Clinical trial NCT03117725: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Infertility, Female
Keywords: oxidative stress
antioxidants
diminished ovarian reserve
Lead sponsor: Bundang CHA Hospital
Sponsor class: OTHER
First posted: 2017-04-18
Enrollment: 100
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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.

Primary outcomes:
measure: IVF outcome - oocyte quality
timeFrame: 3 days after oocyte retrieval
measure: IVF outcome - embryo quality
timeFrame: 3 to 5 days after oocyte retrieval
measure: IVF outcome -biochemical pregnancy rate
timeFrame: on day 12~14 after embryo transfer
measure: IVF outcome - clinical pregnancy rate
timeFrame: at 6-8 weeks of gestation
Secondary outcomes:
measure: acquired oocyte No
timeFrame: 20weeks
measure: fertilization rate
timeFrame: 20weeks
measure: Comparing Pittsburgh sleep quality index
timeFrame: 20weeks
measure: marker(melatonin level, receptor, 8-OHdg) in serum, follicular fluid and endometrium during IVF
timeFrame: 20weeks
Other outcomes:
Locations:
city: Seongnam si
country: Korea, Republic of
facility: Bundang CHA medical center
state: Gyeonggi Do
Study officials:
affiliation: BUNDANGCHA HOSPITAL
name: DONG HEE CHOI, M.D,Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
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.