IVF Outcome Following Progestogen Ovarian Stimulation

Phase 1

Completed

• Conditions: Clinical Pregnancy Rate; Oocyte Maturation Defect 1; Ovarian Hyperstimulation; IVF
• Interventions: Drug: Dydrogesterone Pill

• Registration Number: NCT04175990
• Lead Sponsor: 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.

Study Timeline

• Study Start: 2018-05-10
• Primary Completion: 2019-03-10
• Study Completion: 2019-05-09
• Status Verified: 2019-11
• Study First Submitted: 2019-11-20
• Study First Submitted QC: 2019-11-21
• Last Update Submitted: 2019-11-22
• Study First Posted: 2019-11-25
• Last Update Posted: 2019-11-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 155

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Progestogen	Dydrogesterone Pill	Oral Dydrogesterone 10mg tds was given from day 1 of menses till day of trigger

Primary Outcome Measures

Name	Time	Method
Biochemical pregnancy rate	14 days after embryo transferred	serum Bhcg more than 5 mol/L
Number of oocyte retrieval	30 hour after trigger with HCG 10000 International unit (IU)	number of oocyte retrieved
clinical pregnancy rate	4 weeks after embryo transfer	presence of intrauterine gestational sac

Trial Locations

Locations (1)

Medically Assisted Conception Unit, Ukm Medical Centre; 🇲🇾 Cheras, Kuala Lumpur, Malaysia