implantation rate and pregnancy rate in PCOS and non-PCOS women undergoing IVF
- To compare the total FSH used in a treatment cycle where letrozole is added as an adjuvant, to that of a treatment cycle using FSH alone among PCOS and non-PCOS women undergoing IVF
- To compare the oocyte number between women who undergo ovarian stimulation with FSH alone and with FSH and letrozole in a combination among PCOS and non- PCOS women
- To study other parameters within the follicular fluid such as the proteomic composition, the cellular composition and free mRNA composition that can be used as prognostic indicators of oocyte quality and function