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OpenTrials
Completed

NCT Number: NCT02656121

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

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

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Key information

Conditions

PCOS Adnexal Diseases Cysts Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Gonadal Disorders Neoplasms Ovarian Cysts Ovarian Diseases Polycystic Ovary Syndrome Urogenital Diseases

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Faculty of Medicine, Ain Shams University

Cairo, Cairo Governorate, Egypt

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Vitamin D

Drug

6000 IU of vitamin D3

Other names: Vidrop®, Medical Union Pharmaceuticals, Egypt

Ovulatory Agent

Drug

only Clomophine Citrate

Other names: Clomiphene Citrate for induction of ovulation

Primary outcomes

  1. cumulative clomiphene citrate-induced ovulation rates

    Time frame: 6 months

    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 outcomes

  1. Cumlative clinical pregnancy rate

    Time frame: 6 months

    detection of fetal heart activity detected by transvaginal ultrasound

  2. median ovulating dose of clomiphene citrate

    Time frame: 6 months

    Dose required

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Acronym: PCOSD

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Jan 14, 2016
Registry last updated
Nov 16, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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