The effect of selenium and vit E supplementation on Oogenesis improvement in infertile women with occult premature ovarian insufficiency: A randomized contorolled clinical trial

Not Applicable

Recruiting

Conditions: occult premature ovarian insufficiency.
Primary ovarian failure

Registration Number: IRCT20160410027311N6

Lead Sponsor: Tabriz University of Medical Sciences

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Female

Target Recruitment: 70

Inclusion Criteria

Accepting informed written consent
Women aged 20 to 40 years old
Menstrual cycle
Having two ovaries
There is no evidence of endocrine disorders (diabetes, thyroid disorders, Addison's disease, etc.) by asking the patient and checking out the results of previous patient tests.
Occult POI (hormone AMH <1 ng / ml, reduced ovarian reserve, less than 5 anthral follicles, reduced ovarian volume to less than 2.5 cubic centimeters, or all three cases)
With BMI <30, the weight and height in this study will be measured by the researcher and the BMI will be calculated according to the formula below. BMI = (WEIGHT (kg)) / (LENGTH (m ^ 2))

Exclusion Criteria

Drug Addiction and Smoking
The tendency to use donated eggs
Having evidence of OVERT POI (FSH> 15 or amenorrhea for more than 3 months)
Supplementation of selenium and vitamin E three months before the onset of intervention
Having a history of radiotherapy and chemotherapy
The use of anticoagulants (co-administration of vitamin E with these drugs increases the risk of bleeding)

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Concentration of anti-mullerian hormone (AMH). Timepoint: Before the intervention begins and 12 months after the intervention begins. Method of measurement: To monitor the level of anti-mullerian hormone, blood sampling will be performed on the day of referral from the Brachial vein and will be immediately transferred to the laboratory and will be used with an ELISA kit.;Number of ovarian antal follicles. Timepoint: Before the intervention begins and 12 months after the intervention begins. Method of measurement: Transvaginal ultrasonography of the ovary on the third day of the menstrual cycle, performed by a radiologist and a device for all participants to check the number of antral follicles.

Secondary Outcome Measures

Name	Time	Method
Ovarian volume. Timepoint: Before the intervention begins and 12 months after the intervention begins. Method of measurement: Ovarian volume with the same ultrasound on the third day of menstruation using the following formula Ovarian volume = Length × height × width × p / 6 It will be calculated for each ovary separately.;The incidence of side effects of selenium and vitamin E and their placebo. Timepoint: After the end of the intervention. Method of measurement: The side effects of medicines will be questioned according to the checklist given during supplements or placebo and will be recorded in the checklist.