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

• Sponsor: rana alaaeldin aly ibrahim nasr (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT04916925
• Collaborator: Ain Shams University (Other)
• Enrollment: 100
• Arm: 1
• Anticipated Duration (Months): 3.4

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Vitamin D Deficiency; Clomiphene Allergy; Polycystic Ovary Syndrome	Drug: Vitamin D; Drug: Clomid	Phase 1/Phase 2

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 100 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Intervention Model Description: a single arm clinical traila single arm clinical trail
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Effect of Vitamin D Oral Supplementation in Poly Cystic Ovarian Women Resistant to Clomiphene Citrate
• Anticipated Study Start Date: Aug 21, 2021
• Anticipated Primary Completion Date: Sep 1, 2021
• Anticipated Study Completion Date: Dec 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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	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.; Drug: Clomid; CLOMID is adrug used for ovulation induction

Outcome Measures

Primary Outcome Measures

1. 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

1. pregancy rate [2 days after delayed menses]

   Pregnancy test positive by quantititave see beta HCG level

2. Evaluation of the endometrial thickness [36 hour of taking HCG]

   Measure the endometrium thickness by transvaginal ultrasound

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 40 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• rana alaaeldin aly ibrahim nasr
• Ain Shams University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: rana alaaeldin aly ibrahim nasr, Clinical gynecology professor, Ain Shams University
• ClinicalTrials.gov Identifier: NCT04916925
• Other Study ID Numbers: PCOS resistant to CC & vit D
• First Posted: Jun 8, 2021
• Last Update Posted: Jun 8, 2021
• Last Verified: Jun 1, 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by rana alaaeldin aly ibrahim nasr, Clinical gynecology professor, Ain Shams University: Poly cystic ovary syndrome; Vitamin D
• Additional relevant MeSH terms: Polycystic Ovary Syndrome; Vitamin D Deficiency; Vitamin D

Study Results

No Results Posted as of Jun 8, 2021