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Polycystic ovary syndrome (PCOS) is considered as one of the most popular endocrine disorders of women at their age of reproductive and it is known as the main cause of anovulatory infertility (Joham et al., 2015). PCOS is known as a chronic systemic disease, and it is usually related to hyperandrogenemia, oxidative stress, insulin resistance and chronic inflammation (Murri et al., 2013).
In the majority of situations ovulation can be induced with clomiphene citrate which is considered one of the first-line treatments for induction of ovulation in PCOS women (Elsamy and Saleh, 2015).
L-Carnitine is a small water-soluble molecule that is obtained from the two amino acids lysine and methionine, and it has an essential duty in fat metabolism. It also has an important role in the normal mitochondrial oxidation of fatty acids, which increase the supply of energy to the cells (Latifian et al., 2015; Maldonado et al., 2016).
The aim of this study was to assess the efficacy of adding L-carnitine to clomiphene citrate for increasing the ovulation and the pregnancy rate in women with PCOS.
This study was a randomized controlled clinical trial that was conducted on 94 women who attended at the Obstetrics & Gynecology Outpatient Infertility Clinic at Ain Shams University Maternity Hospital, during the period from July 2018 to February 2019 and they were diagnosed with PCOS based on the presence of at least two of the following: oligo/anovulation, hyperandrogenism or polycystic ovaries on ultrasound (Rotterdam Criteria, 2004). All of the women were subjected to full medical history, clinical examination and trans-vaginal ultrasonography. The women were distributed randomly into two equal groups (group L and group C).
group L included 47 women that received 100 mg of clomiphene citrate plus 3 gm of L-carnitine from day 3 to day 7 of the cycle with continuation of L-carnitine till the day of pregnancy test.
group C included 47 women that received 100 mg of clomiphene citrate from day 3 to day 7 of the cycle.
Trans-vaginal folliculometry was performed on all women to monitor if at least one leading follicle attained a diameter of 17mm or more, then the endometrial thickness was measured and 10,000 IU of Human chorionic gonadotropin (hCG) was given. Timed intercourse was advised after 36 hours from the night of hCG
administration for 2 successive days. Ovulation success was confirmed by transvaginal ultrasound or measuring the Serum progesterone level after 8 days from the day of hCG injection, and ovulation was confirmed if the serum progesterone level was ≥ 5 ng/ml (Leiva et al., 2015). Luteal-phase support was not provided in both groups. Pregnancy test was done in the form of testing the level of beta hCG in the blood after 14 days once the success of the ovulation process has been confirmed.
Concerning the results, there was no significant difference between the two groups as regards to the baseline characteristics (age, BMI, duration of infertility, type of infertility) and basal hormonal profile at the third day of the cycle (P>0.05).
As regards to the primary outcome of the study which was the ovulation rate, there was a significant difference (P<0.05) between the two groups, in which group L had a higher success rate of ovulation than group C (group L: 70.2% and group C: 44.7%).
As regards to the secondary outcome of the study which was the pregnancy rate, there was no significant difference (P>0.05) between the two groups, in which group L had a pregnancy rate of 8.5% and group C had a pregnancy rate of 6.4%.
As regards to the mean number of pre-ovulatory follicles that were ≥ 17 mm in diameter, there was a highly significant difference (P<0.01) between the two groups, in which group L had more mean number of follicles than group C (group L: 1.6 ± 1.2 follicles and group C: 0.8 ± 0.7 follicles).
As regards to the mean number of days needed till hCG injection was given, there was a highly significant difference (P<0.01) between the two groups, in which group L needed less days than group C (group L: 12.2 ± 1.5 days and group C: 14.0 ± 1.8 days).
As regards to the mean Endometrial thickness at the day of hCG injection, there was a highly significant difference (P<0.01) between the two groups, in which group L had a thicker endometrium than group C (group L: 10.4 ± 1.2 mm and group C: 9.1 ± 0.8 mm).
As regards to the mean level of serum progesterone after 8 days from the hCG injection, there was no significant difference (P>0.05) between the two groups.
As regards to the side effects reported at the end of the treatment course, there was a significant difference (P<0.05) between the two groups, in which group L had more women reporting side effects than group C (group L: 19.1% and group C: 2.1%).