Clinical trial NCT06315777: GREM1, HAS2 and PTGS2 Gene Expression Following the in Vitro Maturation (IVM)
Official title: 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)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Increased Oocyte Death
in Vitro Maturation
GREM1 Gene Mutation
Cumulus Cell
Keywords: cumulus cell
GREM 1 gene expression
HAS 2 gene expression
PTGS 2 gene expression
oocyte quality
in vitro maturation
Lead sponsor: National University of Malaysia
Sponsor class: OTHER
First posted: 2024-03-18
Enrollment: 30
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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.

Eligibility criteria: 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.

Primary outcomes:
measure: normal ovarian reserve
timeFrame: for 1 year duration
measure: poor ovarian reserve
timeFrame: for 1 year duration
Secondary outcomes:
Other outcomes:
Locations:
city: Kuala Lumpur
country: Malaysia
facility: Advanced Reproductive Centre
state: Wilayah Persekutuan Kuala Lumpur
Study officials:
References:
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