The effect of administering L-Carnitine to Clomiphene citrate stimulated cycles on ovulation and conception rate in infertile women with polycystic ovary syndrome: a randomized controlled clinical trial in Kabul.

Determination of the effect of L-Carnitine in ovulation stimulation cycles with clomiphene citrate on pregnancy and ovulation rates of infertile women with polycystic ovary syndrome in Kabul

Clinical trial with control group, with parallel group, three-blind, randomized 4-block, phase 3 on 32 samples

Sarcheshmeh complex of doctors and specialists and Kadri Khatam Al-Nabieen Hospital, Kabul

Women aged 20-35 years who visited for treatment of primary infertility due to polycystic ovary syndrome diagnosed according to Rotterdam criteria by a gynaecologist and having regular vaginal intercourse in the last year. The exclusion criteria are as follows: Infertility with other causes (such as male causes, tubular causes, etc.), allergy to L-Carnitine, pregnancy or lactation, Antimullerian hormone less than the normal range for age, having chronic diseases, the body mass index (BMI) over 30, using other antioxidants or supplements, using insulin releasing drugs, lipid-lowering agents, antiepileptic drugs, drugs with effects on endocrine system and carbohydrate metabolism from 3 months before the start of the study.

In the intervention group, L-Carnitine capsules 1000 mg from the American company called Pride Puritan's (2 capsules, 1 gr) daily with clomiphene citrate tablets,100 mg from day 3 to 9 of Menstrual cycle will be used and in the control group clomiphene will be prescribed similar to the intervention group along with an L-carnitine-like placebo capsule containing milk powder and produced by the same company in Afghanistan.

Determining luteinizing hormone (LH) levels; Determining antimullerian hormone (AMH) levels; Determining the number of antral follicles; Determining chemical pregnancy and clinical pregnancy

In the first stage, the research units will be divided into two groups of intervention and control based on the inclusion and exclusion criteria of screening and then block randomization using quadruple random blocks. This method strikes a balance in the allocated samples. In this way, we first design blocks of 4 types of available probabilities, so that in each block there are two people from the intervention group and two people from the control group. The number of probabilities in this case will be equal to 6.AABB(1)-BBAA(2)-ABBA(3)- BAAB(4)- BABA(5)- ABAB(6). Then the list of available modes is prepared and numbered by the tutor, and the statics specialist sort the blocks based on random numbers from 1 to 6. Matte envelopes in the package will be used in numbered order to hide the allocation. The researcher randomly picks up the envelopes and then enters the research units into the sampling system in order.

This study will be a phase 1 three-blind clinical trial with placebo control group. The method of blinding is that the researcher and the research units and statistical analysts will also be unaware of the type of drug used, and the placebo drug will be prepared by the pharmacist in the same form and with a special code and will be provided to the research units. Participants and researchers will be unaware of the drug codes and only the pharmacist will determine the drug code and after collecting and completing the study, these codes will be decoded.

To keep the security of data

Only part of the data, including information about the main outcome, can be shared.

Starting access period from 2023

The data will only be available to field researchers

For further research, researchers can send a written request to the responsible author

Corresponding Author, Tarbiat Modares University, Faculty of Medical Sciences, Department of Reproductive Health and Midwifery

After a written request from the responsible author, the request will be sent to the research unit of Tarbiat Modares University, and if the rules are complied with, the analyzed data will be provided to the researchers.