The Effect of Melatonin Supplementation on Cumulus Cells and IVF Outcomes

NCT ID: NCT06546774

Last Updated: 2024-08-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-05-01

Study Completion Date

2025-12-31

Brief Summary

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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.

Detailed Description

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Aging in female reproductive cells, particularly cumulus granulosa cells, is associated with various dysfunctions that compromise fertility. Melatonin, a hormone primarily produced by the pineal gland, is renowned for its multifaceted roles in regulating physiological processes, including sleep-wake cycles, immune function, and antioxidative defense. Melatonin's antioxidant action is mediated through direct scavenging of free radicals, upregulation of antioxidant enzymes, and improvement of mitochondrial efficiency. These properties make melatonin a promising candidate for mitigating the adverse effects of aging on cellular function. This study aims to explore 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. In the control group, patients will proceed directly to IVF cycles without melatonin supplementation. Cumulus cells will be collected after oocyte retrieval, and gene expression will be measured. Additionally, clinical pregnancy rate, live birth rate, and miscarriage rate between the two groups will be evaluated.

Conditions

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Unrecognized Condition

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Melatonin group

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

Group Type EXPERIMENTAL

Melatonin

Intervention Type DIETARY_SUPPLEMENT

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

Control group

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Melatonin

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

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* 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
Minimum Eligible Age

35 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Kaohsiung Veterans General Hospital.

OTHER

Sponsor Role lead

Responsible Party

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Li-Te Lin

Attending doctor, Department of Obstetrics and Gynecology, Principal Investigator, Associate professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Kuan-Hao Tsui

Role: STUDY_DIRECTOR

Kaohsiung Veterans General Hospital.

Locations

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

Kaohsiung City, , Taiwan

Site Status RECRUITING

Countries

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Taiwan

Central Contacts

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Li-Te Lin

Role: CONTACT

+88673464027

Kuan-Hao Tsui

Role: CONTACT

Facility Contacts

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Kuan-Hao Tsui

Role: primary

+886-7-3422121

References

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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.

Reference Type RESULT
PMID: 38580962 (View on PubMed)

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.

Reference Type RESULT
PMID: 37794412 (View on PubMed)

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.

Reference Type RESULT
PMID: 27314334 (View on PubMed)

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.

Reference Type RESULT
PMID: 29186876 (View on PubMed)

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.

Reference Type RESULT
PMID: 28833478 (View on PubMed)

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.

Reference Type RESULT
PMID: 28137755 (View on PubMed)

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.

Reference Type RESULT
PMID: 29112712 (View on PubMed)

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.

Reference Type RESULT
PMID: 28178360 (View on PubMed)

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.

Reference Type RESULT
PMID: 23737216 (View on PubMed)

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.

Reference Type RESULT
PMID: 35634513 (View on PubMed)

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.

Reference Type RESULT
PMID: 24628045 (View on PubMed)

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.

Reference Type RESULT
PMID: 21748445 (View on PubMed)

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.

Reference Type RESULT
PMID: 21770829 (View on PubMed)

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.

Reference Type RESULT
PMID: 28293053 (View on PubMed)

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.

Reference Type RESULT
PMID: 32292388 (View on PubMed)

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.

Reference Type RESULT
PMID: 34494508 (View on PubMed)

Other Identifiers

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KSVGH21-CT1-43

Identifier Type: -

Identifier Source: org_study_id

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