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

Primary Purpose

Polycystic Ovary Syndrome

Status

Unknown status

Phase

Phase 4

Locations

Egypt

Study Type

Interventional

Intervention

Vitamin D

Clomiphene Citrate

About this trial

This is an interventional treatment trial for Polycystic Ovary Syndrome

Eligibility Criteria

20 Years - 40 Years (Adult)FemaleDoes not accept healthy volunteers

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)

oligoovulation and/or an ovulation
excess androgen activity (clinical or biochemical)
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

2) Infertile women due to any factor other than PCO

Sites / Locations

Kasr Alainy medical schoolRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Vitamin D group

Control group

Arm Description

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

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

Outcomes

Primary Outcome Measures

Ovulation

appearance of dominant follicle 18 - 22 mm in diameter

Secondary Outcome Measures

Full Information

NCT ID

NCT03806036

First Posted

January 13, 2019

Last Updated

January 13, 2019

Sponsor

Cairo University

1. Study Identification

Unique Protocol Identification Number

NCT03806036

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2019

Overall Recruitment Status

Unknown status

Study Start Date

January 2, 2018 (Actual)

Primary Completion Date

February 2019 (Anticipated)

Study Completion Date

February 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Cairo University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Polycystic Ovary Syndrome

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Vitamin D group

Arm Type

Active Comparator

Arm Description

Arm Title

Control group

Arm Type

Placebo Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Vitamin D

Intervention Description

300.000 I.U single dose of VIT D IM injection

Intervention Type

Drug

Intervention Name(s)

Clomiphene Citrate

Other Intervention Name(s)

Clomid

Intervention Description

100mg daily for 5 days starting from third day of menstruation

Primary Outcome Measure Information:

Title

Ovulation

Description

appearance of dominant follicle 18 - 22 mm in diameter

Time Frame

14 days after menses

10. Eligibility

Sex

Female

Gender Based

Yes

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

40 Years

Accepts Healthy Volunteers

Eligibility Criteria

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) oligoovulation and/or an ovulation excess androgen activity (clinical or biochemical) 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 2) Infertile women due to any factor other than PCO

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Ahmed Maged, MD

Phone

+201005227404

prof.ahmedmaged@gmail.com

First Name & Middle Initial & Last Name or Official Title & Degree

Wesam Deeb, MD

wessamdeeb74@gmail.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ahmed Maged

Organizational Affiliation

Professor

Official's Role

Principal Investigator

Facility Information:

Facility Name

Kasr Alainy medical school

City

Cairo

ZIP/Postal Code

12151

Country

Egypt

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Ahmed Maged, MD

Phone

01005227404

prof.ahmedmaged@gmail.com

12. IPD Sharing Statement

Learn more about this trial

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

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