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Melatonin Study Between Diminished and Normal Responder in IVF

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ClinicalTrials.gov Identifier: NCT03117725
Recruitment Status : Enrolling by invitation
First Posted : April 18, 2017
Last Update Posted : July 13, 2018
Sponsor:
Information provided by (Responsible Party):
Dong Hee Choi, Bundang CHA Hospital

Brief Summary:
Poor sleep quality may lead to increase in oxidative stress and free radicals which in turn may decrease the reproductive function. Many researchers have already proven improvement on reproductive function after antioxidant (melatonin) administration. The investigators wish to study the relationship between unexplained, young poor ovarian responder and oxidative stress.

Condition or disease Intervention/treatment Phase
Infertility, Female Drug: Melatonin adminstration Drug: placebo administration Not Applicable

Detailed Description:

Poor sleep quality may lead to increase in oxidative stress and free radicals which in turn may decrease the reproductive function. Many researchers have already proven improvement on reproductive function after antioxidant (melatonin) administration. The investigators wish to study the relationship between unexplained, young poor ovarian responder and oxidative stress.

This is an randomized controlled trial to evaluate the effect of melatonin to improve the quality of sleep and reduce the oxidative stress. 100 patients will be randomized in to two groups, the one with melatonin administration for 2 weeks and the other with placebo administration. Each group will be composed of 2 sub groups, poor responders and normal responders.

Then the serum and the follicular fluid will be collected at the time of oocyte retrieval and melatonin concentration oxidative stress marker will be measured.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Supportive Care
Official Title: Comparison of IVF Outcome and Endometrium Effect in Infertility Patients Between Diminished and Normal Ovarian Reserve After Melatonin Administration.
Actual Study Start Date : May 12, 2017
Estimated Primary Completion Date : August 30, 2019
Estimated Study Completion Date : October 31, 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Melatonin

Arm Intervention/treatment
Experimental: melatonin administration group

Total 50 patients are to be randomized into this group, 25 of which are poor responder and the others are normal responders. After randomization, participants are to under go melatonin administration intervention from the time of controlled ovarian hyperstimulation(COH) to the date of oocyte retrieval. If pregnancy is not confirmed in the first cycle, all subjects are to enter the second cycle after 1-2 months of recovery period.

For the second cycle, the procedure will be repeated same as the first cycle with doubling of the drug dosage . It should also be administered for 2 weeks until the date of oocyte retrieval.

Drug: Melatonin adminstration
The drug, melatonin will be taken every night from the time of COH to the date of oocyte retrieval. The method of administration is as follows: Melatonin 2mg once a day, 1 to 2 hours before bedtime for about 2 weeks until the date of oocyte retrieval.

Placebo Comparator: placebo comparator

Total 50 patients are to be randomized into this group, 25 of which are poor responder and the others are normal responders. Participants for placebo comparator are advised to take the drug (placebo) from the time of COH to the date of oocyte retrieval. If pregnancy is not confirmed in the first cycle, all subjects are to enter the second cycle after 1-2 months of recovery period.

For the second cycle, the procedure will be repeated same as the first cycle with doubling of the drug dosage . It should also be administered for 2 weeks until the date of oocyte retrieval.

Drug: placebo administration
the drug, placebo pill will be taken every night from the time of COH to the date of oocyte retrieval. The method of administration is as follows: placebo pill once a day, 1 to 2 hours before bedtime for about 2 weeks until the date of oocyte retrieval.




Primary Outcome Measures :
  1. IVF outcome - oocyte quality [ Time Frame: 3 days after oocyte retrieval ]
    Evaluate oocyte quality on morphological standard as following category- Mature oocyte, Intermediate oocyte, atretic oocyte, post mature oocyte

  2. IVF outcome - embryo quality [ Time Frame: 3 to 5 days after oocyte retrieval ]
    grade the embryos& blastocysts according to the Lucinda Veeck & Gardner

  3. IVF outcome -biochemical pregnancy rate [ Time Frame: on day 12~14 after embryo transfer ]
    serum human chorionic gonadotropin level>10 IU

  4. IVF outcome - clinical pregnancy rate [ Time Frame: at 6-8 weeks of gestation ]
    presence of G-sac in the uterine cavity


Secondary Outcome Measures :
  1. acquired oocyte No [ Time Frame: 20weeks ]
    number

  2. fertilization rate [ Time Frame: 20weeks ]
    ratio of no. of fertilized egg/ no of total retrieved eggs

  3. Comparing Pittsburgh sleep quality index [ Time Frame: 20weeks ]
    questionaires to evaluate the participants quality of the sleep. cut off : 13 points This questionaire is to be asked to the participants twice, before and after the administration of the drug

  4. marker(melatonin level, receptor, 8-OHdg) in serum, follicular fluid and endometrium during IVF [ Time Frame: 20weeks ]
    :pg/ml units are used



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Ages Eligible for Study:   20 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Infertility patients visiting Bundang CHA hospital between the age of 20 to 40.
  2. Currently, not being treated for any gynecological or medical diseases.

Exclusion Criteria:

  1. Current untreated pelvic pathology (moderate-to-severe endometriosis, submucosal uterine fibroids/polyps assessed by the treating specialist to affect fertility, pelvic inflammatory disease,uterine malformations, and hydrosalpinx.)
  2. Currently enrolled in another interventional clinical trial.
  3. Concurrent use of other adjuvant therapies (e.g.Chinese herbs, acupuncture).
  4. Autoimmune disorders.
  5. Undergoing preimplantation genetic diagnosis.
  6. Concurrent use of any of the following medications (Fluvoxamine,Cimetidine, Quinolones, Carbamazepine, rifampicin,Zolpidem, zopiclone, and other non-benzodiazepine hypnotic, other CYP1A2 inducers.
  7. Genetic disorders regarding galactose intolerance, lactase deficiency, glucose-galactose malabsorption
  8. Inability to comply with trial protocol.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03117725


Locations
Korea, Republic of
Bundang CHA medical center
Seongnam si, Gyeonggi Do, Korea, Republic of, 13496
Sponsors and Collaborators
Bundang CHA Hospital
Investigators
Principal Investigator: DONG HEE CHOI, M.D,Ph.D BUNDANGCHA HOSPITAL

Study Data/Documents: Study Protocol  This link exits the ClinicalTrials.gov site
Identifier: 31098

Publications:
Responsible Party: Dong Hee Choi, M.D, Ph.D, Bundang CHA Hospital
ClinicalTrials.gov Identifier: NCT03117725     History of Changes
Other Study ID Numbers: 2016-07-013-008
First Posted: April 18, 2017    Key Record Dates
Last Update Posted: July 13, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Dong Hee Choi, Bundang CHA Hospital:
oxidative stress
antioxidants
diminished ovarian reserve

Additional relevant MeSH terms:
Infertility
Infertility, Female
Genital Diseases, Male
Genital Diseases, Female
Melatonin
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Central Nervous System Depressants