Vitamin D and Endometrial Receptivity in Infertile Women

Infertility Clinical Trial

Official title:

Effect of Vitamin D on Vaginal / Endometrial Biomarkers and Endometrial Receptivity in Women With Fertility Problems

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04721899
• Other study ID #: UW19-134
• Status: Recruiting
• Start date: January 15, 2021
• Est. completion date: August 1, 2026

Study information

• Verified date: May 2024
• Source: The University of Hong Kong
• Contact: Jennifer KY Ko
• Phone: 22554647
• Email: jenko[@]hku.hk
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 105
• Est. completion date: August 1, 2026
• Est. primary completion date: February 1, 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Infertility

Intervention

Dietary Supplement:
• Vitamin D
Vitamin D 50,000 IU once per week for 4 weeks, followed by 50,000 IU once every 2 weeks for 4 weeks

Locations

Country	Name	City	State
Hong Kong	Queen Mary Hospital	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
The University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in endometrial receptivity	Assessed by the attachment rate of trophoblast spheroid attachment assay onto the isolated endometrial epithelial cells	8 weeks