The Effect of Melatonin Supplementation on Cumulus Cells and IVF Outcomes

NCT06546774 | Recruiting

• 1 other identifier: KSVGH21-CT1-43
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

This study investigates the effects of melatonin supplementation on cumulus cell gene expression and in vitro fertilization (IVF) outcomes in women over 35 years old. In the study group, patients will receive melatonin supplementation for at least two months prior to their IVF cycles. Cumulus cells will be collected after oocyte retrieval, and IVF outcomes will be assessed.

Conditions

Unrecognized Condition

Keywords

Melatonin; Cumulus cells; In vitro fertilization; Old women; Infertility

Outcome Measures

Primary Outcomes (3)

• Live birth rate (%)

  a viable infant after 24 weeks of gestation

  through study completion, an average of 4 year

• oxygen consumption rate of mitochodria (%)

  to assess mitocondrial function in cumulus cells

  through study completion, an average of 4 year

• mRNA levels of cumulus cell genes

  to assess cumulus cells gene expression analysis

  through study completion, an average of 4 year

Secondary Outcomes (3)

• Clinical pregnancy rate (%)

  through study completion, an average of 4 year

• Ongoing pregnancy rate (%)

  through study completion, an average of 4 year

• Amount of ATP production (moles/min) of mitochodria

  through study completion, an average of 4 year

Study Arms (2)

Melatonin group

EXPERIMENTAL

Patients received melatonin supplementation for at least a two-month period prior to IVF cycles

Dietary Supplement: Melatonin

Control group

NO INTERVENTION

Patients did not receive melatonin supplementation and proceeded directly to IVF cycles

Interventions

Melatonin DIETARY_SUPPLEMENT

In the study group, patients will receive melatonin supplementation for at least two months prior to IVF cycles

Melatonin group

Eligibility Criteria

• Age: 35 Years - 45 Years
• Gender Eligibility Details: Infertile women planning to undergo IVF cycles
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Age 35-45 years
• BMI 18-30 kg/m2
• planning to undergo IVF cycles

You may not qualify if:

• Primary ovarian insufficiency
• history of oophorectomy
• receiving oocyte donation
• Chromosome anomaly
• Congenital uterine anomaly
• Severe intrauterine adhesion
• Malignancy
• Using hormone therapy or supplements in recent 3 months

Sponsors & Collaborators

• Kaohsiung Veterans General Hospital.: lead

Study Sites (1)

Department of Obstetrics and Gynecology, Kaohsiung Veterans General Hospital, Kaohsiung, Taiwan

Kaohsiung City, 886, Taiwan

RECRUITING

Related Publications (16)

• Kandil OM, Rahman SMAE, Ali RS, Ismail EA, Ibrahim NM. Effect of melatonin on developmental competence, mitochondrial distribution, and intensity of fresh and vitrified/thawed in vitro matured buffalo oocytes. Reprod Biol Endocrinol. 2024 Apr 5;22(1):39. doi: 10.1186/s12958-024-01209-7.

  PMID: 38580962 RESULT

• Navid S, Saadatian Z, Talebi A. Assessment of developmental rate of mouse embryos yielded from in vitro fertilization of the oocyte with treatment of melatonin and vitamin C simultaneously. BMC Womens Health. 2023 Oct 4;23(1):525. doi: 10.1186/s12905-023-02673-w.

  PMID: 37794412 RESULT

• He C, Wang J, Zhang Z, Yang M, Li Y, Tian X, Ma T, Tao J, Zhu K, Song Y, Ji P, Liu G. Mitochondria Synthesize Melatonin to Ameliorate Its Function and Improve Mice Oocyte's Quality under in Vitro Conditions. Int J Mol Sci. 2016 Jun 14;17(6):939. doi: 10.3390/ijms17060939.

  PMID: 27314334 RESULT

• Yang M, Tao J, Chai M, Wu H, Wang J, Li G, He C, Xie L, Ji P, Dai Y, Yang L, Liu G. Melatonin Improves the Quality of Inferior Bovine Oocytes and Promoted Their Subsequent IVF Embryo Development: Mechanisms and Results. Molecules. 2017 Nov 27;22(12):2059. doi: 10.3390/molecules22122059.

  PMID: 29186876 RESULT

• Zhao XM, Wang N, Hao HS, Li CY, Zhao YH, Yan CL, Wang HY, Du WH, Wang D, Liu Y, Pang YW, Zhu HB. Melatonin improves the fertilization capacity and developmental ability of bovine oocytes by regulating cytoplasmic maturation events. J Pineal Res. 2018 Jan;64(1). doi: 10.1111/jpi.12445. Epub 2017 Oct 11.

