Vitamin D and Endometrial Receptivity in Infertile Women

May 28, 2021 updated by: The University of Hong Kong

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Observational

Enrollment (Anticipated)

105

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Jennifer KY Ko
  • Phone Number: 22554647
  • Email: jenko@hku.hk

Study Locations

      • Hong Kong, Hong Kong, 000000
        • Recruiting
        • Queen Mary Hospital
        • Contact:
          • Jennifer KY Ko, MBBS, MRCOG
          • Phone Number: 22554647
          • Email: jenko@hku.hk

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

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.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 15, 2021

Primary Completion (Anticipated)

February 1, 2022

Study Completion (Anticipated)

August 1, 2022

Study Registration Dates

First Submitted

January 19, 2021

First Submitted That Met QC Criteria

January 19, 2021

First Posted (Actual)

January 25, 2021

Study Record Updates

Last Update Posted (Actual)

June 3, 2021

Last Update Submitted That Met QC Criteria

May 28, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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