NCT06315777

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2021

Completed
2.7 years until next milestone

First Submitted

Initial submission to the registry

March 12, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 18, 2024

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2024

Completed
Last Updated

March 18, 2024

Status Verified

March 1, 2024

Enrollment Period

3 years

First QC Date

March 12, 2024

Last Update Submit

March 12, 2024

Conditions

Keywords

cumulus cellGREM 1 gene expressionHAS 2 gene expressionPTGS 2 gene expressionoocyte qualityin vitro maturation

Outcome Measures

Primary Outcomes (2)

  • normal ovarian reserve

    the regulation of Gremlin-1 (GREM1), Hyaluronic acid synthetase-2 (HAS2), and Prostaglandin-endoperoxide synthase-2 (PTGS2) in normal cumulus cell oocytes complex (COC).

    for 1 year duration

  • poor ovarian reserve

    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

    for 1 year duration

Study Arms (1)

normal cumulus cell oocytes complex

EXPERIMENTAL

women with normal ovarian reserve will be utilized and analyse the cumulus cell as a baseline

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

Interventions

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 were analyzed

normal cumulus cell oocytes complex

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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\]).

You may not qualify if:

  • Male factor infertility (to reduce bias for embryo quality factor)
  • Not agree to participate.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Advanced Reproductive Centre

Kuala Lumpur, Kuala Lumpur, 56000, Malaysia

RECRUITING

Related Publications (6)

  • Rouhollahi Varnosfaderani S, Hajian M, Jafarpour F, Ghazvini Zadegan F, Nasr-Esfahani MH. Granulosa secreted factors improve the developmental competence of cumulus oocyte complexes from small antral follicles in sheep. PLoS One. 2020 Mar 17;15(3):e0229043. doi: 10.1371/journal.pone.0229043. eCollection 2020.

  • Anderson RA, Sciorio R, Kinnell H, Bayne RA, Thong KJ, de Sousa PA, Pickering S. Cumulus gene expression as a predictor of human oocyte fertilisation, embryo development and competence to establish a pregnancy. Reproduction. 2009 Oct;138(4):629-37. doi: 10.1530/REP-09-0144. Epub 2009 Jul 14.

  • McKenzie LJ, Pangas SA, Carson SA, Kovanci E, Cisneros P, Buster JE, Amato P, Matzuk MM. Human cumulus granulosa cell gene expression: a predictor of fertilization and embryo selection in women undergoing IVF. Hum Reprod. 2004 Dec;19(12):2869-74. doi: 10.1093/humrep/deh535. Epub 2004 Oct 7.

  • Russell DL, Robker RL. Molecular mechanisms of ovulation: co-ordination through the cumulus complex. Hum Reprod Update. 2007 May-Jun;13(3):289-312. doi: 10.1093/humupd/dml062. Epub 2007 Jan 22.

  • Demiray SB, Goker ENT, Tavmergen E, Yilmaz O, Calimlioglu N, Soykam HO, Oktem G, Sezerman U. Differential gene expression analysis of human cumulus cells. Clin Exp Reprod Med. 2019 Jun;46(2):76-86. doi: 10.5653/cerm.2019.46.2.76. Epub 2019 Jun 1.

  • Karakaya C, Guzeloglu-Kayisli O, Uyar A, Kallen AN, Babayev E, Bozkurt N, Unsal E, Karabacak O, Seli E. Poor ovarian response in women undergoing in vitro fertilization is associated with altered microRNA expression in cumulus cells. Fertil Steril. 2015 Jun;103(6):1469-76.e1-3. doi: 10.1016/j.fertnstert.2015.02.035. Epub 2015 Apr 22.

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Prof

Study Record Dates

First Submitted

March 12, 2024

First Posted

March 18, 2024

Study Start

July 1, 2021

Primary Completion

July 1, 2024

Study Completion

July 31, 2024

Last Updated

March 18, 2024

Record last verified: 2024-03

Locations