Infertility, Female
Conditions
Keywords
oxidative stress, antioxidants, diminished ovarian reserve
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.
Interventions
DRUGMelatonin 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.
DRUGplacebo 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.
Sponsors
Bundang CHA Hospital
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
20 Years to 40 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| IVF outcome - clinical pregnancy rate | at 6-8 weeks of gestation | presence of G-sac in the uterine cavity |
| IVF outcome - oocyte quality | 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 | 3 to 5 days after oocyte retrieval | grade the embryos& blastocysts according to the Lucinda Veeck & Gardner |
| IVF outcome -biochemical pregnancy rate | on day 12~14 after embryo transfer | serum human chorionic gonadotropin level\>10 IU |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| acquired oocyte No | 20weeks | number |
| fertilization rate | 20weeks | ratio of no. of fertilized egg/ no of total retrieved eggs |
| Comparing Pittsburgh sleep quality index | 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 |
| marker(melatonin level, receptor, 8-OHdg) in serum, follicular fluid and endometrium during IVF | 20weeks | :pg/ml units are used |
Countries
South Korea
Outcome results
None listed