NCT03134482

Brief Summary

Polycystic ovarian syndrome (PCOS) is most common endocrinologic disease in women of reproductive age with incidence of 6.6 \~ 8%. About fifty percent of the patients with PCOS manifest subfertility and significant proportion of these woman need assisted reproductive technology (ART). These patients are very sensitive to gonadotropins during conventional in vitro fertilization (IVF) and the risk of ovarian hyperstimulation syndrome (OHSS) is high. In vitro maturation (IVM) is an emerging alternative option to conventional IVF for minimizing the risk of OHSS in patients with PCOS. Until now, several studies has been reported the favorable outcomes of oocyte maturation rate, fertilization rate, clinical pregnancy rate, and live birth rate during IVM procedure. However, these results were from retrospective or observational study and there was no suitable randomized controlled trial (RCT). Therefore, this prospective RCT is aimed to compare and analyze the clinical outcomes between IVM and minimal stimulation IVF in women with PCOS, assessing if IVM is recommendable clinical practice or not.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
240

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 11, 2017

Completed
20 days until next milestone

First Posted

Study publicly available on registry

May 1, 2017

Completed
Same day until next milestone

Study Start

First participant enrolled

May 1, 2017

Completed
5.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

March 24, 2020

Status Verified

March 1, 2020

Enrollment Period

5.7 years

First QC Date

April 11, 2017

Last Update Submit

March 23, 2020

Conditions

No Condition

Keywords

in vitro maturation (IVM)polycystic ovarian syndrome (PCOS)ovarian hyperstimulation syndrome (OHSS)assisted reproductive technology (ART)

Outcome Measures

Primary Outcomes (1)

  • Clinical pregnancy rate

    Clinical pregnancy was determined by observation of a gestational sac with fetal heart beat by transvaginal ultrasound scan.

    At 6 weeks of pregnancy

Secondary Outcomes (1)

  • Incidence rate of Ovarian hyperstimulation syndrome (OHSS)

    Until three weeks later after hCG injection

Study Arms (2)

In vitro maturation (IVM)

EXPERIMENTAL

hCG primed in vitro maturation (IVM) procedure Gonadotropin is not used in this patient group If the endometrial thickness in 6mm or more and the mean diameter of largest follicle is 11 mm or less on menstrual cycle day 9 to 12 on ultrasonography, oocyte retrieval is planned two days later. Recombinant hCG injection (priming) is given 36 hour before oocyte retrieval, followed by intracytoplasmic sperm injection (ICSI) for oocyte fertilization. The biochemical pregnancy is confirmed by serum beta hCG 15 days later oocyte retrieval. The clinical pregnancy is confirmed when gestational sac is detected by transvaginal ultrasonography 3 weeks later oocyte retrieval.

Procedure: IVM

Minimal stimulation IVF

ACTIVE COMPARATOR

minimal stimulation IVF procedure These patients are stimulated with 150 or less IU of recombinant Follicle-stimulating hormone (FSH) from menstrual cycle day 3 in GnRH antagonist protocol. If the mean diameters of two or more follicles are 17mm or more, oocyte retrieval is planned two days later. Recombinant hCG is triggered 36 hour before oocyte retrieval, followed by intracytoplasmic sperm injection (ICSI) for oocyte fertilization if needed. The biochemical pregnancy is confirmed by serum beta hCG 14 days later oocyte retrieval. The clinical pregnancy is confirmed when gestational sac is detected by transvaginal ultrasonography 3 weeks later oocyte retrieval.

Procedure: Minimal stimulation IVF

Interventions

IVMPROCEDURE

No gonadotropin is used, but hCG priming is utilized 36 hour before oocyte maturation.

In vitro maturation (IVM)
Minimal stimulation IVFPROCEDURE

IVF with minimal use of gonadotropin, i.e. 150 or less IU of recombinant FSH, followed by hCG triggering in GnRH antagonist protocol.

Minimal stimulation IVF

Eligibility Criteria

Age20 Years - 39 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Women diagnosed with PCOS under age of 40 years (PCOS diagnosis is based on Revised 2003 Rotterdam criteria of PCOS)

You may not qualify if:

  • severe male factor subfertility requiring testicular sperm extraction (TESE) or oligoasthenoteratozoospermia
  • couples requiring preimplantation genetic screening or diagnosis
  • women had undergone ovarian stimulation 30 days before assisted reproductive technology (ART)
  • women with severe endometriosis or dysfunctional uterine bleeding
  • women with severe uterine factor subfertility (ex. submucosal myoma, intramural myoma protruding endometrium, severe intrauterine adhesion, etc)
  • women with ovarian malignancy
  • women with severe tubal factor subfertility (ex. persistent hydrosalpinx even after surgery)
  • women had undergone treatment of malignancy 5 years before screening of this trial
  • women with history of thromboembolism
  • women with age of 40 years or more
  • women with stimulation dose over 150 IU of exogenous FSH

