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Completed

NCT Number: NCT04175990

IVF Outcome Following Progestogen Ovarian Stimulation

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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Key information

Age range

20 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1

Primary location

Medically Assisted Conception Unit, Ukm Medical Centre

Cheras, Kuala Lumpur, 56000, Malaysia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Dydrogesterone Pill

Drug

started from day 1 of menses till trigger day

Primary outcomes

  1. Number of oocyte retrieval

    Time frame: 30 hour after trigger with HCG 10000 International unit (IU)

    number of oocyte retrieved

  2. Biochemical pregnancy rate

    Time frame: 14 days after embryo transferred

    serum Bhcg more than 5 mol/L

  3. clinical pregnancy rate

    Time frame: 4 weeks after embryo transfer

    presence of intrauterine gestational sac

Sponsors and collaborators

Lead sponsor

National University of Malaysia

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Nov 25, 2019
Registry last updated
Nov 26, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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