The adjuvant effect of metformin and N-acetylcysteine to clomiphene citrate in induction of ovulation and pregnancy rate in patients with Polycystic Ovary Syndrome

• Register: ANZCTR
• Last refreshed on: 13 January 2020
• Main ID: ACTRN12614000697684
• Date of registration: 02/07/2014
• Prospective Registration: No
• Primary sponsor: Ahmed Maged
• Public title: The adjuvant effect of metformin and N-acetylcysteine to clomiphene citrate in induction of ovulation and pregnancy rate in patients with Polycystic Ovary Syndrome
• Scientific title: The adjuvant effect of metformin and N-acetylcysteine to clomiphene citrate in induction of ovulation and pregnancy rate in patients with Polycystic Ovary Syndrome.
• Date of first enrolment: 01/09/2012
• Target sample size: 120
• Recruitment status: Completed
• URL: https://anzctr.org.au/ACTRN12614000697684.aspx
• Study type: Interventional
• Study design: Purpose: Treatment; Allocation: Randomised controlled trial; Masking: Open (masking not used);Type of endpoint: Efficacy;
• Phase: Phase 4

Countries of recruitment

Egypt

Contacts

• Name: A/Prof Ahmed Maged

• Name: A/Prof Ahmed Maged

Key inclusion & exclusion criteria

Inclusion criteria: women with PCOS trying to fall pregnant
Exclusion criteria: 1. women with endocrinological abnormalities as thyroid dysfunction or abnormal prolactin levels
2. women with hypothalamic or pituitary dysfunctions
3. women with other causes of infertility as tubal factor, abnormal uterine cavity and male factor evaluated.
4.Women with ovarian cysts
5.women with allergy to used medications.
6. Patients who had received any hormonal medications (except progesterone for withdrawal bleeding) for at least 3 months before the study.

Age minimum: 19 Years
Age maximum: 35 Years
Gender: Females

Health Condition(s) or Problem(s) studied

Reproductive Health and Childbirth - Fertility including in vitro fertilisation

Polycystic Ovary Syndrome;
Polycystic Ovary Syndrome

Intervention(s)

120 women with PCOS were randomly divided to 3 groups: group I (40 women) received clomiphene citrate (CC) only100 mg orally in two divided doses from day 3 until day 7 of the menstrual cycle, group II (40 women) received CC 100 mg orally in two divided doses from day 3 until day 7 of the menstrual cycle plus N-acetyl cysteine (NAC) 1200 mg orally in two divided doses in the form of powder inserted in small pockets to be diluted into one standard glass of water from day 3 until day 7 of the menstrual cycle and group III (40 women) received CC 100 mg orally in two divided doses from day 3 until day 7 of the menstrual cycle plus metformin 500 mg orally three times daily continuously for 4 weeks
Monitoring through A transvaginal ultrasonography (TVS) using Toshiba femio 5 (Toshiba Medical Solutions Inc., Ultrasound Division, Japan) equipped with a 6.5 MHz transvaginal transducer on alternate days starting from cycle day 9 till ovulation to determine the follicular number, size, endometrial thickness and pattern and evidence of follicular rupture.

Primary Outcome(s)

pregnancy rate (clinical pregnancy defined as the presence of gestational sac containing fetal heartbeats on ultrasound scan)[2 weeks after missed period]

Secondary Outcome(s)

endometrial thickness measured by transvaginal ultrasound[at Baseline and every 2 days till ovulation]

size of follicles measured by transvaginal ultrasound[at Baseline and every 2 days till ovulation]

Secondary ID(s)

nil

Source(s) of Monetary Support

Ahmed Maged

Secondary Sponsor(s)

Aly Abdelhafez

Ethics review

Status: Approved
Approval date:
Contact:

Cairo university