Trial Outcomes & Findings for Embryo Transfer With Self-spent Culture Medium (NCT NCT03728140)

NCT ID: NCT03728140

Last Updated: 2020-01-27

Results Overview

Observe the clinical pregnancy rate under different embryo transfer methods

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 335 participants
• Primary outcome timeframe: 4 weeks
• Results posted on: 2020-01-27

Participant Flow

Participant milestones

Measure	Self-spent Culture Medium 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.	New Culture Medium embryo transfer with new culture medium in IVF-ET
Overall Study STARTED	160	175
Overall Study COMPLETED	150	168
Overall Study NOT COMPLETED	10	7

Reasons for withdrawal

Measure	Self-spent Culture Medium 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.	New Culture Medium embryo transfer with new culture medium in IVF-ET
Overall Study Abnormal embryo transfer operation	10	7

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Self-spent Culture Medium n=150 Participants 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.	New Culture Medium n=168 Participants embryo transfer with new culture medium in IVF-ET	Total n=318 Participants Total of all reporting groups
Age, Continuous	30.31 years STANDARD_DEVIATION 4.08 • n=150 Participants	29.72 years STANDARD_DEVIATION 4.77 • n=168 Participants	29.99 years STANDARD_DEVIATION 4.11 • n=318 Participants
Sex: Female, Male Female	150 Participants n=150 Participants	168 Participants n=168 Participants	318 Participants n=318 Participants
Sex: Female, Male Male	0 Participants n=150 Participants	0 Participants n=168 Participants	0 Participants n=318 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment China	150 Participants n=150 Participants	168 Participants n=168 Participants	318 Participants n=318 Participants
duration of infertility	3.44 years STANDARD_DEVIATION 2.24 • n=150 Participants	3.58 years STANDARD_DEVIATION 3.39 • n=168 Participants	3.51 years STANDARD_DEVIATION 2.97 • n=318 Participants

PRIMARY outcome

Timeframe: 4 weeks

Observe the clinical pregnancy rate under different embryo transfer methods

Outcome measures

Measure	Self-spent Culture Medium n=150 Participants 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.	New Culture Medium n=168 Participants embryo transfer with new culture medium in IVF-ET
Number of Participants Pregnant After 4 Weeks	85 Participants	82 Participants

PRIMARY outcome

Timeframe: 40 weeks

Observe the live birth rate under different embryo transfer methods

Outcome measures

Measure	Self-spent Culture Medium n=150 Participants 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.	New Culture Medium n=168 Participants embryo transfer with new culture medium in IVF-ET
Live Birth	78 Participants	74 Participants

Adverse Events

Self-spent Culture Medium

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

New Culture Medium

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. bin wu

Reproductive medcine of Jinan central hospatil

Phone: +86 053185695203

Email: wb0538@163.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place