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

Vitamin D Deficiency Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04916925
• Other study ID #: PCOS resistant to CC & vit D
• Status: Not yet recruiting
• Phase: Phase 1/Phase 2
• Start date: August 21, 2021
• Est. completion date: December 1, 2021

Study information

• Verified date: June 2021
• Source: Ain Shams University
• Contact: rana nasr
• Phone: 01274901443
• Email: roona_015[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: December 1, 2021
• Est. primary completion date: September 1, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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.

Related Conditions & MeSH terms

• Polycystic Ovary Syndrome
• Vitamin D Deficiency

Intervention

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.
• Clomid
CLOMID is adrug used for ovulation induction

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
rana alaaeldin aly ibrahim nasr	Ain Shams University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	number of the ovulated follicles	Number of ovulated follicles by trans vaginal ultra sound signs of ovulation	36 hours of taking HCG injection
Secondary	pregancy rate	Pregnancy test positive by quantititave see beta HCG level	2 days after delayed menses
Secondary	Evaluation of the endometrial thickness	Measure the endometrium thickness by transvaginal ultrasound	36 hour of taking HCG