A Phase 1 interventional study of Dydrogesterone Pill in IVF, Oocyte Maturation Defect 1 and Clinical Pregnancy Rate, sponsored by National University of Malaysia. Completed at 1 site in Malaysia. Open to female participants aged 20 Years to 40 Years. Per ClinicalTrials.gov, last updated 2019-11-26.
Sponsored by National University of Malaysia · Phase 1, Interventional, and Other
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.
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.
National University of Malaysia is the lead sponsor of 119 studies on the registry; 42 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Aged 20 - 40 years old
Exclusion Criteria:
low AMH level (AMH less than 3 ng/ml).
Oral Dydrogesterone 10mg tds was given from day 1 of menses till day of trigger
Drug: Dydrogesterone Pill
Oral clomiphene citrate 100mg daily given from day 1 till day 10 of menses with additional gonadotrophin (Menopur 225mg daily) from day 3 of menses till trigger day
started from day 1 of menses till trigger day
Number of oocyte retrieval
number of oocyte retrieved
Time frame: 30 hour after trigger with HCG 10000 International unit (IU)
Biochemical pregnancy rate
serum Bhcg more than 5 mol/L
Time frame: 14 days after embryo transferred
clinical pregnancy rate
presence of intrauterine gestational sac
Time frame: 4 weeks after embryo transfer
Plan to share: No
This study is completed, as verified in Nov 2019. You cannot join it, but the record below documents what was studied.
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National University of Malaysia