Study the effect of Dehydroepiandrosterone on the ovarian reserve rates and serum anti-Mullerian hormone levels in infertile women with diminished ovarian reserve.
Objective: To assess the effect of Dehydroepiandrosterone (DHEA) on ovarian reserve including serum anti-Müllerian hormone (AMH) levels in infertile women with diminished ovarian reserve. Study design: Randomized, not blind, double center, phase 2. Setting and conduct: seventy infertile women with diminished ovarian reserve divided in two groups of 35 based on randomized number table. Patients and physician became aware and informed from intervention. Inclusion criteria: Women aged 20 to 45 years; normal hysterosalpingography; AMH levels < 1.5 ng/ml; antral follicular counts (AFC) < 7 in both ovaries; prior less than three failed in vitro fertilization cycles. Exclusion criteria: Normal ovarian response in ovulatory cycles or in vitro fertilization cycles. Sample size: 70 Intervention: Pretreatment with DHEA supplementation. Intervention time: Six weeks prior to in vitro fertilization cycles. Primary outcome (s): AMH levels changes; Clinical pregnancy rates. Secondary outcome(s): Miscarriage rates, antral follicular counts changes.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017091529374N1
Registration date:2017-09-15, 1396/06/24
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-09-15, 1396/06/24
Registrant information
Name
Marzieh Zamaniyan
Name of organization / entity
Mazandaran University of Medical Sciences, Sari, Iran.
Country
Iran (Islamic Republic of)
Phone
+98 11 3336 5724
Email address
m.zamanian@mazums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Mazandaran University of Medical Science.
Expected recruitment start date
2017-05-27, 1396/03/06
Expected recruitment end date
2018-02-19, 1396/11/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Study the effect of Dehydroepiandrosterone on the ovarian reserve rates and serum anti-Mullerian hormone levels in infertile women with diminished ovarian reserve.
Public title
Effects of Dehydroepiandrosterone on ovary.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Infertile women aged 20 to 45 years; normal hysterosalpingography; AMH levels < 1.5 ng/ml; antral follicular counts (AFC) < 7 in both ovaries; prior less than three failed in vitro fertilization cycles. Exclusion criteria: Normal ovarian response in ovulatory cycles or in vitro fertilization cycles.
Age
From 20 years old to 45 years old
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Mazandaran University of Medical Science.
Street address
240 Plaque, Third floor, Mazandaran University of Medical Sciences, Joybar street, Sari, Iran
City
Sari
Postal code
4815659769
Approval date
2017-05-27, 1396/03/06
Ethics committee reference number
IR.MAZUMS.IMAMHOSPITAL.REC.96.2806
Health conditions studied
1
Description of health condition studied
Diseases of the genitourinary system
ICD-10 code
N97; N98
ICD-10 code description
Female infertility; Complications associated with artificial fertilization
Primary outcomes
1
Description
Anti-mullerian hormone rate
Timepoint
Before intervention, six weeks after intervention
Method of measurement
Laboratory kits
2
Description
Clinical pregnancy rates
Timepoint
Forth weeks after embryo transfer
Method of measurement
Questionnare
Secondary outcomes
1
Description
Miscarriage rates
Timepoint
Till twenty weeks after embryo transfer
Method of measurement
File
2
Description
Antral Follicular counts
Timepoint
Before treatment, six weeks after treatments
Method of measurement
ultrasonography
Intervention groups
1
Description
Intervention group: Use of Dehydroepiandrosterone tablet, 25 mg three times a day till 6 weeks.