Phytoestrogen, NO Donors, N-acetyl Cysteine Add Therapy to Clomiphene Citrate to Improve Pregnancy Rate in PCO Patients

NCT ID: NCT02493933

Last Updated: 2015-07-14

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1
• Total Enrollment: 240 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-07-31
• Study Completion Date: 2015-12-31

Brief Summary

To evaluate the effect of oral Phytoestrogen or Isosorbid mononitrate or N-acetyl cysteine as an adjuvant to clomiphene citrate on induction of ovulation and pregnancy outcomes in patients with PCOS. In this three-arm open RCT, 240 PCOS infertile women were randomly divided to 3 groups for induction of ovulation. Group A, [PE group, n= 80] patients received CC 100mg/d plus oral Phytoestrogen120 mg/ day and patients in Group B, [ISMN group, n=80] received CC 100 mg/d plus 20 mg Isosorbid mononitrate and Group C, [NAC group, n=80] patients received CC 100 mg/d plus NAC 1200 mg/day.

Conditions

Infertility

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Phytoestrogen

Patients received oral PE 120 mg/ day in the form of dry coated tablets (Klimadynon, Bionorica, Germany) 2 tablets three times daily from day 1 to day 12 as adjuvant to CC in the follicular phase of the cycle.

Group Type: ACTIVE_COMPARATOR

Phytoestrogens, Isosorbid mononitrate, N-acetyl cysteine

Intervention Type: DRUG

Isosorbid mononitrate

Patients received in addition to CC 20 mg Isosorbid mononitrate (ISMN) tablet (EFFOX, Minapharm Co., Egypt under licence of Shwartz pharma,Germany) applied vaginally from day 1 to day 12 of the cycle.

Group Type: ACTIVE_COMPARATOR

Phytoestrogens, Isosorbid mononitrate, N-acetyl cysteine

Intervention Type: DRUG

N-Acetyl cysteine

Patients received supplementation to CC with NAC 1200 mg/day orally (N-acetyl cysteine, Sedico, Cairo, ARE) sachets 200 mg each, as two sachets thrice daily from day 1 to day 12 of the cycle.

Group Type: ACTIVE_COMPARATOR

Phytoestrogens, Isosorbid mononitrate, N-acetyl cysteine

Intervention Type: DRUG

Interventions

Phytoestrogens, Isosorbid mononitrate, N-acetyl cysteine

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. All patients have PCOS.

2. All patients received CC 100 mg/day for 5 days starting from day 5 with successful ovulation as documented by folliculometry and midluteal serum progesterone with no pregnancy achieved.

3. All patients have patent fallopian tubes by Hysterosalpingography.

4. Their husbands have normal semen analysis according to the modified criteria of WHO.

5. All patients have normal serum prolactin and thyroid profile.

6. Any patient having vaginitis was treated before starting induction.

Exclusion Criteria

1. Other causes of infertility than anovulation.

2. Diabetes or other endocrinological disorders.

3. Age > 40 years.

4. Smoking.

5. Alcohol use.

6. Presence of ovarian cyst >2cm on the second day of the cycle.

7. Patients who have received gonadotrophins in the preceeding 6 months.

8. Patients who have done unilateral or bilateral ovarian drilling.

9. Allergy to PE, NO donors or NAC

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Kasr El Aini Hospital

OTHER

Sponsor Role: lead

Responsible Party

Nawara Mohamed Hashish

Assistant professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

43-2015

Identifier Type: -

Identifier Source: org_study_id