Effect of Vitamin D Oral Supplementation in Poly Csytic Ovarian Women Resistant to Clomiphene Citrate

Effect of Vitamin D Oral Supplementation in Poly Cystic Ovarian Women Resistant to Clomiphene Citrate

effect of vitamin D oral supplementation in poly csytic ovarian women resistant to clomiphene citrate

Study Overview

• Status: Not yet recruiting
• Conditions: Polycystic Ovary Syndrome; Vitamin D Deficiency; Clomiphene Allergy
• Intervention / Treatment: Drug: Vitamin D; Drug: Clomid

Detailed Description

Polycystic ovarian syndrome is the most common endocrine disorder . It is associated with chronic anovulation and infertility. The diagnosis is made by clinical and ancillary investigations revealing the presence of irregular menstrual cycles, an ovulation , Hyperandrgenemia , and the presence of polycystic ovaries (ovarian morphology as the presence of 12 or more follicles measuring 2-9 mm in diameter and an increased ovarian volume >10 cm 3) ovulation can be induced with clomiphene citrate (CC), However, ~20%-25% of anovulatory women with PCOS do not respond to CC and are considered to be "clomiphene-resistant( clomiphene citrate resistance means failure to ovulate with 3 months use of clomid at 150 mg/day for 5 days ) Vitamin D may serve as a key in preventing and attenuating the insulin resistance. Vitamin D plays a physiologic role in reproduction including ovarian follicular development and luteinisation, follicle-stimulating hormone sensitivity and progesterone production in human granulosa cells. It also affects glucose homeostasis .

In this trial 100 women with PCO disease that diagnosed by ROTTERDAM CRITERIA (must have any TWO of This findings: Hyperandrogenism, Oligomenorrhea, Polycystic ovaries). Who are taking clomiphene citrate for induction of ovulation and resistant to it, which means failure to ovulate with 3 months of usage of clomid at 150 mg/day for 5 days. They will recieve vitamin D (ossofortin®, Eva Pharma) orally 10000 IU twice weekly for other three months period with clomiphene citrate orally 150 mg/day for 5 days. Number and size of the growing follicles will be monitored before and after taking vitamin D by trans-vaginal ultrasound at day11-14 of the cycle till day 21 to detect effect of vitamin D in ovulation rate.

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: rana nasr; Phone Number: 01274901443; Email: roona_015@yahoo.com
• Study Contact Backup: Name: alhassan khedr; Phone Number: 01006193797; Email: alhassankhedr@med.asu.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Age: 18-40 years 2- Polycystic ovarian syndrome diagnosis made according to ESHRE/ASRM criteria.

  1. Polycystic ovaries (either 12 or more follicles or increased ovarian volume [> 10 cm3
  2. Oligo-ovulation or anovulation
  3. Clinical and/or biochemical signs of hyperandrogenism (Azziz, 2006). 3- PCOS infertile women resistant to CC for 3 cycles. clomiphene citrate resistance means failure to ovulate with 3 months use of clomid at 150 mg/day for 5 days

Exclusion Criteria:

• Causes of infertility other than PCOS.

  1. Male factor.(normal semen analysis)
  2. Other factors e.g. endometriosis
  3. Tubal factor. (normal hysterosalpingography)
  4. Premature ovarian failure: Day 3 FSH > 14 mlu/ml or antimullerian hormone <1 ng/ml.
  5. Normal ultrasound except for criteria of PCO
• Causes of anovulation other than PCOS.
• Patients with hyperprolactinemia
• Patients with thyroid dysfunction.
• Current or in last six months use of vit D treatment.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: pcos resistant to cc plus vit d; 100 patients who are PCOS and resist CC will receive Vitamin D 10000 IU orally plus 150mg clomid orally for 3 months number and size of growing follicles will be monitored	Drug: Vitamin D; Adding vitamin D to PCOS patients who are resistant to clomiphene regime for induction will or not improve the Clinical pregnancy rate and will or not increase chances of ovulation and pregnancy.; Drug: Clomid; CLOMID is adrug used for ovulation induction

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
number of the ovulated follicles	Number of ovulated follicles by trans vaginal ultra sound signs of ovulation	36 hours of taking HCG injection

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
pregancy rate	Pregnancy test positive by quantititave see beta HCG level	2 days after delayed menses
Evaluation of the endometrial thickness	Measure the endometrium thickness by transvaginal ultrasound	36 hour of taking HCG

Collaborators and Investigators

• Sponsor: rana alaaeldin aly ibrahim nasr
• Collaborators: Ain Shams University

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): August 21, 2021
• Primary Completion (ANTICIPATED): September 1, 2021
• Study Completion (ANTICIPATED): December 1, 2021

Study Registration Dates

• First Submitted: July 21, 2019
• First Submitted That Met QC Criteria: June 1, 2021
• First Posted (ACTUAL): June 8, 2021

Study Record Updates

• Last Update Posted (ACTUAL): June 8, 2021
• Last Update Submitted That Met QC Criteria: June 1, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Keywords: Vitamin D; Poly cystic ovary syndrome
• Additional Relevant MeSH Terms: Neoplasms; Endocrine System Diseases; Ovarian Cysts; Cysts; Ovarian Diseases; Adnexal Diseases; Gonadal Disorders; Nutrition Disorders; Avitaminosis; Deficiency Diseases; Malnutrition; Polycystic Ovary Syndrome; Vitamin D Deficiency; Physiological Effects of Drugs; Micronutrients; Vitamins; Bone Density Conservation Agents; Vitamin D
• Other Study ID Numbers: PCOS resistant to CC & vit D

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No