Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Melatonin adminstration | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| IVF outcome - embryo quality | grade the embryos& blastocysts according to the Lucinda Veeck & Gardner | 3 to 5 days after oocyte retrieval |
| IVF outcome -biochemical pregnancy rate | serum human chorionic gonadotropin level>10 IU | on day 12~14 after embryo transfer |
| IVF outcome - clinical pregnancy rate | presence of G-sac in the uterine cavity | at 6-8 weeks of gestation |
| Measure | Description | Time Frame |
|---|---|---|
| acquired oocyte No | number | 20weeks |
| fertilization rate | ratio of no. of fertilized egg/ no of total retrieved eggs | 20weeks |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| DONG HEE CHOI, M.D,Ph.D | BUNDANGCHA HOSPITAL | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bundang CHA medical center | Seongnam-si | Gyeonggi-do | 13496 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25180056 | Background | 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. |
Not provided
| ID | Type | URL | Comment |
|---|---|---|---|
| 31098 | Study Protocol | View IPD |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D007247 | Infertility, Female |
| ID | Term |
|---|---|
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| placebo administration | Drug | 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. |
|
| 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 |
| marker(melatonin level, receptor, 8-OHdg) in serum, follicular fluid and endometrium during IVF | :pg/ml units are used | 20weeks |
| D000091662 | Genital Diseases |
| D007246 | Infertility |