Ovulation InductionPhase 3NCT03396380
Effect of Vitamin D Supplement in Induction of Ovulation in Overweight Women With Polycystic Ovary Syndrome
A Phase 3 study testing Vitamin D with calcium and clomiphene citrate in people with Ovulation Induction, run by Ain Shams University at 1 site in Egypt.
Trial summary
The aim of this work is to evaluate the effect of vitamin D supplementation in overweight infertile women with PCOs undergoing induction of ovulation. Read more about this study
- Who is it for?
- Ages 25 to 35 years, women only
- Conditions the study is for
- Ovulation Induction
- What is being tested?
- Vitamin D with calcium and clomiphene citrate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 186 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jul 2017to 1 May 2018
- Phase
- Phase 3
- 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 25 to 35 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- polycystic ovarian syndrome diagnosis made according to ESHRE/ASRM criteria.
- infertility is the cause for seeking treatment.
- overweight females with BMI more than 25 but less than 30.
Who cannot join
- causes of infertility other than PCOS.
- causes of anovulation other than PCOS.
- current or in last six months use of hormonal treatment.
- contraindication to any drug used in the study.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
AinShams university maternity hospital
Cairo, Abbassya
Radwa R Ali, MD
About this study
Official title: Effect of Adding Vitamin D Supplement to Clomiphene Citrate for Induction of Ovulation in Overweight Women With Polycystic Ovary Syndrome
The aim of this work is to evaluate the effect of vitamin D supplementation in overweight infertile women with PCOs undergoing induction of ovulation.
Read the detailed description
The study will include overweight infertile women with PCOS seeking fertility who will receive induction of ovulation by clomiphene citrate will be recruited and randomized into two groups:
Group A (study group): 93 women who will receive clomiphene citrate for induction of ovulation with vitamin D and calcium supplement
Group B (control group): 93 women who will receive clomiphene citrate for induction of ovulation with placebo and calcium supplement
- Conditions
- Ovulation Induction
- Being tested
- Vitamin D with calcium and clomiphene citrate, Placebo Oral Tablet with calcium and clomiphene citrate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin D with calcium and clomiphene citrateDrug
- Vitamin D ( ossofortin®, EVA PHARMA) 10000 IU twice weekly and calcium (calciprex®, Marcyrl Pharmaceutical Industries ) 1250 mg twice daily which provide elemental calcium 500 mg/tablet for one month before induction of ovulation and both will be continued during the 3 induction cycles in the same regimen.
- Induction of ovulation by clomiphene citrate (Clomid®, Aventis) 50 mg tablet twice daily 12 hours apart (total dose 100 mg daily) starting from the third day of menstrual cycle and for five days .
Placebo Oral Tablet with calcium and clomiphene citrateDrug
- The placebo tablet twice weekly and calcium (calciprex®, Marcyrl Pharmaceutical Industries ) 1250 mg twice daily which provide elemental calcium 500 mg/tablet for one month before induction of ovulation and both will be continued during the 3 induction cycles in the same regimen.
- induction of ovulation by clomiphene citrate (Clomid®, Aventis) 50 mg tablet twice daily 12 hours apart (total dose 100 mg daily)starting from the 3rd day of menstrual cycle and for five days
| Study group | Role | What they receive |
|---|---|---|
| vitamin D | Active comparator | 93 women who will receive clomiphene citrate for induction of ovulation with vitamin D and calcium supplement Receives: Drug: Vitamin D with calcium and clomiphene citrate |
| placebo | Placebo comparator | 93 women who will receive clomiphene citrate for induction of ovulation with placebo and calcium supplement Receives: Drug: Placebo Oral Tablet with calcium and clomiphene citrate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of ovulation
- Transvaginal ultrasound will be done to detect signs of ovulation: corpus luteum, fluid in cul-de-sac, collapse of the follicle size.
- Serum progesterone will be measured in the mid luteal day of the cycle, where:
Level 19 nmol/L indicates Ovulation. Level <5 nmol/L suggests Ovulation did not occur
Measured: till cycle day 21 if not reaching more than 18 mm
Secondary outcomes (4)
Number of growing follicles.
to monitor induction
Measured: till cycle day 21 if not reaching more than 18 mm
Evaluation of the endometrial thickness
could be impaired with antiestrogenic effect of clomiphen citrate
Measured: in cycle day 14 and 21.
Pregnancy rates
both clinical and biochemical
Measured: pregnancy test 1 week after missed menses
Adverse effects
hot flashes, headache, nausea, vomiting, breast tenderness, blurred vision, abdominal distention and pain and ovarian enlargement or hyperstimulation.
Measured: for 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2018
- Study start1 Jul 2017
- Primary completion1 Mar 2018 (estimated)
- Study completion1 May 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Ovulation InductionStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 186 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Radwa Rasheedy Ali, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03396380
- Sponsor's protocol ID
- ain shams maternity hospital
- Status last verified
- Jan 2018
- First submitted
- 16 Dec 2017
- Last updated
- 11 Jan 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Rasheedy R, Sammour H, Elkholy A, Salim Y. The efficacy of vitamin D combined with clomiphene citrate in ovulation induction in overweight women with polycystic ovary syndrome: a double blind, randomized clinical trial. Endocrine. 2020 Aug;69(2):393-401. doi: 10.1007/s12020-020-02315-3. Epub 2020 May 3.
