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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
rana alaaeldin aly ibrahim nasr
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Vitamin D Deficiency focused on measuring Poly cystic ovary syndrome, Vitamin D

Eligibility Criteria

18 Years - 40 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Age: 18-40 years 2- Polycystic ovarian syndrome diagnosis made according to ESHRE/ASRM criteria.

    1. Polycystic ovaries (either 12 or more follicles or increased ovarian volume [> 10 cm3
    2. Oligo-ovulation or anovulation
    3. 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.

    1. Male factor.(normal semen analysis)
    2. Other factors e.g. endometriosis
    3. Tubal factor. (normal hysterosalpingography)
    4. Premature ovarian failure: Day 3 FSH > 14 mlu/ml or antimullerian hormone <1 ng/ml.
    5. 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

    First Posted
    July 21, 2019
    Last Updated
    June 1, 2021
    Sponsor
    rana alaaeldin aly ibrahim nasr
    Collaborators
    Ain Shams University
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    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

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    Effect of Vitamin D Oral Supplementation in Poly Csytic Ovarian Women Resistant to Clomiphene Citrate

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