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GREM1, HAS2 and PTGS2 Gene Expression Following the in Vitro Maturation (IVM)

N

National University of Malaysia

Status

Enrolling

Conditions

in Vitro Maturation
Cumulus Cell
GREM1 Gene Mutation
Increased Oocyte Death

Treatments

Genetic: cumulus cell oocytes complex (COC) among women with poor ovarian reserve

Study type

Interventional

Funder types

Other

Identifiers

NCT06315777
FRGS/1/2021/SKK01/UKM/02/1

Details and patient eligibility

About

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.

Full 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.

Enrollment

30 estimated patients

Sex

Female

Ages

18 to 45 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Basic Science

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

30 participants in 1 patient group

normal cumulus cell oocytes complex
Experimental group
Description:
women with normal ovarian reserve will be utilized and analyse the cumulus cell as a baseline
Treatment:
Genetic: cumulus cell oocytes complex (COC) among women with poor ovarian reserve

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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