Progesterone Supplementation in Frozen Embryo Transfer Cycles

Not Applicable

• Conditions: Infertility; Infertility Due to Nonimplantation
• Interventions: Drug: Prometrium

• Registration Number: NCT03504345
• Lead Sponsor: Mount Sinai Hospital, Canada

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2018-04
• Study First Submitted: 2018-04-12
• Study First Submitted QC: 2018-04-12
• Last Update Submitted: 2018-04-12
• Study First Posted: 2018-04-20
• Last Update Posted: 2018-04-20
• Study Start: 2018-05
• Primary Completion: 2019-04
• Study Completion: 2019-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 240

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control Group	Prometrium	This arm of the study will have their frozen-thawed embryo transfer take place on the sixth day of progesterone supplementation (Prometrium), which is the standard protocol in our clinic.
Experimental Group	Prometrium	This arm of the study will have their frozen-thawed embryo transfer take place on the seventh day of progesterone supplementation (Prometrium).

Primary Outcome Measures

Name	Time	Method
clinical pregnancy rate	6 to 8 weeks after embryo transfer	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.

Secondary Outcome Measures

Name	Time	Method
Live birth rate	Approximately 9 months after embryo transfer	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
Miscarriage rate	Approximately 3 months after embryo transfer	Rate of natural death of embryo or fetus, after reaching clinical pregnancy stage and at or before 10 weeks gestation.