Vitamin D for Polycystic Ovary Syndrome Clomiphene Resistant Women

NCT04010942 | Completed Phase 4 DMC

• 1 other identifier: VitDPcos
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

This study is determining the therapeutic effect of Vitamin D supplements to Pcos clomiphene resistant polycystic ovarian syndrome Women. Half of patients will receive Vitamin D with metformin while other half metformin only. Then both groups start clomiphene for 3 month

Conditions

PCOS; Vitamin D Deficiency

Outcome Measures

Primary Outcomes (3)

• Follicle growth and maturation

  Transvaginal ultrasound will be done every 48 hours at the start from day 10 of the cycle to assess if the follicle reaches 17-19 mm

  11days

• Change in Follicle growth and maturation at 3rd month

  Transvaginal ultrasound will be done every 48 hours at the start from day 10 of the cycle to assess if the follicle reaches 17-19 mm

  11 days

• Change in Follicle growth and maturation at 5th month

  Transvaginal ultrasound will be done every 48 hours at the start from day 10 of the cycle to assess if the follicle reaches 17-19 mm

  11 days

Secondary Outcomes (1)

• Occurence of Chemical pregnancy occurence

  recorded at any time point during the study whenever occurs up to 5 months

Study Arms (2)

Vitamin D

ACTIVE COMPARATOR

Group V : number of 60 women will receive 100000 IU Cholecalciferol Intramuscular every month + 2000 mg Metformin (oral: 2 tablets 1000 per day) for 5 months . -after two months from the start: Clomiphene citrate 100mg (2 tablets clomid 50mg each per day,from 2nd to 6th day of the cycle ) will be added every month starting from the 3rd month to the 5th month .

Drug: Vit D; Drug: Metformin; Drug: Clomiphene

Control

PLACEBO COMPARATOR

Group C: number of 60 patients will receive Metformin 2000mg (oral: 2 tablets1000 mg per day) for months . -after two months from the start: Clomiphene citrate 100mg (2 tablets clomid 50mg each per day, from 2nd to 6th day of the cycle ) will be added every month starting from the 3rd month to the 5th month .

Drug: Metformin; Drug: Clomiphene

Interventions

Vit D DRUG

Injection

Also known as: Devarol-S

Vitamin D

Metformin DRUG

tablets

Also known as: Glucophage extended release

Control; Vitamin D

Clomiphene DRUG

Tablet

Also known as: Clomid

Control; Vitamin D

Eligibility Criteria

• Age: 20 Years - 35 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Diagnosis of PCOS as defined by the Rotterdam criteria
• Females age 20-35 years old
• BMI 18-30 kg/m2
• ry or secondary infertility
• Clomiphene resistant ( patients didn't - show response: ovulate to dose of 200 mg clomid per day for 3 cycles )
• Willingness to comply with study protocol for 5 months
• Willingness to give written informed consent to participate in the study

You may not qualify if:

• Previous metformin intake
• ovarian drilling
• tubal factor as evidenced by hysterosalpingogram or laparoscope
• endometrial pathology ex., polyp
• Myometrial pathology ex., adenomyosis or fibroid
• abnormal semen parameters
• Cushing syndrome
• Hyperprolactinemia
• Adrenal secreting tumor

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain Shams University Maternity hospital

Cairo, Egypt

Location

MeSH Terms

Conditions

Vitamin D Deficiency

Interventions

Metformin; Clomiphene

Condition Hierarchy (Ancestors)

Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals; Stilbenes; Benzylidene Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Study Officials

• Reda MK Ghanem, Lecturer

  Obstetrics & Gynecology department Faculty of medicine, Ain shams University.

  STUDY DIRECTOR

• Ahmed MN Hashaad, Professor

  Obstetrics & Gynecology department - Faculty of medicine, Ain shams University.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: July 2, 2019
• First Posted: July 8, 2019
• Study Start: April 1, 2018
• Primary Completion: December 30, 2018
• Study Completion: March 30, 2019
• Last Updated: July 8, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Within 9 months of study completion
• Access Criteria: Requestors should sign a data access agreement. And requests will be revised

Locations

EG (1)