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

CHA Fertility Center, Seoul station

Seoul, 04367, South Korea

RECRUITING

CHA Gangnam medical center

Seoul, 06135, South Korea

RECRUITING

Related Publications (9)

  • Siristatidis CS, Vrachnis N, Creatsa M, Maheshwari A, Bhattacharya S. In vitro maturation in subfertile women with polycystic ovarian syndrome undergoing assisted reproduction. Cochrane Database Syst Rev. 2013 Oct 8;(10):CD006606. doi: 10.1002/14651858.CD006606.pub3.

    PMID: 24101529BACKGROUND

  • Cha KY, Chung HM, Lee DR, Kwon H, Chung MK, Park LS, Choi DH, Yoon TK. Obstetric outcome of patients with polycystic ovary syndrome treated by in vitro maturation and in vitro fertilization-embryo transfer. Fertil Steril. 2005 May;83(5):1461-5. doi: 10.1016/j.fertnstert.2004.11.044.

    PMID: 15866585BACKGROUND

  • Choi MH, Lee SH, Kim HO, Cha SH, Kim JY, Yang KM, Song IO, Koong MK, Kang IS, Park CW. Comparison of assisted reproductive technology outcomes in infertile women with polycystic ovary syndrome: In vitro maturation, GnRH agonist, and GnRH antagonist cycles. Clin Exp Reprod Med. 2012 Dec;39(4):166-71. doi: 10.5653/cerm.2012.39.4.166. Epub 2012 Dec 31.

    PMID: 23346527BACKGROUND

  • Child TJ, Phillips SJ, Abdul-Jalil AK, Gulekli B, Tan SL. A comparison of in vitro maturation and in vitro fertilization for women with polycystic ovaries. Obstet Gynecol. 2002 Oct;100(4):665-70. doi: 10.1016/s0029-7844(02)02193-2.

    PMID: 12383531BACKGROUND

  • Chian RC, Buckett WM, Tulandi T, Tan SL. Prospective randomized study of human chorionic gonadotrophin priming before immature oocyte retrieval from unstimulated women with polycystic ovarian syndrome. Hum Reprod. 2000 Jan;15(1):165-70. doi: 10.1093/humrep/15.1.165.

    PMID: 10611207BACKGROUND

  • Soderstrom-Anttila V, Makinen S, Tuuri T, Suikkari AM. Favourable pregnancy results with insemination of in vitro matured oocytes from unstimulated patients. Hum Reprod. 2005 Jun;20(6):1534-40. doi: 10.1093/humrep/deh768. Epub 2005 Feb 3.

    PMID: 15695312BACKGROUND

  • Reavey J, Vincent K, Child T, Granne IE. Human chorionic gonadotrophin priming for fertility treatment with in vitro maturation. Cochrane Database Syst Rev. 2016 Nov 16;11(11):CD008720. doi: 10.1002/14651858.CD008720.pub2.

    PMID: 27852101BACKGROUND

  • Aboulghar MA, Mansour RT. Ovarian hyperstimulation syndrome: classifications and critical analysis of preventive measures. Hum Reprod Update. 2003 May-Jun;9(3):275-89. doi: 10.1093/humupd/dmg018.

    PMID: 12859048BACKGROUND

  • Siristatidis CS, Papapanou M, Maheshwari A, Vaidakis D. In vitro maturation in subfertile women with polycystic ovarian syndrome undergoing assisted reproduction. Cochrane Database Syst Rev. 2025 Feb 6;2(2):CD006606. doi: 10.1002/14651858.CD006606.pub5.

    PMID: 39912435DERIVED

MeSH Terms

Conditions

Polycystic Ovary SyndromeOvarian Hyperstimulation Syndrome

Condition Hierarchy (Ancestors)

Ovarian CystsCystsNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesGonadal DisordersEndocrine System Diseases

Study Officials

  • You Shin Kim, MD, PhD

    Fertility center of CHA Gangnam medical center, CHA university

    PRINCIPAL INVESTIGATOR

Central Study Contacts

You Shin Kim, MD, PhD

CONTACT

82-2-2002-0303medikys@cha.ac.kr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

April 11, 2017

First Posted

May 1, 2017

Study Start

May 1, 2017

Primary Completion

December 31, 2022

Study Completion

December 31, 2023

Last Updated

March 24, 2020

Record last verified: 2020-03

Data Sharing

IPD Sharing
Will not share

Locations

KR(2)