Status:
RECRUITING
Vitamin D and Endometrial Receptivity in Infertile Women
Lead Sponsor:
The University of Hong Kong
Conditions:
Infertility
Eligibility:
FEMALE
18-40 years
Brief 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.
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 sw...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 15 2021
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
August 1 2026
Estimated Enrollment :
105 Patients enrolled
Trial Details
Trial ID
NCT04721899
Start Date
January 15 2021
End Date
August 1 2026
Last Update
May 14 2024
Active Locations (1)
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1
Queen Mary Hospital
Hong Kong, Hong Kong, 000000