PubMed 32363556
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Adding Vitamin D Supplement to Clomiphene Citrate for Induction of Ovulation in Overweight Women With Polycystic Ovary Syndrome
- ClinicalTrials.gov ID
- NCT03396380
- Acronym / sponsor ID
- ain shams maternity hospital
- Conditions
- Ovulation Induction
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 186 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Jul 2017 (actual)
- Primary completion
- 1 Mar 2018 (estimated)
- Study completion
- 1 May 2018 (estimated)
- First posted
- 11 Jan 2018 (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.
The aim of this work is to evaluate the effect of vitamin D supplementation in overweight infertile women with PCOs undergoing induction of ovulation.
Detailed description
The study will include overweight infertile women with PCOS seeking fertility who will receive induction of ovulation by clomiphene citrate will be recruited and randomized into two groups:
Group A (study group): 93 women who will receive clomiphene citrate for induction of ovulation with vitamin D and calcium supplement
Group B (control group): 93 women who will receive clomiphene citrate for induction of ovulation with placebo and calcium supplement
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| vitamin D | Active comparator | Drug: Vitamin D with calcium and clomiphene citrate93 women who will receive clomiphene citrate for induction of ovulation with vitamin D and calcium supplement |
| placebo | Placebo comparator | Drug: Placebo Oral Tablet with calcium and clomiphene citrate93 women who will receive clomiphene citrate for induction of ovulation with placebo and calcium supplement |
Who may qualify
- Ages
- 25 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- polycystic ovarian syndrome diagnosis made according to ESHRE/ASRM criteria.
- infertility is the cause for seeking treatment.
- overweight females with BMI more than 25 but less than 30.
Key exclusion criteria (4 listed)
- causes of infertility other than PCOS.
- causes of anovulation other than PCOS.
- current or in last six months use of hormonal treatment.
- contraindication to any drug used in the study.
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 D with calcium and clomiphene citrate1. Vitamin D ( ossofortin®, EVA PHARMA) 10000 IU twice weekly and calcium (calciprex®, Marcyrl Pharmaceutical Industries ) 1250 mg twice daily which provide elemental calcium 500 mg/tablet for one month before induction of ovulation and both will be continued during the 3 induction cycles in the same regimen. 2. Induction of ovulation by clomiphene citrate (Clomid®, Aventis) 50 mg tablet twice daily 12 hours apart (total dose 100 mg daily) starting from the third day of menstrual cycle and for five days . | Drug | vitamin D |
| Placebo Oral Tablet with calcium and clomiphene citrate1. The placebo tablet twice weekly and calcium (calciprex®, Marcyrl Pharmaceutical Industries ) 1250 mg twice daily which provide elemental calcium 500 mg/tablet for one month before induction of ovulation and both will be continued during the 3 induction cycles in the same regimen. 2. induction of ovulation by clomiphene citrate (Clomid®, Aventis) 50 mg tablet twice daily 12 hours apart (total dose 100 mg daily)starting from the 3rd day of menstrual cycle and for five days | Drug | placebo |
Primary outcome
Rate of ovulation
Time frame: till cycle day 21 if not reaching more than 18 mm
* Transvaginal ultrasound will be done to detect signs of ovulation: corpus luteum, fluid in cul-de-sac, collapse of the follicle size. * Serum progesterone will be measured in the mid luteal day of the cycle, where: Level 19 nmol/L indicates Ovulation. Level <5 nmol/L suggests Ovulation did not occur
4 secondary outcomes
Number of growing follicles.
Time frame: till cycle day 21 if not reaching more than 18 mm
Evaluation of the endometrial thickness
Time frame: in cycle day 14 and 21.
Pregnancy rates
Time frame: pregnancy test 1 week after missed menses
Adverse effects
Time frame: for 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2018.
- Derived from this study: PubMed 32363556Rasheedy R, Sammour H, Elkholy A, Salim Y. The efficacy of vitamin D combined with clomiphene citrate in ovulation induction in overweight women with polycystic ovary syndrome: a double blind, randomized clinical trial. Endocrine. 2020 Aug;69(2):393-401. doi: 10.1007/s12020-020-02315-3. Epub 2020 May 3.
Related trials for Ovulation Induction
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LE + CC vs. LE for Ovulation Induction
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Not yet recruiting
Oral GnRH Antagonist (Linzagolix) Versus Injectable GnRH Antagonist in Controlled Ovarian Stimulation for In Vitro Fertilization: A Randomized Controlled Non-Inferiority Trial With a Concurrent Comparator Cohort Undergoing Progestin-Primed Ovarian Stimulation (PPOS)
Infertility, Female, Ovulation Induction
RecruitingPhase 1
E.N.D.E.A.V.O.R.: An Exemestane Needed Dose Efficacy and Verification as an Ovulation Induction Regimen Study
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RecruitingPhase 4
Progesterone Supplementation After Letrozole-stimulated Insemination
Infertility
RecruitingPhase 2/3
Autologous Platelet Rich Plasma Intraovarian Infusion for Poor Responders
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Vitamin D with calcium and clomiphene citrate in people with Ovulation Induction, run by Ain Shams University at 1 site in Egypt.
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 3 inclusion and 4 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 11 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 Radwa R Ali (01283492979 ext. 02002, radwaebed@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of ovulation (time frame: till cycle day 21 if not reaching more than 18 mm). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03396380, which also lists 1 linked publication.
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 11 Jan 2018.