IVF Outcome Following Progestogen Ovarian Stimulation

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

Sponsors

Lead Sponsor: National University of Malaysia

Source National University of Malaysia
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.

Overall Status Completed
Start Date May 10, 2018
Completion Date May 9, 2019
Primary Completion Date March 10, 2019
Phase Phase 1
Study Type Interventional
Primary Outcome
Measure Time Frame
Number of oocyte retrieval 30 hour after trigger with HCG 10000 International unit (IU)
Biochemical pregnancy rate 14 days after embryo transferred
clinical pregnancy rate 4 weeks after embryo transfer
Enrollment 155
Condition
Intervention

Intervention Type: Drug

Intervention Name: Dydrogesterone Pill

Description: started from day 1 of menses till trigger day

Arm Group Label: Progestogen

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.

Gender: Female

Minimum Age: 20 Years

Maximum Age: 40 Years

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Muhammad azrai abu, medical Degree Principal Investigator Department of Obstetrics and Gynecology, UKM Medical Centre
Location
Facility: Medically Assisted Conception Unit, Ukm Medical Centre
Location Countries

Malaysia

Verification Date

November 2019

Responsible Party

Type: Principal Investigator

Investigator Affiliation: National University of Malaysia

Investigator Full Name: Azrai Abu

Investigator Title: Principal Investigator

Keywords
Has Expanded Access No
Number Of Arms 2
Arm Group

Label: Progestogen

Type: Experimental

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

Label: standard combine minimal stimulation protocol

Type: No Intervention

Description: 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

Patient Data No
Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Other

Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Source: ClinicalTrials.gov