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NCT04175990

IVF Outcome Following Progestogen Ovarian Stimulation

Completed Phase 1 Last updated 26 November 2019
What this trial tests

Phase 1 trial testing Dydrogesterone Pill in IVF in 155 participants. Completed in 9 May 2019.

Timeline
10 May 2018
Primary endpoint
10 March 2019
9 May 2019

Quick facts

Lead sponsorNational University of Malaysia
PhasePhase 1
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingquadruple
Primary purposeother
Enrollment155
Start date10 May 2018
Primary completion10 March 2019
Estimated completion9 May 2019
Sites1 location across Malaysia

Drugs / interventions tested

Conditions studied

Sponsor

National University of Malaysia

Who can join

Adults 20 to 40, female only, with IVF or Oocyte Maturation Defect 1. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Efficacy of progestin-primed ovarian stimulation in women with polycystic ovary syndrome undergoing <i>in vitro</i> fertilization: a systematic review and meta-analysis.
    Yang L, Liang F, Yuan Y, Luo X, et al · · 2023 · cited 9× · PMID 37795363 · DOI 10.3389/fendo.2023.1224858

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Other trials of Dydrogesterone Pill

Trials testing the same drug.

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Other National University of Malaysia trials

Trials by the same sponsor.

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