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IVF Outcome Following Progestogen Ovarian Stimulation

Sponsor
National University of Malaysia (Other)
Overall Status
Completed
CT.gov ID
NCT04175990
Collaborator
(none)
155
Enrollment
1
Location
2
Arms
12
Actual Duration (Months)
13
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Dydrogesterone Pill
 Phase 1

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
155 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Other
Official Title:
Role Of Dydrogesterone Towards Oocyte and Embryo Quality in Polycystic Ovarian Syndrome (PCOS)
Actual Study Start Date :
May 10, 2018
Actual Primary Completion Date :
Mar 10, 2019
Actual Study Completion Date :
May 9, 2019

Arms and Interventions

Arm Intervention/Treatment
Experimental: Progestogen

Oral Dydrogesterone 10mg tds was given from day 1 of menses till day of trigger

Drug: Dydrogesterone Pill
started from day 1 of menses till trigger day
No Intervention: standard combine minimal stimulation protocol

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

Outcome Measures

Primary Outcome Measures

  1. Number of oocyte retrieval [30 hour after trigger with HCG 10000 International unit (IU)]

    number of oocyte retrieved

  2. Biochemical pregnancy rate [14 days after embryo transferred]

    serum Bhcg more than 5 mol/L

  3. clinical pregnancy rate [4 weeks after embryo transfer]

    presence of intrauterine gestational sac

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years to 40 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Medically Assisted Conception Unit, Ukm Medical Centre Cheras Kuala Lumpur Malaysia 56000

Sponsors and Collaborators

  • National University of Malaysia

Investigators

  • Principal Investigator: Muhammad azrai abu, medical Degree, Department of Obstetrics and Gynecology, UKM Medical Centre

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Azrai Abu, Principal Investigator, National University of Malaysia
ClinicalTrials.gov Identifier:
NCT04175990
Other Study ID Numbers:
  • UKMPPI/111/8/JEP-2018-165
First Posted:
Nov 25, 2019
Last Update Posted:
Nov 26, 2019
Last Verified:
Nov 1, 2019
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Product Manufactured in and Exported from the U.S.:
No
Keywords provided by Azrai Abu, Principal Investigator, National University of Malaysia
progestogen
ovarian stimulation regime
IVF outcome
Additional relevant MeSH terms:
Dydrogesterone

Study Results

No Results Posted as of Nov 26, 2019