Embryo Transfer With Self-spent Culture Medium

• Sponsor: Bin Wu (Other)
• Overall Status: Completed
• CT.gov ID: NCT03728140
• Collaborator: (none)
• Enrollment: 335
• Location: 1
• Arms: 2
• Actual Duration (Months): 24
• Patients Per Site Per Month: 14

Study Details

Study Description

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?

Condition or Disease	Intervention/Treatment	Phase
in Vitro Fertilization	Procedure: Self-spent Culture Medium	N/A

Detailed Description

Although some metabolites are present in self-spent culture medium, there are some embryonic exocrine factors secreted by embryo.These factors may have a positive impact on embryo implantation and subsequent development. So it is necessary to compare the two ways of embryo transfer with Self-spent Culture Medium or New Culture Medium in vitro fertilization - embryo transfer process.

The purpose of this study is to analyze which way can improve clinical pregnancy and birth outcomes, is there a significant difference between the two?

Study Design

• Study Type: Interventional
• Actual Enrollment: 335 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Screening
• Official Title: Can Embryo Transfer With Self-spent Culture Medium Improve Clinical Pregnancy Outcomes in Vitro Fertilization - Embryo Transfer Process?
• Actual Study Start Date: Jan 1, 2018
• Actual Primary Completion Date: Dec 31, 2019
• Actual Study Completion Date: Dec 31, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Self-spent Culture Medium Changing embryo transfer solution with self-spent culture medium	Procedure: Self-spent Culture Medium; Replace embryo transfer solution with Self-spent culture medium in IVF-ET.
No Intervention: New Culture Medium embryo transfer with new culture medium in IVF-ET

Outcome Measures

Primary Outcome Measures

1. Number of Participants Pregnant After 4 Weeks [4 weeks]

   Observe the clinical pregnancy rate under different embryo transfer methods

2. Live Birth [40 weeks]

   Observe the live birth rate under different embryo transfer methods

Eligibility Criteria

Criteria

• Ages Eligible for Study: 25 Years to 35 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Infertility female patients with tubal factors,

• Infertile female patients with spouse factors

Exclusion Criteria:

• Intrauterine adhesions,

• Endometriosis,

• Primary ovarian insufficiency，

• Infectious disease

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Jinan Central Hospital Affiliated to Shandong University	Jinan	Shandong	China	250013

Sponsors and Collaborators

• Bin Wu

Investigators

• Study Director: Yingchun zhang, Dr, Jinan Central Hospital

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Dec 1, 2019

More Information

Publications

None provided.

• Responsible Party: Bin Wu, Reproductive medcine, Jinan Central Hospital
• ClinicalTrials.gov Identifier: NCT03728140
• Other Study ID Numbers: JianCH-RM001
• First Posted: Nov 1, 2018
• Last Update Posted: Jan 27, 2020
• Last Verified: Dec 1, 2019

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Bin Wu, Reproductive medcine, Jinan Central Hospital: Embryo Transfer

Study Results

Participant Flow

Arm/Group Title	Self-spent Culture Medium	New Culture Medium
Arm/Group Description	Changing embryo transfer solution with self-spent culture medium Self-spent Culture Medium: Replace embryo transfer solution with Self-spent culture medium in IVF-ET.	embryo transfer with new culture medium in IVF-ET
Period Title: Overall Study
STARTED	160	175
COMPLETED	150	168
NOT COMPLETED	10	7

Baseline Characteristics

Arm/Group Title	Self-spent Culture Medium	New Culture Medium	Total
Arm/Group Description	Changing embryo transfer solution with self-spent culture medium Self-spent Culture Medium: Replace embryo transfer solution with Self-spent culture medium in IVF-ET.	embryo transfer with new culture medium in IVF-ET	Total of all reporting groups
Overall Participants	150	168	318
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	30.31 (4.08)	29.72 (4.77)	29.99 (4.11)
Sex: Female, Male (Count of Participants)
Female	150 100%	168 100%	318 100%
Male	0 0%	0 0%	0 0%
Race and Ethnicity Not Collected (Count of Participants)
Count of Participants [Participants]	0 0%
Region of Enrollment (Count of Participants)
China	150 100%	168 100%	318 100%
duration of infertility (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	3.44 (2.24)	3.58 (3.39)	3.51 (2.97)

Outcome Measures

1. Primary Outcome

Title	Number of Participants Pregnant After 4 Weeks
Description	Observe the clinical pregnancy rate under different embryo transfer methods
Time Frame	4 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Self-spent Culture Medium	New Culture Medium
Arm/Group Description	Changing embryo transfer solution with self-spent culture medium Self-spent Culture Medium: Replace embryo transfer solution with Self-spent culture medium in IVF-ET.	embryo transfer with new culture medium in IVF-ET
Measure Participants	150	168
Count of Participants [Participants]	85 56.7%	82 48.8%

2. Primary Outcome

Title	Live Birth
Description	Observe the live birth rate under different embryo transfer methods
Time Frame	40 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Self-spent Culture Medium	New Culture Medium
Arm/Group Description	Changing embryo transfer solution with self-spent culture medium Self-spent Culture Medium: Replace embryo transfer solution with Self-spent culture medium in IVF-ET.	embryo transfer with new culture medium in IVF-ET
Measure Participants	150	168
Count of Participants [Participants]	78 52%	74 44%

Adverse Events

Time Frame	1 year
Adverse Event Reporting Description	No any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research,
Arm/Group Title	Self-spent Culture Medium		New Culture Medium
Arm/Group Description	embryo transfer with self-spent culture medium		embryo transfer with new culture medium
All Cause Mortality
	Self-spent Culture Medium		New Culture Medium
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/150 (0%)		0/168 (0%)
Serious Adverse Events
	Self-spent Culture Medium		New Culture Medium
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/150 (0%)		0/168 (0%)
Other (Not Including Serious) Adverse Events
	Self-spent Culture Medium		New Culture Medium
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/150 (0%)		0/168 (0%)

Limitations/Caveats

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

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.