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

Phytoestrogen, NO Donors, N-acetyl Cysteine Add Therapy to Clomiphene

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.

Study Overview

• Status: Unknown
• Conditions: Infertility
• Intervention / Treatment: Drug: Phytoestrogens, Isosorbid mononitrate, N-acetyl cysteine

• Study Type: Interventional
• Enrollment (Anticipated): 240
• Phase: Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 40 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	Drug: Phytoestrogens, Isosorbid mononitrate, N-acetyl cysteine
Active Comparator: 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.	Drug: Phytoestrogens, Isosorbid mononitrate, N-acetyl cysteine
Active Comparator: 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.	Drug: Phytoestrogens, Isosorbid mononitrate, N-acetyl cysteine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
clinical pregnancy rate	6 months

Collaborators and Investigators

• Sponsor: Kasr El Aini Hospital

Study record dates

Study Major Dates

• Study Start: July 1, 2015
• Primary Completion (Anticipated): December 1, 2015
• Study Completion (Anticipated): December 1, 2015

Study Registration Dates

• First Submitted: July 7, 2015
• First Submitted That Met QC Criteria: July 7, 2015
• First Posted (Estimate): July 10, 2015

Study Record Updates

• Last Update Posted (Estimate): July 14, 2015
• Last Update Submitted That Met QC Criteria: July 10, 2015
• Last Verified: July 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infertility; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antiviral Agents; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Protective Agents; Estrogens, Non-Steroidal; Estrogens; Respiratory System Agents; Antioxidants; Antidotes; Free Radical Scavengers; Expectorants; Acetylcysteine; N-monoacetylcystine; Phytoestrogens
• Other Study ID Numbers: 43-2015