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

NCT ID: NCT04916925

Last Updated: 2021-06-08

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-08-21
• Study Completion Date: 2021-12-01

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.

Conditions

Vitamin D Deficiency; Clomiphene Allergy; Polycystic Ovary Syndrome

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

Vitamin D

Intervention Type: DRUG

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

Intervention Type: DRUG

CLOMID is adrug used for ovulation induction

Interventions

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.

Intervention Type: DRUG

Clomid

CLOMID is adrug used for ovulation induction

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Ain Shams University

OTHER

Sponsor Role: collaborator

rana alaaeldin aly ibrahim nasr

OTHER

Sponsor Role: lead

Responsible Party

rana alaaeldin aly ibrahim nasr

Clinical gynecology professor

Responsibility Role: SPONSOR_INVESTIGATOR

Central Contacts

rana nasr

Role: CONTACT

roona_015@yahoo.com

01274901443

alhassan khedr

Role: CONTACT

alhassankhedr@med.asu.edu.eg

01006193797

Other Identifiers

PCOS resistant to CC & vit D

Identifier Type: -

Identifier Source: org_study_id