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

rana alaaeldin aly ibrahim nasr

Status and phase: Unknown; Phase 2; Phase 1

Conditions: Vitamin D Deficiency; Polycystic Ovary Syndrome; Clomiphene Allergy

Treatments: Drug: Clomid; Drug: Vitamin D

Study type: Interventional

Funder types: Other

Identifiers

NCT04916925

PCOS resistant to CC & vit D

Details and patient eligibility

About

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

Full 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.

Enrollment: 100 estimated patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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100 participants in 1 patient group

pcos resistant to cc plus vit d

Experimental group

Description:

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

Treatment:

Drug: Clomid

Drug: Vitamin D