Vitamin D and Endometrial Receptivity in Infertile Women

NCT04721899 | Recruiting

• 1 other identifier: UW19-134
• Study Type: observational
• Target: 105
• Locations: 1 country
• Sites: 1

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.

Conditions

Infertility

Keywords

vitamin D; endometrial receptivity; infertility; recurrent pregnancy loss; recurrent implantation failure

Outcome Measures

Primary Outcomes (1)

• Change in endometrial receptivity

  Assessed by the attachment rate of trophoblast spheroid attachment assay onto the isolated endometrial epithelial cells

  8 weeks

Study Arms (3)

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.

Dietary Supplement: Vitamin D

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.

Dietary Supplement: Vitamin D

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.

Dietary Supplement: Vitamin D

Interventions

Vitamin D DIETARY_SUPPLEMENT

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; Vitamin D- recurrent implantation failure (RIF); Vitamin D- recurrent pregnancy loss (RPL)

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• The University of Hong Kong: lead

Study Sites (1)

Queen Mary Hospital

Hong Kong, 000000, Hong Kong

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

endometrial biopsy

MeSH Terms

Conditions

Infertility

Interventions

Vitamin D

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Secosteroids; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Central Study Contacts

Jennifer KY Ko

CONTACT

22554647; jenko@hku.hk

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 19, 2021
• First Posted: January 25, 2021
• Study Start: January 15, 2021
• Primary Completion: February 1, 2025
• Study Completion (Estimated): August 1, 2026
• Last Updated: May 14, 2024

Record last verified: 2024-05

Locations

HK (1)