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Correction of Vitamin D Deficiency and Its Effect on Ovulation Induction in Women With PCOS (VIDEO): A Feasibility RCT (PCOSD)

Primary Purpose

PCOS

Status

Completed

Phase

Phase 2

Locations

Egypt

Study Type

Interventional

Intervention

Vitamin D

Ovulatory Agent

About this trial

This is an interventional treatment trial for PCOS focused on measuring PCOS, vitamin D

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

diagnosed PCOS cases according to the National Institute of Health criteria (NIH consensus criteria) and Rotterdam criteria

Exclusion Criteria:

1- PCOS patients not in child bearing age; less than 18 years or more than 45 years.
2- Patients with congenital adrenal hyperplasia, androgen-secreting tumors, Cushing's syndrome, hyperprolactinemia and virilizing ovarian or adrenal tumors.
3- PCOS patients with any other medical illness. 4- PCOS patients already on vitamin D supplements.

Sites / Locations

Faculty of Medicine, Ain Shams University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Vitamin D

control

Arm Description

1st subgroup will be tested and treated with vitamin D together with Clomiphene Citrate for induction of ovulation

2nd subgroup will be treated with Clomophene Citrate only

Outcomes

Primary Outcome Measures

cumulative clomiphene citrate-induced ovulation rates

Ultrasound Folliculometry was performed every other day starting on the 10th day of the induction cycle. Until, at least, one follicle reached 18mm in diameter

Secondary Outcome Measures

Cumlative clinical pregnancy rate

detection of fetal heart activity detected by transvaginal ultrasound

median ovulating dose of clomiphene citrate

Dose required

Full Information

NCT ID

NCT02656121

First Posted

January 12, 2016

Last Updated

November 15, 2018

Sponsor

Ain Shams University

1. Study Identification

Unique Protocol Identification Number

NCT02656121

Brief Title

Correction of Vitamin D Deficiency and Its Effect on Ovulation Induction in Women With PCOS (VIDEO): A Feasibility RCT

Acronym

PCOSD

Official Title

Correction of Vitamin D Deficiency and Its Effect on Ovulation Induction in Women With PCOS (VIDEO): A Feasibility RCT

Study Type

Interventional

2. Study Status

Record Verification Date

November 2018

Overall Recruitment Status

Completed

Study Start Date

February 2016 (Actual)

Primary Completion Date

November 2018 (Actual)

Study Completion Date

November 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Ain Shams University

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

Recently, a special emphasis has recently been directed to the potential role of vitamin D and some regulatory peptides (e.g. adipokines and follistatin) and their associated metabolic roles and genetic factors in the development of PCOS and its related co-morbidities. The aim of this study was to assess the feasibility of conducting a pragmatic RCT assessing the effectiveness of adopting a protocol of screening for and correcting Vitamin D deficiency in women with PCOS seeking fertility treatment in a low/middle income care (LMIC) setting

Detailed Description

Research question: In PCOS patients, is there any effect of vitamin D testing and correction on ovulation induction in women with PCOS? Research hypothesis: There is effect of testing and correcting vitamin D status as regard ovulation in patients with PCOS

6. Conditions and Keywords

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

PCOS

Keywords

PCOS, vitamin D

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

300 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Vitamin D

Arm Type

Experimental

Arm Description

1st subgroup will be tested and treated with vitamin D together with Clomiphene Citrate for induction of ovulation

Arm Title

control

Arm Type

Active Comparator

Arm Description

2nd subgroup will be treated with Clomophene Citrate only

Intervention Type

Drug

Intervention Name(s)

Vitamin D

Other Intervention Name(s)

Vidrop®, Medical Union Pharmaceuticals, Egypt

Intervention Description

6000 IU of vitamin D3

Intervention Type

Drug

Intervention Name(s)

Ovulatory Agent

Other Intervention Name(s)

Clomiphene Citrate for induction of ovulation

Intervention Description

only Clomophine Citrate

Primary Outcome Measure Information:

Title

cumulative clomiphene citrate-induced ovulation rates

Description

Ultrasound Folliculometry was performed every other day starting on the 10th day of the induction cycle. Until, at least, one follicle reached 18mm in diameter

Time Frame

6 months

Secondary Outcome Measure Information:

Title

Cumlative clinical pregnancy rate

Description

detection of fetal heart activity detected by transvaginal ultrasound

Time Frame

6 months

Title

median ovulating dose of clomiphene citrate

Description

Dose required

Time Frame

6 months

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

45 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: diagnosed PCOS cases according to the National Institute of Health criteria (NIH consensus criteria) and Rotterdam criteria Exclusion Criteria: 1- PCOS patients not in child bearing age; less than 18 years or more than 45 years. 2- Patients with congenital adrenal hyperplasia, androgen-secreting tumors, Cushing's syndrome, hyperprolactinemia and virilizing ovarian or adrenal tumors. 3- PCOS patients with any other medical illness. 4- PCOS patients already on vitamin D supplements.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ahmed M kotb, MD

Organizational Affiliation

Ain Shams University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Faculty of Medicine, Ain Shams University

City

Cairo

State/Province

Al Qahirah

Country

Egypt

12. IPD Sharing Statement

Plan to Share IPD

Yes

Learn more about this trial

Correction of Vitamin D Deficiency and Its Effect on Ovulation Induction in Women With PCOS (VIDEO): A Feasibility RCT

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