NCT05438355

Brief Summary

Polycystic ovarian syndrome (PCOS) is a complex endocrine and metabolic syndrome which accounts for 75% of women with anovulatory infertility. The cause of infertility in PCOS is already unknown. Although efforts have been made, many PCOS patients turned out to have worse oocyte maturity and IVF outcomes. Time-lapse analysis of embryo development can detect the abnormal timeline and cleavage mode which may affect the embryo viability of PCOS. However, there are still some debates on the effect of PCOS on the early embryo development by time-lapse analysis.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
153

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

March 1, 2021

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2021

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2021

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

June 21, 2022

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 29, 2022

Completed
Last Updated

July 6, 2022

Status Verified

July 1, 2022

Enrollment Period

9 months

First QC Date

June 21, 2022

Last Update Submit

July 1, 2022

Conditions

Keywords

PCOSTime-lapseInfertilityMorphokinetics

Outcome Measures

Primary Outcomes (1)

  • Embryonic developmental timing

    Embryonic developmental timing assessed by Time-lapse analysis

    From fertilization until transfer at day 6

Study Arms (2)

The infertility women with PCOS

Infertile women undergoing assisted reproduction were consecutively recruited at Ji Ai G-IVF institute from March 2021 to December 2021. Women aged \< 38 years without endometriosis and more than 6 oocytes were retrieved . Patients were divided in PCOS according to the Rotterdam criteria for PCOS, defined by the presence of anovulation and polycystic ovaries.

The infertility women without PCOS

Infertility women with fallopian tubal factor infertility and with normal menstrual cycles were undergoing IVF/ICSI cycles at Shanghai Ji Ai G-IVF institute from March 2021 to December 2021.Women aged \< 38 years without endometriosis and more than 6 oocytes were retrieved.

Eligibility Criteria

Age20 Years - 37 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Infertility patients udergoing IVF/ICSI cycles at Shanghai JiAi G-IVF institute from March 2021 to December 2021.

You may qualify if:

  • Women aged \< 38 years without endometriosis and with more than 6 oocytes retrieved were eligible.

You may not qualify if:

  • All embryos with more or less than 2 pronuclei, and that did not undergo first cleavage were excluded

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ji Ai Genetics and IVF center

Shanghai, Shanghai Municipality, 200021, China

Location

Related Publications (3)

  • Rotterdam ESHRE/ASRM-Sponsored PCOS Consensus Workshop Group. Revised 2003 consensus on diagnostic criteria and long-term health risks related to polycystic ovary syndrome. Fertil Steril. 2004 Jan;81(1):19-25. doi: 10.1016/j.fertnstert.2003.10.004.

  • Kirkegaard K, Kesmodel US, Hindkjaer JJ, Ingerslev HJ. Time-lapse parameters as predictors of blastocyst development and pregnancy outcome in embryos from good prognosis patients: a prospective cohort study. Hum Reprod. 2013 Oct;28(10):2643-51. doi: 10.1093/humrep/det300. Epub 2013 Jul 30.

  • Gardner DK, Surrey E, Minjarez D, Leitz A, Stevens J, Schoolcraft WB. Single blastocyst transfer: a prospective randomized trial. Fertil Steril. 2004 Mar;81(3):551-5. doi: 10.1016/j.fertnstert.2003.07.023.

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Study Officials

  • Xiaoxi Sun, PHD

    Shanghai G-IVF institute

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 21, 2022

First Posted

June 29, 2022

Study Start

March 1, 2021

Primary Completion

December 1, 2021

Study Completion

December 30, 2021

Last Updated

July 6, 2022

Record last verified: 2022-07

Data Sharing

IPD Sharing
Will not share

Locations