Progesterone Supplementation in Frozen Embryo Transfer Cycles

NCT03504345 | Unknown

• 1 other identifier: 000
• Study Type: interventional
• Target: 240
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Infertility Due to Nonimplantation; Infertility

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Live birth rate

  Approximately 9 months after embryo transfer

• Miscarriage rate

  Approximately 3 months after embryo transfer

Study Arms (2)

Control Group

ACTIVE COMPARATOR

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.

Drug: Prometrium

Experimental Group

EXPERIMENTAL

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

Drug: Prometrium

Interventions

Prometrium DRUG

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

Control Group; Experimental Group

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• Previous testing with Endometrial Receptivity Assay (ERA)
• Unable understand/communicate in English

Sponsors & Collaborators

• Mount Sinai Hospital, Canada: lead

MeSH Terms

Conditions

Infertility

Interventions

Progesterone

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Pregnenediones; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Corpus Luteum Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Progesterone Congeners; Gonadal Steroid Hormones

Central Study Contacts

Crystal Chan, MD, MSc, FRCSC

CONTACT

416-586-4800; crystal.chan@sinaihealthsystem.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinician Investigator, Assistant Professor, Department of Obstetrics & Gynaecology

Study Record Dates

• First Submitted: April 12, 2018
• First Posted: April 20, 2018
• Study Start: May 1, 2018
• Primary Completion: April 1, 2019
• Study Completion: July 1, 2019
• Last Updated: April 20, 2018

Record last verified: 2018-04

Data Sharing

• IPD Sharing: Will not share