Determining the effect of alphalipoic acid on oocyte number obtained during ovulation stimulation
Design
Clinical trial with control group with parallel groups, triple-blind, randomized, phase 3 on 40 patients. For randomization, the rand function of the Excel program is used to generate a random number between 1 and 2.
Settings and conduct
Patients referring to the infertility center of Hormozgan University of Medical Sciences after confirming the diagnosis of PCO based on the Rotterdam criteria, who are candidate for in vitro fertilization, taking into the exclusion and inclusion criteria completing the informed consent form. The participants, research assistants and researchers will not know how the groups will be assigned.
Participants/Inclusion and exclusion criteria
Inclusion criteria: women with PCO according to Rotterdam criteria between 18 and 37 years old; candidate for in vitro fertilization.
Exclusion criteria: BMI greater than> 30; receiving OCPs in the last 3 months; systemic diseases; such as hyperlipidemia and cardiovascular metabolic syndrome; severe male factor, especially non-obstructive azoospermia; receive insulin.
Intervention groups
Intervention: receiving 600 mg/day of alpha lipoic acid for 2 months until the day of ovulation
Control: receiving placebo daily for 2 months
Main outcome variables
The total number of obtained oocytes; the number of MII oocytes; quality of obtained oocytes; the number of fertilized oocytes; the number of embryos that have reached the cleavage stage; the number of embryos with good quality in each cycle; chemical pregnancy rate; clinical pregnancy rate
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200905048630N4
Registration date:2023-05-24, 1402/03/03
Registration timing:prospective
Last update:2023-05-24, 1402/03/03
Update count:0
Registration date
2023-05-24, 1402/03/03
Registrant information
Name
Ensieh Salehi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 76 3333 0755
Email address
salehiensieh@hums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-09-23, 1402/07/01
Expected recruitment end date
2024-09-22, 1403/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of alpha lipoic acid administration on the outcomes of assisted reproductive therapy in patients with polycystic ovarian syndrome
Public title
The effect of alpha lipoic acid administration on the outcomes of assisted reproductive therapy in patients with polycystic ovarian syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Women with polycystic ovary syndrome according to the Rotterdam criteria
Women of reproductive age between 18 and 37 years
Candidate for in vitro fertilization
No endometriosis
Absence of hydrosalpinx
Exclusion criteria:
BMI≥30
Secondary causes of obesity (hypothyroidism, Cushing's syndrome)
High grade endometriosis III and IV
Thyroid diseases
Salpingitis and hydrosalpinx
Congenital adrenal hyperplasia
Hyperprolactinemia
Ovarian secretory tumors
Receipt of OCPs (steroids or other drugs that affect ovarian function, insulin sensitivity, and lipid metabolism) in the past 3 months, except for standardized PCOS treatment
Lupus and autoimmune diseases
Systemic diseases such as hyperlipidemia and cardiovascular metabolic syndrome
Severe male factor, especially non-obstructive azoospermia (sperm count less than 5 million/ml)
Receive insulin
Age
From 18 years old to 37 years old
Gender
Female
Phase
3
Groups that have been masked
Participant
Investigator
Data analyser
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Eligible patients (including 40 patients) are randomly assigned by a statistical expert using simple randomization method. In this method, the Random between function of the Excel program is used to generate a random number between the number 1 and 2. This work was repeated 40 times and thus a random sequence is obtained.
Blinding (investigator's opinion)
Triple blinded
Blinding description
The participants, researcher and data analyzer will not know how the groups will be assigned.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethic committee of Hormozgan University of medical sciences
Street address
Deputy of research and technology, campus of Hormozgan University of Medical Sciences, Imam Hossein boulevard, Bandar Abas, Iran