Melatonin Study Between Diminished and Normal Responder in IVF

NCT ID: NCT03117725

Last Updated: 2018-07-13

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-05-12
• Study Completion Date: 2019-10-31

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.

Conditions

Infertility, Female

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Study Groups

melatonin administration group

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.

Group Type: EXPERIMENTAL

Melatonin adminstration

Intervention Type: 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.

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.

Group Type: PLACEBO_COMPARATOR

placebo administration

Intervention Type: 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.

Interventions

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.

Intervention Type: DRUG

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.

Intervention Type: DRUG

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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Bundang CHA Hospital

OTHER

Sponsor Role: lead

Responsible Party

Dong Hee Choi

M.D, Ph.D

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

DONG HEE CHOI, M.D,Ph.D

Role: PRINCIPAL_INVESTIGATOR

BUNDANGCHA HOSPITAL

Locations

Bundang CHA medical center

Seongnam-si, Gyeonggi-do, South Korea

Countries

South Korea

References

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.

Reference Type: BACKGROUND

PMID: 25180056 (View on PubMed)

Study Documents

Document Type: Study Protocol

View Document

Other Identifiers

2016-07-013-008

Identifier Type: -

Identifier Source: org_study_id