Back to resultsPhytoestrogen, NO Donors, N-acetyl Cysteine Add Therapy to Clomiphene Citrate to Improve Pregnancy Rate in PCO Patients
Primary Purpose
Infertility
Status
Unknown status
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Phytoestrogens, Isosorbid mononitrate, N-acetyl cysteine
Sponsored by
About this trial
This is an interventional treatment trial for Infertility
Eligibility Criteria
Inclusion Criteria:
- All patients have PCOS.
- 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.
- All patients have patent fallopian tubes by Hysterosalpingography.
- Their husbands have normal semen analysis according to the modified criteria of WHO.
- All patients have normal serum prolactin and thyroid profile.
- Any patient having vaginitis was treated before starting induction.
Exclusion Criteria:
- Other causes of infertility than anovulation.
- Diabetes or other endocrinological disorders.
- Age > 40 years.
- Smoking.
- Alcohol use.
- Presence of ovarian cyst >2cm on the second day of the cycle.
- Patients who have received gonadotrophins in the preceeding 6 months.
- Patients who have done unilateral or bilateral ovarian drilling.
- Allergy to PE, NO donors or NAC
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Active Comparator
Arm Label
Phytoestrogen
Isosorbid mononitrate
N-Acetyl cysteine
Arm Description
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.
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.
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.
Outcomes
Primary Outcome Measures
clinical pregnancy rate
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02493933
Brief Title
Phytoestrogen, NO Donors, N-acetyl Cysteine Add Therapy to Clomiphene Citrate to Improve Pregnancy Rate in PCO Patients
Official Title
Phytoestrogen, NO Donors, N-acetyl Cysteine Add Therapy to Clomiphene
Study Type
Interventional
2. Study Status
Record Verification Date
July 2015
Overall Recruitment Status
Unknown status
Study Start Date
July 2015 (undefined)
Primary Completion Date
December 2015 (Anticipated)
Study Completion Date
December 2015 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kasr El Aini Hospital
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
240 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Phytoestrogen
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Isosorbid mononitrate
Arm Type
Active Comparator
Arm Description
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.
Arm Title
N-Acetyl cysteine
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Phytoestrogens, Isosorbid mononitrate, N-acetyl cysteine
Primary Outcome Measure Information:
Title
clinical pregnancy rate
Time Frame
6 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
All patients have PCOS.
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.
All patients have patent fallopian tubes by Hysterosalpingography.
Their husbands have normal semen analysis according to the modified criteria of WHO.
All patients have normal serum prolactin and thyroid profile.
Any patient having vaginitis was treated before starting induction.
Exclusion Criteria:
Other causes of infertility than anovulation.
Diabetes or other endocrinological disorders.
Age > 40 years.
Smoking.
Alcohol use.
Presence of ovarian cyst >2cm on the second day of the cycle.
Patients who have received gonadotrophins in the preceeding 6 months.
Patients who have done unilateral or bilateral ovarian drilling.
Allergy to PE, NO donors or NAC
12. IPD Sharing Statement
Learn more about this trial
Phytoestrogen, NO Donors, N-acetyl Cysteine Add Therapy to Clomiphene Citrate to Improve Pregnancy Rate in PCO Patients
We'll reach out to this number within 24 hrs