NCT03728140

Brief Summary

Embryo Transfer With Self-spent Culture Medium or new Culture Medium in Vitro Fertilization - Embryo Transfer Process, to analyze which way can improve clinical pregnancy outcomes, is there a significant difference between the two?

Trial Health

87
On Track

Trial Health Score

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

Enrollment
335

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2018

Typical duration for not_applicable

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

January 1, 2018

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

October 29, 2018

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 1, 2018

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2019

Completed
27 days until next milestone

Results Posted

Study results publicly available

January 27, 2020

Completed
Last Updated

January 27, 2020

Status Verified

December 1, 2019

Enrollment Period

2 years

First QC Date

October 29, 2018

Results QC Date

December 31, 2019

Last Update Submit

January 14, 2020

Conditions

in Vitro Fertilization

Keywords

Embryo Transfer

Outcome Measures

Primary Outcomes (2)

  • Number of Participants Pregnant After 4 Weeks

    Observe the clinical pregnancy rate under different embryo transfer methods

    4 weeks

  • Live Birth

    Observe the live birth rate under different embryo transfer methods

    40 weeks

Study Arms (2)

Self-spent Culture Medium

EXPERIMENTAL

Changing embryo transfer solution with self-spent culture medium

Procedure: Self-spent Culture Medium

New Culture Medium

NO INTERVENTION

embryo transfer with new culture medium in IVF-ET

Interventions

Self-spent Culture MediumPROCEDURE

Replace embryo transfer solution with Self-spent culture medium in IVF-ET.

Self-spent Culture Medium

Eligibility Criteria

Age25 Years - 35 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsWomen in childbearing age intend to do IVF
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Infertility female patients with tubal factors,
  • Infertile female patients with spouse factors

You may not qualify if:

  • Intrauterine adhesions,
  • Endometriosis,
  • Primary ovarian insufficiency，
  • Infectious disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jinan Central Hospital Affiliated to Shandong University

Jinan, Shandong, 250013, China

Location

Limitations and Caveats

Studies of larger sample sizes and studies on some other variables were needed to be further performed.

Results Point of Contact

Title
Dr. bin wu
Organization
Reproductive medcine of Jinan central hospatil
wb0538@163.com
+86 053185695203

Study Officials

  • Yingchun zhang, Dr

    Jinan Central Hospital

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Reproductive medcine

Study Record Dates

First Submitted

October 29, 2018

First Posted

November 1, 2018

Study Start

January 1, 2018

Primary Completion

December 31, 2019

Study Completion

December 31, 2019

Last Updated

January 27, 2020

Results First Posted

January 27, 2020

Record last verified: 2019-12

Locations

CN(1)