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

Phase 1

• Conditions: Infertility
• Interventions: Drug: Phytoestrogens, Isosorbid mononitrate, N-acetyl cysteine

• Registration Number: NCT02493933
• Lead Sponsor: Kasr El Aini Hospital

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2015-07
• Study Start: 2015-07
• Study First Submitted: 2015-07-07
• Study First Submitted QC: 2015-07-07
• Study First Posted: 2015-07-10
• Last Update Submitted: 2015-07-10
• Last Update Posted: 2015-07-14
• Primary Completion: 2015-12
• Study Completion: 2015-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 240

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Isosorbid mononitrate	Phytoestrogens, Isosorbid mononitrate, N-acetyl cysteine	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.
N-Acetyl cysteine	Phytoestrogens, Isosorbid mononitrate, 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.
Phytoestrogen	Phytoestrogens, Isosorbid mononitrate, N-acetyl cysteine	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.

Primary Outcome Measures

Name	Time	Method
clinical pregnancy rate	6 months