Vitamin D and Endometrial Receptivity in Infertile Women

Last updated: May 13, 2024
Sponsor: The University of Hong Kong
Overall Status: Active - Recruiting

Phase

N/A

Condition

Infertility

Treatment

Vitamin D

Clinical Study ID

NCT04721899
UW19-134
  • Ages 18-40
  • Female

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Age of women < 40years old

  • Normal uterine cavity as demonstrated by pelvic scanning with or without salineinfusion 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 ormore 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 ofgestation and includes embryonic and fetal losses.

  • 'Infertile group'(n=35)- infertility except RIF and RPL, e.g. those seeking forpreimplantation genetic testing, male factor infertility, unexplained infertility.

Exclusion

Exclusion Criteria:

  • History of any medical condition or medications that may predispose to vitamin Dsensitivity, altered vitamin D metabolism and/ or hypercalcemia, including activetuberculosis or current therapy for tuberculosis, sarcoidosis, history of renal/ureteral stones, parathyroid disease, renal or liver failure or current use ofanti-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 Design

Total Participants: 105
Treatment Group(s): 1
Primary Treatment: Vitamin D
Phase:
Study Start date:
January 15, 2021
Estimated Completion Date:
August 01, 2026

Study 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.

Connect with a study center

  • Queen Mary Hospital

    Hong Kong, 000000
    Hong Kong

    Active - Recruiting

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