Melatonin Study Between Diminished and Normal Responder in IVF

Infertility, Female Clinical Trial

Official title:

Comparison of IVF Outcome and Endometrium Effect in Infertility Patients Between Diminished and Normal Ovarian Reserve After Melatonin Administration.

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT03117725
• Other study ID #: 2016-07-013-008
• Status: Enrolling by invitation
• Phase: N/A
• Start date: May 12, 2017
• Est. completion date: October 31, 2019

Study information

• Verified date: July 2018
• Source: Bundang CHA Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 100
• Est. completion date: October 31, 2019
• Est. primary completion date: August 30, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years to 40 Years

Eligibility

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.

Related Conditions & MeSH terms

• Infertility
• Infertility, Female

Intervention

Drug:
• 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.
• 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.

Locations

Country	Name	City	State
Korea, Republic of	Bundang CHA medical center	Seongnam si	Gyeonggi Do

Sponsors (1)

Lead Sponsor	Collaborator
Bundang CHA Hospital

Country where clinical trial is conducted

Korea, Republic of, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	IVF outcome - embryo quality	grade the embryos& blastocysts according to the Lucinda Veeck & Gardner	3 to 5 days after oocyte retrieval
Primary	IVF outcome -biochemical pregnancy rate	serum human chorionic gonadotropin level>10 IU	on day 12~14 after embryo transfer
Primary	IVF outcome - clinical pregnancy rate	presence of G-sac in the uterine cavity	at 6-8 weeks of gestation
Secondary	acquired oocyte No	number	20weeks
Secondary	fertilization rate	ratio of no. of fertilized egg/ no of total retrieved eggs	20weeks
Secondary	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
Secondary	marker(melatonin level, receptor, 8-OHdg) in serum, follicular fluid and endometrium during IVF	:pg/ml units are used	20weeks