Infertility, FemaleNCT03117725
Melatonin Study Between Diminished and Normal Responder in IVF
A study testing Melatonin adminstration in people with Infertility, Female, run by Bundang CHA Hospital at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Infertility, Female
- What is being tested?
- Melatonin adminstration
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteSouth Korea
- Study dates
- 12 May 2017to 31 Oct 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Infertility patients visiting Bundang CHA hospital between the age of 20 to 40.
- Currently, not being treated for any gynecological or medical diseases.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Bundang CHA medical center
Seongnam-si, Gyeonggi-do, 13496
About this study
Official title: Comparison of IVF Outcome and Endometrium Effect in Infertility Patients Between Diminished and Normal Ovarian Reserve After Melatonin Administration.
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.
Read the 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.
- Conditions
- Infertility, Female
- Being tested
- Melatonin adminstration, placebo administration
- Keywords
- oxidative stress, antioxidants, diminished ovarian reserve
- Medical subject headings
- Infertility, Female
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Melatonin adminstrationDrug
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 administrationDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| melatonin administration group | Experimental | 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. Receives: Drug: Melatonin adminstration |
| 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. Receives: Drug: placebo administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
IVF outcome - oocyte quality
Evaluate oocyte quality on morphological standard as following category- Mature oocyte, Intermediate oocyte, atretic oocyte, post mature oocyte
Measured: 3 days after oocyte retrieval
IVF outcome - embryo quality
grade the embryos\& blastocysts according to the Lucinda Veeck \& Gardner
Measured: 3 to 5 days after oocyte retrieval
IVF outcome -biochemical pregnancy rate
serum human chorionic gonadotropin level>10 IU
Measured: on day 12~14 after embryo transfer
IVF outcome - clinical pregnancy rate
presence of G-sac in the uterine cavity
Measured: at 6-8 weeks of gestation
Secondary outcomes (4)
acquired oocyte No
number
Measured: 20weeks
fertilization rate
ratio of no. of fertilized egg/ no of total retrieved eggs
Measured: 20weeks
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
Measured: 20weeks
marker(melatonin level, receptor, 8-OHdg) in serum, follicular fluid and endometrium during IVF
:pg/ml units are used
Measured: 20weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2017
- Study start12 May 2017
- Primary completion30 Aug 2019 (estimated)
- Study completion31 Oct 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Infertility, FemaleStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bundang CHA Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dong Hee Choi, Bundang CHA Hospital
- Investigators
- DONG HEE CHOI, M.D,Ph.D, Principal investigator, BUNDANGCHA HOSPITAL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03117725
- Sponsor's protocol ID
- 2016-07-013-008
- Status last verified
- Jul 2018
- First submitted
- 4 Apr 2017
- Last updated
- 13 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 25180056
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of IVF Outcome and Endometrium Effect in Infertility Patients Between Diminished and Normal Ovarian Reserve After Melatonin Administration.
- ClinicalTrials.gov ID
- NCT03117725
- Acronym / sponsor ID
- 2016-07-013-008
- Conditions
- Infertility, Female
- Keywords
- oxidative stress, antioxidants, diminished ovarian reserve
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Bundang CHA HospitalUniversity, hospital or other
- Study start
- 12 May 2017 (actual)
- Primary completion
- 30 Aug 2019 (estimated)
- Study completion
- 31 Oct 2019 (estimated)
- First posted
- 18 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| melatonin administration group | Experimental | Drug: Melatonin adminstrationTotal 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. |
| placebo comparator | Placebo comparator | Drug: placebo administrationTotal 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. |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Infertility patients visiting Bundang CHA hospital between the age of 20 to 40.
- Currently, not being treated for any gynecological or medical diseases.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Melatonin adminstrationThe 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. | Drug | melatonin administration group |
| placebo administrationthe 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. | Drug | placebo comparator |
Primary outcome
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
IVF outcome - embryo quality
Time frame: 3 to 5 days after oocyte retrieval
grade the embryos\& blastocysts according to the Lucinda Veeck \& Gardner
IVF outcome -biochemical pregnancy rate
Time frame: on day 12~14 after embryo transfer
serum human chorionic gonadotropin level>10 IU
IVF outcome - clinical pregnancy rate
Time frame: at 6-8 weeks of gestation
presence of G-sac in the uterine cavity
4 secondary outcomes
acquired oocyte No
Time frame: 20weeks
fertilization rate
Time frame: 20weeks
Comparing Pittsburgh sleep quality index
Time frame: 20weeks
marker(melatonin level, receptor, 8-OHdg) in serum, follicular fluid and endometrium during IVF
Time frame: 20weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2018.
- Background: PubMed 25180056Fernando 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
DONG HEE CHOI, M.D,Ph.D principal investigator
BUNDANGCHA HOSPITAL
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Melatonin adminstration in people with Infertility, Female, run by Bundang CHA Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
IVF outcome - oocyte quality (time frame: 3 days after oocyte retrieval). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03117725, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jul 2018.