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The Effect Of Vitamin D Replacement Therapy On Serum Leptin And Follicular Growth Pattern In Women With Resistant Polycystic Ovary

Sponsor
Cairo University (Other)
Overall Status
Unknown status
CT.gov ID
NCT03806036
Collaborator
(none)
100
Enrollment
1
Location
2
Arms
13
Anticipated Duration (Months)
7.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The study included 100 female diagnosed with polycystic ovary syndrome. They were classified into 2 groups: Study group included 50 women will receive 300.000 I.U single dose of Vitamin D intramuscular injection (Memphis company) , and in the next menstrual cycle induction done by clomiphen citrate 100mg daily for 5 days starting from third day of menstruation and HMG single dose on 8th day . Control group included 50 women will receive only clomiphen citrate 100mg daily for 5 days starting from third day of menstruation and HMG single dose on 8th day. Serum 25 hydroxy Vitamin D3, Serum Leptin and FSH will be done to all women before and after intervention.

Condition or Disease Intervention/Treatment Phase
  • Drug: Vitamin D
  • Drug: Clomiphene Citrate
 Phase 4

Detailed Description

The study included 100 female diagnosed with polycystic ovary syndrome diagnosed by by presence of 2 out of 3 criteria (according to ESHRE/ASRM in Rotterdam in 2003): oligoovulation and/or an ovulation , excess androgen activity (clinical or biochemical) and polycystic ovaries (by pelvic ultrasound "vaginal route").They were classified into 2 groups: Study group included 50 women will receive 300.000 I.U single dose of Vitamin D intramuscular injection (Memphis company) , and in the next menstrual cycle induction done by clomiphen citrate 100mg daily for 5 days starting from third day of menstruation and HMG single dose on 8th day . Control group included 50 women will receive only clomiphen citrate 100mg daily for 5 days starting from third day of menstruation and HMG single dose on 8th day. Serum 25 hydroxy Vitamin D3, Serum Leptin and FSH will be done to all women before and after intervention.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
100 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
The Effect Of Vitamin D Replacement Therapy On Serum Leptin And Follicular Growth Pattern In Women With Resistant Polycystic Ovarian Syndrome
Actual Study Start Date :
Jan 2, 2018
Anticipated Primary Completion Date :
Feb 1, 2019
Anticipated Study Completion Date :
Feb 1, 2019

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Vitamin D group

50 women will receive 300.000 I.U single dose of VIT D IM injection (Memphis company) , and in the next menstrual cycle induction done by clomiphen citrate 100mg daily for 5 days starting from third day of menstruation and HMG single dose on 8th day

Drug: Vitamin D
300.000 I.U single dose of VIT D IM injection

Drug: Clomiphene Citrate
100mg daily for 5 days starting from third day of menstruation
Other Names:
  • Clomid

    		•
    Placebo Comparator: Control group

    50 women will receive clomiphen citrate 100mg daily for 5 days starting from third day of menstruation and HMG single dose on 8th day

    Drug: Clomiphene Citrate
    100mg daily for 5 days starting from third day of menstruation
    Other Names:
  • Clomid

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Ovulation [14 days after menses]

      appearance of dominant follicle 18 - 22 mm in diameter

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years to 40 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    1- BMI: more than 25.0 kg/m2

    2- PCO was diagnosed by presence of 2 out of 3 criteria (according to ESHRE/ASRM in Rotterdam in 2003)

    1. oligoovulation and/or an ovulation

    2. excess androgen activity (clinical or biochemical)

    3. polycystic ovaries (by pelvic ultrasound "vaginal route")

    3- Anovulatory patient resistant to induction with clomiphene citrate alone

    Exclusion Criteria:

    -1) BMI: more than 35.0 kg/m2

    1. Infertile women due to any factor other than PCO

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Kasr Alainy medical school Cairo Egypt 12151

    Sponsors and Collaborators

    • Cairo University

    Investigators

    • Principal Investigator: Ahmed Maged, Professor

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Ahmed Maged, Principal investigator, Cairo University
    ClinicalTrials.gov Identifier:
    NCT03806036
    Other Study ID Numbers:
    • 47
    First Posted:
    Jan 16, 2019
    Last Update Posted:
    Jan 16, 2019
    Last Verified:
    Jan 1, 2019
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Polycystic Ovary Syndrome
    Syndrome
    Vitamin D
    Clomiphene
    Enclomiphene
    Zuclomiphene

    Study Results

    No Results Posted as of Jan 16, 2019