CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 155 enrolled
Drug / intervention
Dydrogesterone Pilldrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04175990
NCT04175990Phase 1Completed

Role Of Dydrogesterone Towards Oocyte and Embryo Quality in Polycystic Ovarian Syndrome (PCOS)

National University of Malaysia·interventional·Posted Nov 25, 2019·Updated Nov 26, 2019

In Brief

A Phase 1 clinical trial evaluating Dydrogesterone Pill for IVF and 3 related conditions. Completed, enrolled 155 participants across 1 site.

Detailed Summary

The new strategy is by using the progestogen to block the luteinizing hormone(LH) surge either endogenous during luteal phase stimulation, or exogenous in the follicular phase i.e progestin primed ovarian stimulation (PPOS). The goal of PPOS is to develop a single dominant follicle. Various types of oral Progestin had been studied before including Medroxyprogesterone Acetate (MPA) and Utrogestan with different dosage. A different study by Wang et al conducted by using MPA to patients with PCOS. The use of MPA is contraindicated in human pregnancy whereas Dydrogesterone had been extensively used worldwide for the treatment of threatened miscarriage as well as luteal support in infertility setting. Previous protocol on PPOS showed inconclusive results. Therefore in this study, Dydrogesterone was used as the Progestin Primed Ovarian hyperstimulation to explore its effect on PCOS women IVF outcome.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesMalaysia
Collaborators--

Timeline

Phase 1CompletedFinished
20192020202120222023202420252026
First PostedNov 25, 2019
Enrollment StartMay 10, 2018
Primary CompletionMar 10, 2019
Study CompletionMay 9, 2019
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 6.6 years ago

Interventions

Dydrogesterone Pilldrug

started from day 1 of menses till trigger day