InfertilityNCT04721899
Vitamin D and Endometrial Receptivity in Infertile Women
An observational study of Infertility, run by The University of Hong Kong at 1 site in Hong Kong.
Trial summary
This is a prospective study comparing vaginal and endometrial biomarkers and the trophoblast spheroid attachment rate in women with fertility problems before and after taking Vitamin D for 8 weeks. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Infertility
- What is being tested?
- Vitamin D
- How many people
- 105 participants
- Where
- 1 siteHong Kong
- Study dates
- 15 Jan 2021to 1 Aug 2026
- Phase
- Observational
- 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
- No healthy volunteers
- Adult
Study population: Patients will be recruited from the Centre of Assisted Reproduction and Embryology, the University of Hong Kong at Queen Mary Hospital. Infertile women who are in the waiting list for IVF or have failed one IVF cycle will be recruited.
Who may be able to join
- 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.
Who cannot join
- 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-
Show all 10Show fewer
- If the woman becomes pregnant during the study
- Pelvic inflammatory disease/ uterine perforation after endometrial biopsy
- Vitamin D toxicity (hypercalcemia)
- Withdrawal by patient
Trial locations and contacts
1 site in 1 country.
Hong Kong1 site, 1 recruiting
- Recruiting
Queen Mary Hospital
Hong Kong, 000000
Jennifer KY Ko, MBBS, MRCOG, 22554647, jenko@hku.hk
About this study
Official title: Effect of Vitamin D on Vaginal / Endometrial Biomarkers and Endometrial Receptivity in Women With Fertility Problems
This is a prospective study comparing vaginal and endometrial biomarkers and the trophoblast spheroid attachment rate in women with fertility problems before and after taking Vitamin D for 8 weeks.
Read the 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.
- Conditions
- Infertility
- Being tested
- Vitamin D
- Keywords
- vitamin D, endometrial receptivity, infertility, recurrent pregnancy loss, recurrent implantation failure
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin DDietary supplement
Vitamin D 50,000 IU once per week for 4 weeks, followed by 50,000 IU once every 2 weeks for 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Dietary Supplement: Vitamin D | |
| 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. Receives: Dietary Supplement: Vitamin D | |
| 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. Receives: Dietary Supplement: Vitamin D |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in endometrial receptivity
Assessed by the attachment rate of trophoblast spheroid attachment assay onto the isolated endometrial epithelial cells
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2021
- Study start15 Jan 2021
- Primary completion1 Feb 2025 (estimated)
- Study completion1 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfertilityStudies of the same condition, open and under way.
- More trials run by The University of Hong KongThe 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 105 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04721899
- Sponsor's protocol ID
- UW19-134
- Status last verified
- May 2024
- First submitted
- 19 Jan 2021
- Last updated
- 14 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Vitamin D on Vaginal / Endometrial Biomarkers and Endometrial Receptivity in Women With Fertility Problems
- ClinicalTrials.gov ID
- NCT04721899
- Acronym / sponsor ID
- UW19-134
- Conditions
- Infertility
- Keywords
- vitamin D, endometrial receptivity, infertility, recurrent pregnancy loss, recurrent implantation failure
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 105 participants (estimated)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Study start
- 15 Jan 2021 (actual)
- Primary completion
- 1 Feb 2025 (estimated)
- Study completion
- 1 Aug 2026 (estimated)
- First posted
- 25 Jan 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.
This is a prospective study comparing vaginal and endometrial biomarkers and the trophoblast spheroid attachment rate in women with fertility problems before and after taking Vitamin D for 8 weeks.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Vitamin D- recurrent implantation failure (RIF) | – | Dietary Supplement: Vitamin DAll 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- recurrent pregnancy loss (RPL) | – | Dietary Supplement: Vitamin DAll 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- infertility | – | Dietary Supplement: Vitamin DAll 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. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Patients will be recruited from the Centre of Assisted Reproduction and Embryology, the University of Hong Kong at Queen Mary Hospital. Infertile women who are in the waiting list for IVF or have failed one IVF cycle will be recruited.
Key inclusion criteria (7 listed)
- Age of women < 40years old
- Normal uterine cavity as demonstrated by pelvic scanning with or without saline infusion sonogram or hysteroscopy
- Regular ovulatory cycles
- 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.
Key exclusion criteria (10 listed)
- 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
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 DVitamin D 50,000 IU once per week for 4 weeks, followed by 50,000 IU once every 2 weeks for 4 weeks | Dietary supplement | Vitamin D- infertility, Vitamin D- recurrent implantation failure (RIF), Vitamin D- recurrent pregnancy loss (RPL) |
Primary outcome
Change in endometrial receptivity
Time frame: 8 weeks
Assessed by the attachment rate of trophoblast spheroid attachment assay onto the isolated endometrial epithelial cells
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2024.
- Individual participant dataSharing planned: Undecided
Related trials for Infertility
RecruitingObservational study
International Pilot Study for Dual Non-invasive Assesment of Embryo Development
Infertility
Active, not recruitingObservational study
Retrieval of Sperm From Men With Azoospermia Using Ultrasound-guided Rete Testis Aspiration
Azoospermia, Nonobstructive, Infertility, Male
Not yet recruiting
Spinery Basivertebral Nerve Ablation for Vertebrogenic Chronic Low Back Pain
Low Back Pain, Chronic Low Back Pain (CLBP)
RecruitingObservational study
Impact of Infertility on the Sexual Sphere in Couples Undergoing Assisted Reproduction
Sexual Health Quality of Life, Infertile Patients
RecruitingObservational study
Pilot Study of Discarded Blastocysts
Infertility (IVF Patients)
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?
An observational study of Infertility, run by The University of Hong Kong at 1 site in Hong Kong.
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 7 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 14 May 2024. 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 Hong Kong. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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 Jennifer KY Ko (22554647, jenko@hku.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in endometrial receptivity (time frame: 8 weeks). 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 14 May 2024.