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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT03117725
Other study ID # 2016-07-013-008
Secondary ID
Status Enrolling by invitation
Phase N/A
First received
Last updated
Start date May 12, 2017
Est. completion date October 31, 2019

Study information

Verified date July 2018
Source Bundang CHA Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. The investigators wish to study the relationship between unexplained, young poor ovarian responder and oxidative stress.


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.


Recruitment information / eligibility

Status Enrolling by invitation
Enrollment 100
Est. completion date October 31, 2019
Est. primary completion date August 30, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 20 Years to 40 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

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 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.

Locations

Country Name City State
Korea, Republic of Bundang CHA medical center Seongnam si Gyeonggi Do

Sponsors (1)

Lead Sponsor Collaborator
Bundang CHA Hospital

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (1)

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary IVF outcome - oocyte quality Evaluate oocyte quality on morphological standard as following category- Mature oocyte, Intermediate oocyte, atretic oocyte, post mature oocyte 3 days after oocyte retrieval
Primary IVF outcome - embryo quality grade the embryos& blastocysts according to the Lucinda Veeck & Gardner 3 to 5 days after oocyte retrieval
Primary IVF outcome -biochemical pregnancy rate serum human chorionic gonadotropin level>10 IU on day 12~14 after embryo transfer
Primary IVF outcome - clinical pregnancy rate presence of G-sac in the uterine cavity at 6-8 weeks of gestation
Secondary acquired oocyte No number 20weeks
Secondary fertilization rate ratio of no. of fertilized egg/ no of total retrieved eggs 20weeks
Secondary 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 20weeks
Secondary marker(melatonin level, receptor, 8-OHdg) in serum, follicular fluid and endometrium during IVF :pg/ml units are used 20weeks
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