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

Not Applicable

Recruiting

• Conditions: Increased Oocyte Death; in Vitro Maturation; GREM1 Gene Mutation; Cumulus Cell
• Interventions: Genetic: cumulus cell oocytes complex (COC) among women with poor ovarian reserve

• Registration Number: NCT06315777
• Lead Sponsor: National University of Malaysia

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 Timeline

• Study Start: 2021-07-01
• Status Verified: 2024-03
• Study First Submitted: 2024-03-12
• Study First Submitted QC: 2024-03-12
• Last Update Submitted: 2024-03-12
• Study First Posted: 2024-03-18
• Last Update Posted: 2024-03-18
• Primary Completion: 2024-07-01
• Study Completion: 2024-07-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 30

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
normal cumulus cell oocytes complex	cumulus cell oocytes complex (COC) among women with poor ovarian reserve	women with normal ovarian reserve will be utilized and analyse the cumulus cell as a baseline

Primary Outcome Measures

Name	Time	Method
poor ovarian reserve	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	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).

Trial Locations

Locations (1)

Advanced Reproductive Centre; 🇲🇾 Kuala Lumpur, Wilayah Persekutuan Kuala Lumpur, Malaysia