Phytoestrogen, NO Donors, N-acetyl Cysteine Add Therapy to Clomiphene Citrate to Improve Pregnancy Rate in PCO Patients
1 other identifier
interventional
240
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Jul 2015
Shorter than P25 for phase_1
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2015
CompletedFirst Submitted
Initial submission to the registry
July 7, 2015
CompletedFirst Posted
Study publicly available on registry
July 10, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2015
CompletedJuly 14, 2015
July 1, 2015
5 months
July 7, 2015
July 10, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
clinical pregnancy rate
6 months
Study Arms (3)
Phytoestrogen
ACTIVE COMPARATORPatients 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.
Isosorbid mononitrate
ACTIVE COMPARATORPatients 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
ACTIVE COMPARATORPatients 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.
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant professor
Study Record Dates
First Submitted
July 7, 2015
First Posted
July 10, 2015
Study Start
July 1, 2015
Primary Completion
December 1, 2015
Study Completion
December 1, 2015
Last Updated
July 14, 2015
Record last verified: 2015-07