- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04721899
Vitamin D and Endometrial Receptivity in Infertile Women
Effect of Vitamin D on Vaginal / Endometrial Biomarkers and Endometrial Receptivity in Women With Fertility Problems
Study Overview
Detailed Description
The aim of this study is to assess the effect of vitamin D supplementation on vaginal / endometrial biomarkers and endometrial receptivity in women with fertility problems.
Women will have vaginal swab and endometrial biopsy twice. The first endometrial biopsy is performed using a Pipelle sampler 7 days after luteinizing hormone surge (LH+7) at baseline and the attachment rate of the trophoblast spheroid onto the isolated endometrial epithelial cells will be assessed to assess endometrial receptivity at baseline. Implantation biomarkers will be checked.
They will take Vitamin D 50,000 IU once per week for 4 weeks, followed by 50,000 IU once every 2 weeks for 4 weeks. After 8 weeks of Vitamin D, a second vaginal swab and endometrial biopsy using a Pipelle sampler by standard technique will be collected from the patients 7 days after luteinizing hormone surge (LH+7) and the endometrial receptivity will be compared.
The laboratory staff will not know whether the patient is taking any vitamin D when performing the trophoblast spheroid attachment assay/ biomarkers.
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Jennifer KY Ko
- Phone Number: 22554647
- Email: jenko@hku.hk
Study Locations
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Hong Kong, Hong Kong, 000000
- Recruiting
- Queen Mary Hospital
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Contact:
- Jennifer KY Ko, MBBS, MRCOG
- Phone Number: 22554647
- Email: jenko@hku.hk
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Age of women < 40years old
- Normal uterine cavity as demonstrated by pelvic scanning with or without saline infusion sonogram or hysteroscopy
- Regular ovulatory cycles
They will be divided into three groups:
- RIF patients (n=35)- those who have failed to get pregnant after replacing four or more cleavage stage embryos or two or more blastocysts in two consecutive transfers.
- RPL patients (n=35)- those who have failed in three pregnancies before 24 weeks of gestation and includes embryonic and fetal losses.
- 'Infertile group'(n=35)- infertility except RIF and RPL, e.g. those seeking for preimplantation genetic testing, male factor infertility, unexplained infertility.
Exclusion Criteria:
- History of any medical condition or medications that may predispose to vitamin D sensitivity, altered vitamin D metabolism and/ or hypercalcemia, including active tuberculosis or current therapy for tuberculosis, sarcoidosis, history of renal/ ureteral stones, parathyroid disease, renal or liver failure or current use of anti-convulsants
- Taking vitamin D supplement
- Endometrial polyp or fibroid distorting the uterine cavity
- Presence of hydrosalpinx not corrected surgically
Refusal to join the study
• Discontinuation criteria-
- If the woman becomes pregnant during the study
- Pelvic inflammatory disease/ uterine perforation after endometrial biopsy
- Vitamin D toxicity (hypercalcemia)
- Withdrawal by patient
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Vitamin D- recurrent implantation failure (RIF)
All women will have endometrial biopsy twice- at baseline and after 8 weeks of taking vitamin D After 8 weeks of Vitamin D, a second endometrial biopsy using a Pipelle sampler will be collected from the patients 7 days after luteinizing hormone surge (LH+7) and the endometrial receptivity will be compared.
|
Vitamin D 50,000 IU once per week for 4 weeks, followed by 50,000 IU once every 2 weeks for 4 weeks
|
Vitamin D- recurrent pregnancy loss (RPL)
All women will have endometrial biopsy twice- at baseline and after 8 weeks of taking vitamin D After 8 weeks of Vitamin D, a second endometrial biopsy using a Pipelle sampler will be collected from the patients 7 days after luteinizing hormone surge (LH+7) and the endometrial receptivity will be compared.
|
Vitamin D 50,000 IU once per week for 4 weeks, followed by 50,000 IU once every 2 weeks for 4 weeks
|
Vitamin D- infertility
All women will have endometrial biopsy twice- at baseline and after 8 weeks of taking vitamin D After 8 weeks of Vitamin D, a second endometrial biopsy using a Pipelle sampler will be collected from the patients 7 days after luteinizing hormone surge (LH+7) and the endometrial receptivity will be compared.
|
Vitamin D 50,000 IU once per week for 4 weeks, followed by 50,000 IU once every 2 weeks for 4 weeks
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in endometrial receptivity
Time Frame: 8 weeks
|
Assessed by the attachment rate of trophoblast spheroid attachment assay onto the isolated endometrial epithelial cells
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8 weeks
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- UW19-134
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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