Added Value of N Acetyle Cysteine to Clomiphene Citrate in PCO
Sponsor
Aljazeera Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT04170439
Collaborator
Cairo University (Other)
108
2
3
5.8
54
9.3
Study Details
Study Description
Brief Summary
PCO is one of the factors associated with delayed conception
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
In an attempt to induce ovulation Clomiphene citrate can be given in conjunction with N acetyle cysteine
Study Design
Study Type:
Interventional
Actual Enrollment
:
108 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Women who will receive clomiphe citrate plus N acetyle cysteine rally in arm number 1 And women who will receive clomiphene citrate and chromoum in arm number 22Women who will receive clomiphe citrate plus N acetyle cysteine rally in arm number 1 And women who will receive clomiphene citrate and chromoum in arm number 22
Masking:
Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
The Added Value of n Acetyle Cysteine and Chromium to Clomiphene Citrate in PCO
Actual Study Start Date
:
Nov 20, 2019
Actual Primary Completion Date
:
May 2, 2020
Actual Study Completion Date
:
May 15, 2020
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Other: clomiphene plus metformin plus N acetyle cysteine Women who will receive clomiphene citrate plus metformin plus n acetyle cysteine |
Drug: Clomiphene plus metformin plus N acetyle cysteine in arm number 1
oral adminstration of clomiphene citrate plus metformin plus N acetyl cysteine or chromium
|
| Other: clomiphene plus metformin plus chromium Women who will receive clomiphene plus metformin plus chromium |
Drug: Clomiphene citrate plus metformin with chromium
oral adminstration of clomiphene citrate plus metformin and chromium
|
| Other: clomiphen citrate plus metformin Women who will receive clomiphene plus metformin |
Drug: clomiphene citrate plus metformin
oral adminstration of clomiphene citrate plus metformin
|
Outcome Measures
Primary Outcome Measures
- The number of women who will have mature follicles wih their size and number of mqture follicles The number of women who will have mature follicles [within 2 weeks]
Assessment of women in both groups for size and number of follicles
Eligibility Criteria
Criteria
Ages Eligible for Study:
20 Years
to 40 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
Inclusion Criteria:
- women with PCO
Exclusion Criteria:
- women who donot have PCO
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Algazeerah and Kasralainy hospital | Giza | Egypt | ||
| 2 | Algazeerah | Giza | Egypt |
Sponsors and Collaborators
- Aljazeera Hospital
- Cairo University
Investigators
- Study Director: Mahmoud Alalfy, PhD, Algezeera
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Mahmoud Alalfy,
Lecturer in national research crntre and Algezzera hospital ,egypt,
Aljazeera Hospital
ClinicalTrials.gov Identifier:
NCT04170439
Other Study ID Numbers:
- chromium in infertility
First Posted:
Nov 20, 2019
Last Update Posted:
Apr 28, 2021
Last Verified:
Apr 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms: