Clinical trial NCT04175990: IVF Outcome Following Progestogen Ovarian Stimulation
Official title: Role Of Dydrogesterone Towards Oocyte and Embryo Quality in Polycystic Ovarian Syndrome (PCOS)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: IVF
Oocyte Maturation Defect 1
Clinical Pregnancy Rate
Ovarian Hyperstimulation
Keywords: progestogen
ovarian stimulation regime
IVF outcome
Lead sponsor: National University of Malaysia
Sponsor class: OTHER
First posted: 2019-11-25
Enrollment: 155
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* · Aged 20 - 40 years old

  * Basal serum follicular stimulating hormone(FSH) level of no more than 10 IU/L
  * Diagnosis of PCOS met using Rotterdam criteria.

Exclusion Criteria:

* low AMH level (AMH less than 3 ng/ml).

  * Contraindicated to ovarian stimulation treatment eg: history of severe ovarian hyper stimulation syndrome(OHSS)
  * Presence of uterine pathology eg: adenomyosis, large uterine fibroid.
  * Patients who has had poor ovarian stimulation of twice or more.

Primary outcomes:
measure: Number of oocyte retrieval
timeFrame: 30 hour after trigger with HCG 10000 International unit (IU)
measure: Biochemical pregnancy rate
timeFrame: 14 days after embryo transferred
measure: clinical pregnancy rate
timeFrame: 4 weeks after embryo transfer
Secondary outcomes:
Other outcomes:
Locations:
city: Cheras
country: Malaysia
facility: Medically Assisted Conception Unit, Ukm Medical Centre
state: Kuala Lumpur
Study officials:
affiliation: Department of Obstetrics and Gynecology, UKM Medical Centre
name: Muhammad azrai abu, medical Degree
role: PRINCIPAL_INVESTIGATOR
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