Melatonin Study Between Diminished and Normal Responder in IVF

NCT03117725 | Unknown

• 1 other identifier: 2016-07-013-008
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Infertility, Female

Keywords

oxidative stress; antioxidants; diminished ovarian reserve

Outcome Measures

Primary Outcomes (4)

• 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

Secondary Outcomes (4)

• acquired oocyte No

  20weeks

• fertilization rate

  20weeks

• Comparing Pittsburgh sleep quality index

  20weeks

• marker(melatonin level, receptor, 8-OHdg) in serum, follicular fluid and endometrium during IVF

  20weeks

Study Arms (2)

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.

Drug: Melatonin adminstration

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.

Drug: placebo administration

Interventions

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.

melatonin administration group

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.

placebo comparator

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Infertility patients visiting Bundang CHA hospital between the age of 20 to 40.
• Currently, not being treated for any gynecological or medical diseases.

You may not qualify if:

• 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.)
• Currently enrolled in another interventional clinical trial.
• Concurrent use of other adjuvant therapies (e.g.Chinese herbs, acupuncture).
• Autoimmune disorders.
• Undergoing preimplantation genetic diagnosis.
• Concurrent use of any of the following medications (Fluvoxamine,Cimetidine, Quinolones, Carbamazepine, rifampicin,Zolpidem, zopiclone, and other non-benzodiazepine hypnotic, other CYP1A2 inducers.
• Genetic disorders regarding galactose intolerance, lactase deficiency, glucose-galactose malabsorption
• Inability to comply with trial protocol.

Sponsors & Collaborators

• Bundang CHA Hospital: lead

Study Sites (1)

Bundang CHA medical center

Seongnam-si, Gyeonggi-do, 13496, South Korea

Location

Related 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.

  PMID: 25180056 BACKGROUND

MeSH Terms

Conditions

Infertility, Female

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Infertility

Study Officials

• DONG HEE CHOI, M.D,Ph.D

  BUNDANGCHA HOSPITAL

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D, Ph.D

Study Record Dates

• First Submitted: April 4, 2017
• First Posted: April 18, 2017
• Study Start: May 12, 2017
• Primary Completion: August 30, 2019
• Study Completion: October 31, 2019
• Last Updated: July 13, 2018

Record last verified: 2018-07

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)