The Effect of Melatonin Supplementation on Cumulus Cells and IVF Outcomes
NCT ID: NCT06546774
Last Updated: 2024-08-13
Study Results
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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RECRUITING
NA
200 participants
INTERVENTIONAL
2021-05-01
2025-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Melatonin group
Patients received melatonin supplementation for at least a two-month period prior to IVF cycles
Melatonin
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
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
Eligibility Criteria
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Inclusion Criteria
* BMI 18-30 kg/m2
* planning to undergo IVF cycles
Exclusion Criteria
* history of oophorectomy
* receiving oocyte donation
* Chromosome anomaly
* Congenital uterine anomaly
* Severe intrauterine adhesion
* Malignancy
* Using hormone therapy or supplements in recent 3 months
35 Years
45 Years
FEMALE
No
Sponsors
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Kaohsiung Veterans General Hospital.
OTHER
Responsible Party
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Li-Te Lin
Attending doctor, Department of Obstetrics and Gynecology, Principal Investigator, Associate professor
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
Countries
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Central Contacts
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Kuan-Hao Tsui
Role: CONTACT
Facility Contacts
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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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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KSVGH21-CT1-43
Identifier Type: -
Identifier Source: org_study_id
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