Effect of Vitamin D Oral Supplementation in Poly Csytic Ovarian Women Resistant to Clomiphene Citrate
Primary Purpose
Vitamin D Deficiency, Clomiphene Allergy, Polycystic Ovary Syndrome
Status
Unknown status
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Vitamin D
Clomid
Sponsored by
About this trial
This is an interventional treatment trial for Vitamin D Deficiency focused on measuring Poly cystic ovary syndrome, Vitamin D
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
pcos resistant to cc plus vit d
Arm Description
100 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
Outcomes
Primary Outcome Measures
number of the ovulated follicles
Number of ovulated follicles by trans vaginal ultra sound signs of ovulation
Secondary Outcome Measures
pregancy rate
Pregnancy test positive by quantititave see beta HCG level
Evaluation of the endometrial thickness
Measure the endometrium thickness by transvaginal ultrasound
Full Information
NCT ID
NCT04916925
First Posted
July 21, 2019
Last Updated
June 1, 2021
Sponsor
rana alaaeldin aly ibrahim nasr
Collaborators
Ain Shams University
1. Study Identification
Unique Protocol Identification Number
NCT04916925
Brief Title
Effect of Vitamin D Oral Supplementation in Poly Csytic Ovarian Women Resistant to Clomiphene Citrate
Official Title
Effect of Vitamin D Oral Supplementation in Poly Cystic Ovarian Women Resistant to Clomiphene Citrate
Study Type
Interventional
2. Study Status
Record Verification Date
June 2021
Overall Recruitment Status
Unknown status
Study Start Date
August 21, 2021 (Anticipated)
Primary Completion Date
September 1, 2021 (Anticipated)
Study Completion Date
December 1, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
rana alaaeldin aly ibrahim nasr
Collaborators
Ain Shams University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
effect of vitamin D oral supplementation in poly csytic ovarian women resistant to clomiphene citrate
Detailed Description
Polycystic ovarian syndrome is the most common endocrine disorder . It is associated with chronic anovulation and infertility. The diagnosis is made by clinical and ancillary investigations revealing the presence of irregular menstrual cycles, an ovulation , Hyperandrgenemia , and the presence of polycystic ovaries (ovarian morphology as the presence of 12 or more follicles measuring 2-9 mm in diameter and an increased ovarian volume >10 cm 3) ovulation can be induced with clomiphene citrate (CC), However, ~20%-25% of anovulatory women with PCOS do not respond to CC and are considered to be "clomiphene-resistant( clomiphene citrate resistance means failure to ovulate with 3 months use of clomid at 150 mg/day for 5 days ) Vitamin D may serve as a key in preventing and attenuating the insulin resistance. Vitamin D plays a physiologic role in reproduction including ovarian follicular development and luteinisation, follicle-stimulating hormone sensitivity and progesterone production in human granulosa cells. It also affects glucose homeostasis .
In this trial 100 women with PCO disease that diagnosed by ROTTERDAM CRITERIA (must have any TWO of This findings: Hyperandrogenism, Oligomenorrhea, Polycystic ovaries). Who are taking clomiphene citrate for induction of ovulation and resistant to it, which means failure to ovulate with 3 months of usage of clomid at 150 mg/day for 5 days. They will recieve vitamin D (ossofortin®, Eva Pharma) orally 10000 IU twice weekly for other three months period with clomiphene citrate orally 150 mg/day for 5 days. Number and size of the growing follicles will be monitored before and after taking vitamin D by trans-vaginal ultrasound at day11-14 of the cycle till day 21 to detect effect of vitamin D in ovulation rate.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vitamin D Deficiency, Clomiphene Allergy, Polycystic Ovary Syndrome
Keywords
Poly cystic ovary syndrome, Vitamin D
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Model Description
a single arm clinical trail
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
pcos resistant to cc plus vit d
Arm Type
Experimental
Arm Description
100 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
Intervention Type
Drug
Intervention Name(s)
Vitamin D
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Clomid
Intervention Description
CLOMID is adrug used for ovulation induction
Primary Outcome Measure Information:
Title
number of the ovulated follicles
Description
Number of ovulated follicles by trans vaginal ultra sound signs of ovulation
Time Frame
36 hours of taking HCG injection
Secondary Outcome Measure Information:
Title
pregancy rate
Description
Pregnancy test positive by quantititave see beta HCG level
Time Frame
2 days after delayed menses
Title
Evaluation of the endometrial thickness
Description
Measure the endometrium thickness by transvaginal ultrasound
Time Frame
36 hour of taking HCG
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
in child bearing age
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
rana nasr
Phone
01274901443
Email
roona_015@yahoo.com
First Name & Middle Initial & Last Name or Official Title & Degree
alhassan khedr
Phone
01006193797
Email
alhassankhedr@med.asu.edu.eg
12. IPD Sharing Statement
Learn more about this trial
Effect of Vitamin D Oral Supplementation in Poly Csytic Ovarian Women Resistant to Clomiphene Citrate
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