Elucidating the GREM1, HAS2 and PTGS2 Gene Expression as Oocytes Development Competency Markers Among Women With Poor Ovarian Reserve (POR) Following the in Vitro Maturation (IVM)
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 30
- Locations
- 2
- Primary Endpoint
- poor ovarian reserve
Study Overview
Brief Summary
Poor ovarian reserve (POR) is an adverse prognostic factor for In-Vitro Fertilization (IVF) success. Numerous established data showed low live birth rates per IVF cycle; 6 to 10%, including the usage of In-Vitro Maturation (IVM). In Malaysia, POR incidence increases mainly from cancer survival, endometriosis, and autoimmune diseases women; therefore, IVM implementation is paramount. In the molecular level, the low competence oocytes showed a low expression of GREM1, HAS2 and PTGS2 in human cumulus cells, thus leading to poor oocyte quality(OQ). Various IVM media had been formulated to enhance the competency and quality of the oocytes to date. Therefore, our study aims to elucidate the GREM1, HAS2 and PTGS2 gene expression as oocyte developmental competency markers among POR women following IVM and tailored to the IVF outcome.
Detailed Description
In this study, we will follow up the normal and POR women. The discarded product - cumulus cell will be used in this study for evaluation following the standard IVF cumulus-oocyte-complex denudation. We will develop the In-Vitro Model to assess the expression of GREM1, HAS2, and PTGS2 in normal and POR women first. Subsequently, these gene expressions will be reassessed again via clinical model using IVF-IVM cumulus cell comparing the both groups to elucidate the modifying of oocytes quality following IVM. The cumulus cell RNA will be extracted,and the cDNA will be synthesized and quantitated. The RT-PCR standard curves will be produced, and the concentration range of these genes will be generated and quantified. The OQ, embryo morphology scoring, fertilization rates, and live birth rates will be recorded and compared. We anticipate a higher gene expression associated with good OQ thus better fertilization and live birth rate.
Therefore, this research will understand the impact of IVM in oocytes competency, aiming to improve the fertility rate among POR women in Malaysia.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Basic Science
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 45 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •women underwent IVF with normal and Poor ovarian reserve based on the Bologna criteria( anti-Müllerian hormone (AMH) below 0.5-1.1 ng/ml]).
Exclusion Criteria
- •Male factor infertility (to reduce bias for embryo quality factor)
- •Not agree to participate.
Arms & Interventions
normal cumulus cell oocytes complex
women with normal ovarian reserve will be utilized and analyse the cumulus cell as a baseline
Intervention: cumulus cell oocytes complex (COC) among women with poor ovarian reserve (Genetic)
Outcomes
Primary Outcomes
poor ovarian reserve
Time Frame: for 1 year duration
the level of expression of Gremlin-1 (GREM1), Hyaluronic acid synthetase-2 (HAS2), and Prostaglandin-endoperoxide synthase-2 (PTGS2) in cumulus cell oocytes complex (COC) among women with poor ovarian reserve
normal ovarian reserve
Time Frame: for 1 year duration
the regulation of Gremlin-1 (GREM1), Hyaluronic acid synthetase-2 (HAS2), and Prostaglandin-endoperoxide synthase-2 (PTGS2) in normal cumulus cell oocytes complex (COC).
Secondary Outcomes
No secondary outcomes reported
Investigators
Azrai Abu
Associate Prof
National University of Malaysia