Melatonin Study Between Diminished and Normal Responder in IVF

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Primary Purpose

Status

Unknown status

Phase

Not Applicable

Locations

Korea, Republic of

Study Type

Interventional

Intervention

Melatonin adminstration

placebo administration

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:

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.

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

NCT ID

NCT03117725

First Posted

April 4, 2017

Last Updated

July 11, 2018

Sponsor

Bundang CHA Hospital

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

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

Infertility, Female

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial