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Melatonin Study Between Diminished and Normal Responder in IVF

Primary Purpose

Infertility, Female

Status
Unknown status
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Melatonin adminstration
placebo administration
Sponsored by
Bundang CHA Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Infertility, Female focused on measuring oxidative stress, antioxidants, diminished ovarian reserve

Eligibility Criteria

20 Years - 40 Years (Adult)FemaleAccepts Healthy Volunteers

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.

Sites / Locations

  • Bundang CHA medical center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

melatonin administration group

placebo comparator

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

IVF outcome - oocyte quality
Evaluate oocyte quality on morphological standard as following category- Mature oocyte, Intermediate oocyte, atretic oocyte, post mature oocyte
IVF outcome - embryo quality
grade the embryos& blastocysts according to the Lucinda Veeck & Gardner
IVF outcome -biochemical pregnancy rate
serum human chorionic gonadotropin level>10 IU
IVF outcome - clinical pregnancy rate
presence of G-sac in the uterine cavity

Secondary Outcome Measures

acquired oocyte No
number
fertilization rate
ratio of no. of fertilized egg/ no of total retrieved eggs
Comparing Pittsburgh sleep quality index
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
marker(melatonin level, receptor, 8-OHdg) in serum, follicular fluid and endometrium during IVF
:pg/ml units are used

Full Information

First Posted
April 4, 2017
Last Updated
July 11, 2018
Sponsor
Bundang CHA Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03117725
Brief Title
Melatonin Study Between Diminished and Normal Responder in IVF
Official Title
Comparison of IVF Outcome and Endometrium Effect in Infertility Patients Between Diminished and Normal Ovarian Reserve After Melatonin Administration.
Study Type
Interventional

2. Study Status

Record Verification Date
July 2018
Overall Recruitment Status
Unknown status
Study Start Date
May 12, 2017 (Actual)
Primary Completion Date
August 30, 2019 (Anticipated)
Study Completion Date
October 31, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Bundang CHA Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility, Female
Keywords
oxidative stress, antioxidants, diminished ovarian reserve

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
melatonin administration group
Arm Type
Experimental
Arm Description
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.
Arm Title
placebo comparator
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Melatonin adminstration
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
placebo administration
Intervention Description
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 Measure Information:
Title
IVF outcome - oocyte quality
Description
Evaluate oocyte quality on morphological standard as following category- Mature oocyte, Intermediate oocyte, atretic oocyte, post mature oocyte
Time Frame
3 days after oocyte retrieval
Title
IVF outcome - embryo quality
Description
grade the embryos& blastocysts according to the Lucinda Veeck & Gardner
Time Frame
3 to 5 days after oocyte retrieval
Title
IVF outcome -biochemical pregnancy rate
Description
serum human chorionic gonadotropin level>10 IU
Time Frame
on day 12~14 after embryo transfer
Title
IVF outcome - clinical pregnancy rate
Description
presence of G-sac in the uterine cavity
Time Frame
at 6-8 weeks of gestation
Secondary Outcome Measure Information:
Title
acquired oocyte No
Description
number
Time Frame
20weeks
Title
fertilization rate
Description
ratio of no. of fertilized egg/ no of total retrieved eggs
Time Frame
20weeks
Title
Comparing Pittsburgh sleep quality index
Description
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
Time Frame
20weeks
Title
marker(melatonin level, receptor, 8-OHdg) in serum, follicular fluid and endometrium during IVF
Description
:pg/ml units are used
Time Frame
20weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Infertility patients visiting Bundang CHA hospital between the age of 20 to 40. Currently, not being treated for any gynecological or medical diseases. Exclusion Criteria: 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.) Currently enrolled in another interventional clinical trial. Concurrent use of other adjuvant therapies (e.g.Chinese herbs, acupuncture). Autoimmune disorders. Undergoing preimplantation genetic diagnosis. Concurrent use of any of the following medications (Fluvoxamine,Cimetidine, Quinolones, Carbamazepine, rifampicin,Zolpidem, zopiclone, and other non-benzodiazepine hypnotic, other CYP1A2 inducers. Genetic disorders regarding galactose intolerance, lactase deficiency, glucose-galactose malabsorption Inability to comply with trial protocol.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
DONG HEE CHOI, M.D,Ph.D
Organizational Affiliation
BUNDANGCHA HOSPITAL
Official's Role
Principal Investigator
Facility Information:
Facility Name
Bundang CHA medical center
City
Seongnam si
State/Province
Gyeonggi Do
ZIP/Postal Code
13496
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
25180056
Citation
Fernando S, Osianlis T, Vollenhoven B, Wallace E, Rombauts L. A pilot double-blind randomised placebo-controlled dose-response trial assessing the effects of melatonin on infertility treatment (MIART): study protocol. BMJ Open. 2014 Sep 1;4(8):e005986. doi: 10.1136/bmjopen-2014-005986.
Results Reference
background
Available IPD and Supporting Information:
Available IPD/Information Type
Study Protocol
Available IPD/Information URL
https://ezdrug.mfds.go.kr
Available IPD/Information Identifier
31098

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Melatonin Study Between Diminished and Normal Responder in IVF

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