RecruitingNCT04721899

Vitamin D and Endometrial Receptivity in Infertile Women

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


Sponsor

The University of Hong Kong

Enrollment

105 participants

Start Date

Jan 15, 2021

Study Type

OBSERVATIONAL

Conditions

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

Sex: FEMALEMin Age: 18 YearsMax Age: 40 Years

Inclusion Criteria7

  • 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 Criteria10

  • 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

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Interventions

DIETARY_SUPPLEMENTVitamin 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(1)

Queen Mary Hospital

Hong Kong, Hong Kong

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NCT04721899


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