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

Phase 1

• Conditions: Vitamin D Deficiency; Polycystic Ovary Syndrome; Clomiphene Allergy
• Interventions: Drug: Vitamin D; Drug: Clomid

• Registration Number: NCT04916925
• Lead Sponsor: rana alaaeldin aly ibrahim nasr

Brief Summary

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

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 Timeline

• Study First Submitted: 2019-07-21
• Status Verified: 2021-06
• Study First Submitted QC: 2021-06-01
• Last Update Submitted: 2021-06-01
• Study First Posted: 2021-06-08
• Last Update Posted: 2021-06-08
• Study Start: 2021-08-21
• Primary Completion: 2021-09-01
• Study Completion: 2021-12-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 100

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
pcos resistant to cc plus vit d	Vitamin 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
pcos resistant to cc plus vit d	Clomid	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

Primary Outcome Measures

Name	Time	Method
number of the ovulated follicles	36 hours of taking HCG injection	Number of ovulated follicles by trans vaginal ultra sound signs of ovulation

Secondary Outcome Measures

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