Progesterone Supplementation in Frozen Embryo Transfer Cycles

Mount Sinai Hospital, Canada

Status: Unknown

Conditions: Infertility Due to Nonimplantation; Infertility

Treatments: Drug: Prometrium

Study type: Interventional

Funder types: Other

Identifiers

NCT03504345

000

Details and patient eligibility

About

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.

Enrollment: 240 estimated patients

Sex: Female

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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240 participants in 2 patient groups

Control Group

Active Comparator group

Description:

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.

Treatment:

Drug: Prometrium

Experimental Group

Experimental group

Description:

This arm of the study will have their frozen-thawed embryo transfer take place on the seventh day of progesterone supplementation (Prometrium).

Treatment:

Drug: Prometrium