Medically Assisted Conception Unit, Ukm Medical Centre
Cheras, Kuala Lumpur, 56000, Malaysia
NCT Number: NCT04175990
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.
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Notify Me20 year–40 year
Female
Interventional
Phase 1
Cheras, Kuala Lumpur, 56000, Malaysia
This is a prospective controlled cohort study conducted at the Department of Medical Assisted Conception (MAC) unit of the University Kebangsaan Malaysia Medical Centre (UKMMC). From May 2018 through May 2019, women with Polycystic Ovarian Syndrome (PCOS) undergoing IVF/intracytoplasmic sperm insemination(ICSI) regimens for the treatment of infertility were recruited.
Patients recruited will then be randomized accordingly using the randomizer software. Group A will be the interventional group and group B will be the control group.
Oocyte retrieval will be performed 34-36 hours following the human chorionic gonadotrophin (hCG) trigger. Sperm was obtained on the same day. Mature oocytes will be fertilized with sperm via IVF or ICSI. Fertilized embryos were observed via time laps method and the progress and cleavage were monitored before planning for embryo transfer. Embryo transfer will be performed on day 3 or day 5 after oocyte retrieval.
All results will be analyzed using Statistical Package for the Social Sciences(SPSS) version 21 software. Descriptive analysis will be done for demographic data and presented in mean ± Standard deviation (SD). Demographic characteristic between the two groups will be compared with the use of the Mann-Whitney U test. The categorical data was analysed by using Chi-square test for the association of variables. A p-value of 0.05 or less was considered to be significant.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
started from day 1 of menses till trigger day
Time frame: 30 hour after trigger with HCG 10000 International unit (IU)
number of oocyte retrieved
Time frame: 14 days after embryo transferred
serum Bhcg more than 5 mol/L
Time frame: 4 weeks after embryo transfer
presence of intrauterine gestational sac
National University of Malaysia
Other
Role Of Dydrogesterone Towards Oocyte and Embryo Quality in Polycystic Ovarian Syndrome (PCOS)
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