Vitamin D and Pregnancy Outcome in PCOS Patients

NCT04082650 | Completed DMC

• 1 other identifier: VDPI
• Study Type: interventional
• Target: 876
• Locations: 1 country
• Sites: 2

Brief Summary

This multicenter double-blinded placebo-controlled randomised trial aims to evaluate the effectiveness of vitamin D supplementation prior to IVF on the live birth rate in women with PCOS. Women with PCOS scheduled for IVF will be enrolled. Eligible participants will be randomised 1:1 to receive oral capsules of 4000IU vitamin D per day or placebo for around 12 weeks until the day of triggering.

Conditions

Polycystic Ovary Syndrome; in Vitro Fertilization

Keywords

Polycystic Ovary Syndrome; in vitro fertilization; Vitamin D; randomized trial

Outcome Measures

Primary Outcomes (1)

• Number of Participants with live birth

  The primary outcome is live birth after the first embryo transfer. Live birth is defined as the delivery of at least one baby after 24 weeks of gestation that exhibits any sign of life.

  1 day after delivery

Secondary Outcomes (20)

• Number of Participants with Cumulative live birth

  6 months after randomization of the last participant

• Number of Participants with Clinical pregnancy

  4 weeks after embryo transfer

• birth weight

  The day of delivery

• Number of Participants with miscarriage

  24 gestational weeks in maximum

• Number of Participants with Ongoing pregnancy

  at 12 weeks' gestation

Study Arms (2)

Vitamin D

EXPERIMENTAL

Participants in the intervention group will be treated with vitamin D 4000IU (800IU per pill, take five pills once each day) per day for around 12 weeks (till the triggering day).

Drug: vitamin D

Placebo

PLACEBO COMPARATOR

Participants in the control group will be treated with equal amount of placebo tablets per day for the same duration.

Other: Placebo

Interventions

vitamin D DRUG

4000IU per day

Also known as: non

Vitamin D

Placebo OTHER

The same doses with vitamin D

Placebo

Eligibility Criteria

• Age: 20 Years - 42 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Women aged 20 to 42 years old;
• Diagnosed with PCOS (Rotterdam Criteria);
• Scheduled for IVF;
• Written informed consent.

You may not qualify if:

• Women who had three or more failed IVF cycles;
• Women scheduled for preimplantation genetic testing;
• Known Vitamin D allergy;
• Women with a history of chronic absorption syndrome or bile dysplasia, or parathyroid dysfunction, or kidney stones, or blood Calcium ion concentration greater than 2.6mmol/L (normal value 2.25 - 2.75mmol/L (9 to 11mg/dl), or hyperphosphataemia (1.61mmol/L), or metabolic-related bone disease, or chronic diseases that may cause bone abnormalities (liver and kidney insufficiency);
• Women receiving treatments for tuberculosis, convulsions, and epilepsy because medications treating these diseases may affect the metabolism of vitamin D.
• Women undergoing an IVF treatment with donor oocytes.

Sponsors & Collaborators

• Women's Hospital School Of Medicine Zhejiang University: lead

Study Sites (2)

Peking University Third Hospital

Beijing, Beijing Municipality, China

Location

Women's Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

Location

Related Publications (1)

• Hu KL, Gan K, Wang R, Li W, Wu Q, Zheng B, Zou L, Zhang S, Liu Y, Wu Y, Chen R, Cao W, Yang S, Liu FT, Tian L, Zeng H, Xu H, Qiu S, Yang L, Chen X, Pan X, Wu X, Mol BW, Li R, Zhang D. Vitamin D supplementation prior to in vitro fertilisation in women with polycystic ovary syndrome: a protocol of a multicentre randomised, double-blind, placebo-controlled clinical trial. BMJ Open. 2020 Dec 8;10(12):e041409. doi: 10.1136/bmjopen-2020-041409.

  PMID: 33293396 DERIVED

MeSH Terms

Conditions

Polycystic Ovary Syndrome

Interventions

Vitamin D

Condition Hierarchy (Ancestors)

Ovarian Cysts; Cysts; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Gonadal Disorders; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Secosteroids; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Dan Zhang, M.D. Ph.D.

  Women's Hospital School Of Medicine Zhejiang University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Participants and most researchers will be unaware of the actual grouping. Only two researchers who are not involved in participant management or data analysis will be aware of the grouping. Vitamin D and placebo pills with identical package, size, colour and appearance will be used in this trial. In general, there should be no need to unblind the allocation. If urgent unbinding to participants is necessary, the allocation will be disclosed to the treating physician.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vice president and Professor

Study Record Dates

• First Submitted: September 4, 2019
• First Posted: September 9, 2019
• Study Start: October 15, 2020
• Primary Completion: May 23, 2024
• Study Completion: January 27, 2025
• Last Updated: January 29, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)