Trial Outcomes & Findings for Uterine Contractions and Mode of Progesterone in Frozen Embryo Transfer (FET) Cycles: Randomized Clinical Trial (NCT NCT02078869)

NCT ID: NCT02078869

Last Updated: 2023-04-12

Results Overview

The primary outcome will be the number of contractions per minute assessed over 5 minutes on the day of FET.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 34 participants
• Primary outcome timeframe: on the day of frozen embryo transfer
• Results posted on: 2023-04-12

Participant Flow

Participant milestones

Measure	Intramuscular Progesterone in Oil 50mg of intramuscular Progesterone injection will be administered once daily for 6 days including the day of embryo transfer Progesterone in oil: Daily administration of 50 mg of IM Progesterone	Vaginal Progesterone Suppositories 200mg of progesterone suppositories will be administered 3 times a day for 6 days including the day of embryo transfer vaginal progesterone suppositories: Vaginal Promterium 200 mg , 3 times a day
Overall Study STARTED	17	17
Overall Study COMPLETED	17	17
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Intramuscular Progesterone in Oil n=17 Participants 50mg of intramuscular Progesterone injection will be administered once daily for 6 days including the day of embryo transfer Progesterone in oil: Daily administration of 50 mg of IM Progesterone	Vaginal Progesterone Suppositories n=17 Participants 200mg of progesterone suppositories will be administered 3 times a day for 6 days including the day of embryo transfer vaginal progesterone suppositories: Vaginal Promterium 200 mg , 3 times a day	Total n=34 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=17 Participants	0 Participants n=17 Participants	0 Participants n=34 Participants
Age, Categorical Between 18 and 65 years	17 Participants n=17 Participants	17 Participants n=17 Participants	34 Participants n=34 Participants
Age, Categorical >=65 years	0 Participants n=17 Participants	0 Participants n=17 Participants	0 Participants n=34 Participants
Age, Continuous	35.6 years STANDARD_DEVIATION 3.8 • n=17 Participants	37.1 years STANDARD_DEVIATION 7.1 • n=17 Participants	36.8 years STANDARD_DEVIATION 5.4 • n=34 Participants
Sex: Female, Male Female	17 Participants n=17 Participants	17 Participants n=17 Participants	34 Participants n=34 Participants
Sex: Female, Male Male	0 Participants n=17 Participants	0 Participants n=17 Participants	0 Participants n=34 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment Canada	17 participants n=17 Participants	17 participants n=17 Participants	34 participants n=34 Participants

PRIMARY outcome

Timeframe: on the day of frozen embryo transfer

The primary outcome will be the number of contractions per minute assessed over 5 minutes on the day of FET.

Outcome measures

Measure	Intramuscular Progesterone in Oil n=17 Participants 50mg of intramuscular Progesterone injection will be administered once daily for 6 days including the day of embryo transfer Progesterone in oil: Daily administration of 50 mg of IM Progesterone	Vaginal Progesterone Suppositories n=17 Participants 200mg of progesterone suppositories will be administered 3 times a day for 6 days including the day of embryo transfer vaginal progesterone suppositories: Vaginal Promterium 200 mg , 3 times a day
Number of Uterine Endometrial Contractions Per Minute	2.4 waves per minute Standard Error 4.8	1.4 waves per minute Standard Error 1.1

SECONDARY outcome

Timeframe: The outcome of the study cycle- tested 4 weeks after the transfer

Population: Implantation rate

Four weeks after embryo transfer- routine ultrasound for pregnancy confirmation and number of sacs will be performed and the implantation rate will be calculated as number of sacs divided by number of patients who had embryos transferred

Outcome measures

Measure	Intramuscular Progesterone in Oil n=17 Participants 50mg of intramuscular Progesterone injection will be administered once daily for 6 days including the day of embryo transfer Progesterone in oil: Daily administration of 50 mg of IM Progesterone	Vaginal Progesterone Suppositories n=17 Participants 200mg of progesterone suppositories will be administered 3 times a day for 6 days including the day of embryo transfer vaginal progesterone suppositories: Vaginal Promterium 200 mg , 3 times a day
Implantation Rate	6 Participants	7 Participants

Adverse Events

Intramuscular Progesterone in Oil

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Vaginal Progesterone Suppositories

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

Robert F Casper, PI

TCART

Phone: 416-972-0777

Email: casper@lunenfeld.ca

Results disclosure agreements

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