Clinical trial NCT04916925: Effect of Vitamin D Oral Supplementation in Poly Csytic Ovarian Women Resistant to Clomiphene Citrate
Official title: Effect of Vitamin D Oral Supplementation in Poly Cystic Ovarian Women Resistant to Clomiphene Citrate
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Vitamin D Deficiency
Clomiphene Allergy
Polycystic Ovary Syndrome
Keywords: Poly cystic ovary syndrome
Vitamin D
Lead sponsor: Ain Shams University
Sponsor class: OTHER
Collaborators: name: Ain Shams University
First posted: 2021-06-08
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: a single arm clinical trail
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: number of the ovulated follicles
timeFrame: 36 hours of taking HCG injection
Secondary outcomes:
measure: pregancy rate
timeFrame: 2 days after delayed menses
measure: Evaluation of the endometrial thickness
timeFrame: 36 hour of taking HCG
Other outcomes:
Locations:
Study officials:
References: