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

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12614000697684

Enrollment

120

Registered

2014-07-02

Start date

2012-09-01

Completion date

2014-03-31

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

to assess the adjuvant effect of metformine and N-acetylcysteine to clomiphene citrate in induction of ovulation in patients with PCOS

Interventions

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.

Study design

Allocation

Randomised controlled trial

Primary purpose

Treatment

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

19 Years to 35 Years

Healthy volunteers

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.

Outcome results