  PMID: 28833478 RESULT

• Dai X, Lu Y, Zhang M, Miao Y, Zhou C, Cui Z, Xiong B. Melatonin improves the fertilization ability of post-ovulatory aged mouse oocytes by stabilizing ovastacin and Juno to promote sperm binding and fusion. Hum Reprod. 2017 Mar 1;32(3):598-606. doi: 10.1093/humrep/dew362.

  PMID: 28137755 RESULT

• Miao Y, Zhou C, Bai Q, Cui Z, ShiYang X, Lu Y, Zhang M, Dai X, Xiong B. The protective role of melatonin in porcine oocyte meiotic failure caused by the exposure to benzo(a)pyrene. Hum Reprod. 2018 Jan 1;33(1):116-127. doi: 10.1093/humrep/dex331.

  PMID: 29112712 RESULT

• Zhang M, Dai X, Lu Y, Miao Y, Zhou C, Cui Z, Liu H, Xiong B. Melatonin protects oocyte quality from Bisphenol A-induced deterioration in the mouse. J Pineal Res. 2017 Apr;62(3). doi: 10.1111/jpi.12396. Epub 2017 Mar 1.

  PMID: 28178360 RESULT

• Wei D, Zhang C, Xie J, Song X, Yin B, Liu Q, Hu L, Hao H, Geng J, Wang P. Supplementation with low concentrations of melatonin improves nuclear maturation of human oocytes in vitro. J Assist Reprod Genet. 2013 Jul;30(7):933-8. doi: 10.1007/s10815-013-0021-2. Epub 2013 Jun 6.

  PMID: 23737216 RESULT

• Bao Z, Li G, Wang R, Xue S, Zeng Y, Deng S. Melatonin Improves Quality of Repeated-Poor and Frozen-Thawed Embryos in Human, a Prospective Clinical Trial. Front Endocrinol (Lausanne). 2022 May 13;13:853999. doi: 10.3389/fendo.2022.853999. eCollection 2022.

  PMID: 35634513 RESULT

• Nishihara T, Hashimoto S, Ito K, Nakaoka Y, Matsumoto K, Hosoi Y, Morimoto Y. Oral melatonin supplementation improves oocyte and embryo quality in women undergoing in vitro fertilization-embryo transfer. Gynecol Endocrinol. 2014 May;30(5):359-62. doi: 10.3109/09513590.2013.879856. Epub 2014 Mar 17.

  PMID: 24628045 RESULT

• Eryilmaz OG, Devran A, Sarikaya E, Aksakal FN, Mollamahmutoglu L, Cicek N. Melatonin improves the oocyte and the embryo in IVF patients with sleep disturbances, but does not improve the sleeping problems. J Assist Reprod Genet. 2011 Sep;28(9):815-20. doi: 10.1007/s10815-011-9604-y. Epub 2011 Jul 12.

  PMID: 21748445 RESULT

• Batioglu AS, Sahin U, Gurlek B, Ozturk N, Unsal E. The efficacy of melatonin administration on oocyte quality. Gynecol Endocrinol. 2012 Feb;28(2):91-3. doi: 10.3109/09513590.2011.589925. Epub 2011 Jul 20.

  PMID: 21770829 RESULT

• Jahromi BN, Sadeghi S, Alipour S, Parsanezhad ME, Alamdarloo SM. Effect of Melatonin on the Outcome of Assisted Reproductive Technique Cycles in Women with Diminished Ovarian Reserve: A Double-Blinded Randomized Clinical Trial. Iran J Med Sci. 2017 Jan;42(1):73-78.

  PMID: 28293053 RESULT

• Hu KL, Ye X, Wang S, Zhang D. Melatonin Application in Assisted Reproductive Technology: A Systematic Review and Meta-Analysis of Randomized Trials. Front Endocrinol (Lausanne). 2020 Mar 27;11:160. doi: 10.3389/fendo.2020.00160. eCollection 2020.

  PMID: 32292388 RESULT

• Mejlhede MAB, Jepsen JB, Knudsen UB. Oral melatonin supplementation during in vitro fertilization treatment: a systematic PRISMA review and meta-analysis of randomized controlled trials. Gynecol Endocrinol. 2021 Dec;37(12):1079-1085. doi: 10.1080/09513590.2021.1974378. Epub 2021 Sep 8.

  PMID: 34494508 RESULT

MeSH Terms

Conditions

Infertility

Interventions

Melatonin

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Tryptamines; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

• Kuan-Hao Tsui

  Kaohsiung Veterans General Hospital.

  STUDY DIRECTOR

Central Study Contacts

Li-Te Lin

CONTACT

+88673464027; litelin1982@gmail.com

Kuan-Hao Tsui

CONTACT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending doctor, Department of Obstetrics and Gynecology, Principal Investigator, Associate professor

Study Record Dates

• First Submitted: August 1, 2024
• First Posted: August 9, 2024
• Study Start: May 1, 2021
• Primary Completion: October 31, 2025
• Study Completion: December 31, 2025
• Last Updated: August 13, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)