Vitamin D DeficiencyPhase 1/2NCT04916925
Effect of Vitamin D Oral Supplementation in Poly Csytic Ovarian Women Resistant to Clomiphene Citrate
A Phase 1/2 study testing Vitamin D and Clomid in people with Vitamin D Deficiency and Clomiphene Allergy, run by rana alaaeldin aly ibrahim nasr.
Trial summary
effect of vitamin D oral supplementation in poly csytic ovarian women resistant to clomiphene citrate Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Vitamin D Deficiency, Clomiphene Allergy, Polycystic Ovary Syndrome
- What is being tested?
- Vitamin D and Clomid
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 21 Aug 2021to 1 Dec 2021
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age: 18-40 years 2- Polycystic ovarian syndrome diagnosis made according to ESHRE/ASRM criteria.
- Polycystic ovaries (either 12 or more follicles or increased ovarian volume [> 10 cm3
- Oligo-ovulation or anovulation
- 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
Who cannot join
- Causes of infertility other than PCOS.
- Male factor.(normal semen analysis)
- Other factors e.g. endometriosis
- Tubal factor. (normal hysterosalpingography)
- Premature ovarian failure: Day 3 FSH > 14 mlu/ml or antimullerian hormone <1 ng/ml.
- Normal ultrasound except for criteria of PCO
Show all 10Show fewer
- 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 locations and contacts
No sites are listed yet.
About this study
Official title: Effect of Vitamin D Oral Supplementation in Poly Cystic Ovarian Women Resistant to Clomiphene Citrate
effect of vitamin D oral supplementation in poly csytic ovarian women resistant to clomiphene citrate
Read the 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.
- Being tested
- Vitamin D, Clomid
- Keywords
- Poly cystic ovary syndrome, Vitamin D
- Medical subject headings
- Vitamin D Deficiency, Polycystic Ovary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin DDrug
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.
ClomidDrug
CLOMID is adrug used for ovulation induction
| Study group | Role | What they receive |
|---|---|---|
| pcos resistant to cc plus vit d | Experimental | 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 Receives: Drug: Vitamin D; Drug: Clomid |
What is being measured
The primary outcome is the main question the study is designed to answer.
number of the ovulated follicles
Number of ovulated follicles by trans vaginal ultra sound signs of ovulation
Measured: 36 hours of taking HCG injection
Secondary outcomes (2)
pregancy rate
Pregnancy test positive by quantititave see beta HCG level
Measured: 2 days after delayed menses
Evaluation of the endometrial thickness
Measure the endometrium thickness by transvaginal ultrasound
Measured: 36 hour of taking HCG
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2021
- Study start21 Aug 2021 (estimated)
- Primary completion1 Sep 2021 (estimated)
- Study completion1 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vitamin D DeficiencyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- a single arm clinical trail
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- rana alaaeldin aly ibrahim nasr
- Sponsor type
- University, hospital or other
- Collaborators
- Ain Shams University
- Responsible party
- Sponsor-investigator, rana alaaeldin aly ibrahim nasr, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04916925
- Sponsor's protocol ID
- PCOS resistant to CC & vit D
- Status last verified
- Jun 2021
- First submitted
- 21 Jul 2019
- Last updated
- 8 Jun 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Vitamin D Oral Supplementation in Poly Cystic Ovarian Women Resistant to Clomiphene Citrate
- ClinicalTrials.gov ID
- NCT04916925
- Acronym / sponsor ID
- PCOS resistant to CC & vit D
- Keywords
- Poly cystic ovary syndrome, Vitamin D
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- rana alaaeldin aly ibrahim nasrUniversity, hospital or other
- Collaborators
- Ain Shams University
- Study start
- 21 Aug 2021 (estimated)
- Primary completion
- 1 Sep 2021 (estimated)
- Study completion
- 1 Dec 2021 (estimated)
- First posted
- 8 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- a single arm clinical trail
| Arm | Type | Receives |
|---|---|---|
| pcos resistant to cc plus vit d | Experimental | Drug: Vitamin D, Drug: Clomid100 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 |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Age: 18-40 years 2- Polycystic ovarian syndrome diagnosis made according to ESHRE/ASRM criteria.
Key exclusion criteria (10 listed)
- Causes of infertility other than PCOS.
- Causes of anovulation other than PCOS.
- Patients with hyperprolactinemia
- Patients with thyroid dysfunction.
- Current or in last six months use of vit D treatment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vitamin DAdding 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 | pcos resistant to cc plus vit d |
| ClomidCLOMID is adrug used for ovulation induction | Drug | pcos resistant to cc plus vit d |
Primary outcome
number of the ovulated follicles
Time frame: 36 hours of taking HCG injection
Number of ovulated follicles by trans vaginal ultra sound signs of ovulation
2 secondary outcomes
pregancy rate
Time frame: 2 days after delayed menses
Evaluation of the endometrial thickness
Time frame: 36 hour of taking HCG
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Vitamin D and Clomid in people with Vitamin D Deficiency and Clomiphene Allergy, run by rana alaaeldin aly ibrahim nasr.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact rana nasr (01274901443, roona_015@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
number of the ovulated follicles (time frame: 36 hours of taking HCG injection). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2021.