Progesterone Supplementation in Frozen Embryo Transfer Cycles

Infertility Clinical Trial

Official title:

Assessing the Optimal Duration of Progesterone Supplementation Prior to Transfer of Frozen Embryos in the Recurrent Implantation Failure Population

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03504345
• Other study ID #: 000
• Status: Not yet recruiting
• Phase: N/A
• First received: April 12, 2018
• Last updated: April 12, 2018
• Start date: May 2018
• Est. completion date: July 2019

Study information

• Verified date: April 2018
• Source: Mount Sinai Hospital, Canada
• Contact: Crystal Chan, MD, MSc, FRCSC
• Phone: 416-586-4800
• Email: crystal.chan[@]sinaihealthsystem.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Recurrent implantation failure (RIF) occurs after women undergo in vitro fertilization and have multiple embryos transferred but no resulting pregnancies. RIF is a very challenging clinical entity for the reproductive physician and the patient. In fact, there is not even an agreed upon definition in the medical community. Many potential causes have been investigated over the past several years but no clear answer has emerged. Interest has recently turned to the endometrium, or the lining of the uterus. Studies have shown that the genes that are turned on in the endometrium vary based on how long this tissue has been exposed to progesterone, an important hormone that prepares the uterine lining for implantation of the growing embryo. In some women, it seems that they require longer periods of progesterone exposure to reach the same state of readiness. We hypothesize that an even larger proportion of women in RIF population will require longer treatments with progesterone.

In this study, we will randomize women with RIF who are about to undergo a frozen embryo transfer to one of two groups. The first group will have their embryo transfer done on the standard sixth day of progesterone treatment. The other group will have their transfer done on the seventh day of progesterone. We will be comparing the clinical pregnancy rate of the two groups as well as the live birth rate and miscarriage rate. We expect that extending the progesterone treatment by one day will increase the pregnancy rate of women with RIF.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 240
• Est. completion date: July 2019
• Est. primary completion date: April 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

• Patient at Mount Sinai Fertility who wants to undertake a frozen embryo transfer

• History of recurrent implantation failure, defined as no pregnancy after three or more embryo transfers of four or more good quality blastocysts

Exclusion Criteria:

• Previous testing with Endometrial Receptivity Assay (ERA)

• Unable understand/communicate in English

Related Conditions & MeSH terms

• Infertility
• Infertility Due to Nonimplantation

Intervention

Drug:
• Prometrium
The intervention will involve delaying the transfer of a frozen-thawed embryo into the uterus to increase the duration of progesterone exposure.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Mount Sinai Hospital, Canada

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	clinical pregnancy rate	Rate of pregnancy, evidenced by clinical (fetal heartbeat) or ultrasound parameters (ultrasound visualization of a gestational sac, embryonic pole with heartbeat). It includes ectopic pregnancy.	6 to 8 weeks after embryo transfer
Secondary	Live birth rate	Rate of birth in which a fetus is delivered with signs of life after complete expulsion or extraction from its mother, beyond 20 completed weeks of gestational age	Approximately 9 months after embryo transfer
Secondary	Miscarriage rate	Rate of natural death of embryo or fetus, after reaching clinical pregnancy stage and at or before 10 weeks gestation.	Approximately 3 months after embryo transfer