Effect of Vitamin D Oral Supplementation in Poly Csytic Ovarian Women Resistant to Clomiphene Citrate
1 other identifier
interventional
100
0 countries
N/A
Brief Summary
effect of vitamin D oral supplementation in poly csytic ovarian women resistant to clomiphene citrate
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Aug 2021
Shorter than P25 for phase_1
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 21, 2019
CompletedFirst Posted
Study publicly available on registry
June 8, 2021
CompletedStudy Start
First participant enrolled
August 21, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2021
CompletedJune 8, 2021
June 1, 2021
11 days
July 21, 2019
June 1, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
number of the ovulated follicles
Number of ovulated follicles by trans vaginal ultra sound signs of ovulation
36 hours of taking HCG injection
Secondary Outcomes (2)
pregancy rate
2 days after delayed menses
Evaluation of the endometrial thickness
36 hour of taking HCG
Study Arms (1)
pcos resistant to cc plus vit d
EXPERIMENTAL100 patients who are PCOS and resist CC will receive Vitamin D 10000 IU orally plus 150mg clomid orally for 3 months number and size of growing follicles will be monitored
Interventions
Adding vitamin D to PCOS patients who are resistant to clomiphene regime for induction will or not improve the Clinical pregnancy rate and will or not increase chances of ovulation and pregnancy.
Eligibility Criteria
You may qualify if:
- Age: 18-40 years 2- Polycystic ovarian syndrome diagnosis made according to ESHRE/ASRM criteria.
- Polycystic ovaries (either 12 or more follicles or increased ovarian volume \[\> 10 cm3
- Oligo-ovulation or anovulation
- Clinical and/or biochemical signs of hyperandrogenism (Azziz, 2006). 3- PCOS infertile women resistant to CC for 3 cycles. clomiphene citrate resistance means failure to ovulate with 3 months use of clomid at 150 mg/day for 5 days
You may not qualify if:
- Causes of infertility other than PCOS.
- Male factor.(normal semen analysis)
- Other factors e.g. endometriosis
- Tubal factor. (normal hysterosalpingography)
- Premature ovarian failure: Day 3 FSH \> 14 mlu/ml or antimullerian hormone \<1 ng/ml.
- Normal ultrasound except for criteria of PCO
- Causes of anovulation other than PCOS.
- Patients with hyperprolactinemia
- Patients with thyroid dysfunction.
- Current or in last six months use of vit D treatment.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- rana alaaeldin aly ibrahim nasrlead
- Ain Shams Universitycollaborator
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Clinical gynecology professor
Study Record Dates
First Submitted
July 21, 2019
First Posted
June 8, 2021
Study Start
August 21, 2021
Primary Completion
September 1, 2021
Study Completion
December 1, 2021
Last Updated
June 8, 2021
Record last verified: 2021-06