Clomiphene Plus N-acetyl Cysteine for Induction of Ovulation in Newly Diagnosed Pcos.

NCT01896492 | Completed Phase 4 DMC

• 1 other identifier: ccpnacinovi
• Study Type: interventional
• Target: 200
• Locations: 0 countries
• Sites: N/A

Brief Summary

Polycystic ovary syndrome (PCOS) is one of the most common endocrine disorders, affecting approximately 6-10% of women of reproductive age. Anovulation, infertility and hyperandrogenism often co-exist with hyperinsulinaemia and insulin resistance . Clomiphene citrate remains the standard drug for induction or augmentation of ovulation. However, it is not equally effective in all situations, and therefore it may require additional expensive drugs such as N-acetyl cysteine, as an antioxidant, has been suggested as an adjuvant in clomiphene-resistant cases .NAC may also improve the circulating level of insulin and insulin sensitivity in hyperinsulinaemic women with PCOS, and may be useful for the treatment of insulin resistance by ameliorating the homocysteine and lipid profile in PCOS .

Conditions

PCOS

Keywords

PCOS,; NAC,; OVULATION INDUCTION,; CLOMOPHEN CITRATE

Outcome Measures

Primary Outcomes (1)

• Ovulation rate

  Clomiphene citrate, 100 mg, was given from day 3 until day 7. In addition to the CC, each patient was selected randomly to receive either NAC (Sedico, Cairo, ARE), in a dose of 1.2 g/d orally, or a placebo (sugar) of the same volume twice daily from day 3 until day 7. Monitoring of the cycle will involve transvaginal determination of the mean follicular diameter and measurement of serum E2 levels. Monitoring intervals will be determined by patient response.

  2 years

Secondary Outcomes (1)

• include PR, number of follicles of ≥ 18 mm, the serum E2 concentration, serum P, and endometrial thickness

  2 years

Study Arms (3)

N-acetyl cystien and clomiphen citrate

ACTIVE COMPARATOR

N-acetyl cystien and clomiphen citrate,in induction of ovulation in newly diagnosed PCOS,1-2gm schats of NAC PLUS 100 mg of cc in the therd day of the cycle till day 8,with monitoring of follicular growth usin ultrasonography.HCG is giving to trigger of ovulation fo follicular size 18mm or more.

Drug: NAC

Clomiphen citrate and placebo

PLACEBO COMPARATOR

CC plus placebo compared to cc and NAC in induction of ovulation in PCOS new cases.

Drug: NAC

N-acetyl cystien

NO INTERVENTION

In addition to the CC, each patient was selected randomly to receive either NAC (Sedico, Cairo, ARE), in a dose of 1.2 g/d orally, or a placebo (sugar) of the same volume twice daily from day 3 until day 7

Interventions

NAC DRUG

NAC 2gm plus cc 100mg from 3rd day of the cycle till day 8 with u/s follow up of the follicular growth.

Also known as: N-acetyl cystien

Clomiphen citrate and placebo; N-acetyl cystien and clomiphen citrate

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• PCOS diagnosed by Rotterdam's criteria

You may not qualify if:

• previous induction of ovulation male factoe infertility tubal factor infertility uterine factor infertility

Sponsors & Collaborators

• Woman's Health University Hospital, Egypt: lead

Study Officials

• Alaa M Ismail, M D

  Woman's Health University Hospital, Egypt

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M D

Study Record Dates

• First Submitted: June 22, 2013
• First Posted: July 11, 2013
• Study Start: January 1, 2011
• Primary Completion: June 1, 2013
• Study Completion: June 1, 2013
• Last Updated: August 12, 2020

Record last verified: 2020-08