ClinicalTrials.gov
ClinicalTrials.gov Menu

Progesterone Supplementation in Frozen Embryo Transfer Cycles

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03504345
Recruitment Status : Not yet recruiting
First Posted : April 20, 2018
Last Update Posted : April 20, 2018
Sponsor:
Information provided by (Responsible Party):
Crystal Chan, 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.


Condition or disease Intervention/treatment Phase
Infertility Due to Nonimplantation Infertility Drug: Prometrium Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 240 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Assessing the Optimal Duration of Progesterone Supplementation Prior to Transfer of Frozen Embryos in the Recurrent Implantation Failure Population
Estimated Study Start Date : May 2018
Estimated Primary Completion Date : April 2019
Estimated Study Completion Date : July 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Control Group
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
The intervention will involve delaying the transfer of a frozen-thawed embryo into the uterus to increase the duration of progesterone exposure.

Experimental: Experimental Group
This arm of the study will have their frozen-thawed embryo transfer take place on the seventh day of progesterone supplementation (Prometrium).
Drug: Prometrium
The intervention will involve delaying the transfer of a frozen-thawed embryo into the uterus to increase the duration of progesterone exposure.




Primary Outcome Measures :
  1. clinical pregnancy rate [ Time Frame: 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 :
  1. Live birth rate [ Time Frame: 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

  2. Miscarriage rate [ Time Frame: 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03504345


Contacts
Contact: Crystal Chan, MD, MSc, FRCSC 416-586-4800 ext 6024 crystal.chan@sinaihealthsystem.ca

Sponsors and Collaborators
Mount Sinai Hospital, Canada

Responsible Party: Crystal Chan, Clinician Investigator, Assistant Professor, Department of Obstetrics & Gynaecology, Mount Sinai Hospital, Canada
ClinicalTrials.gov Identifier: NCT03504345     History of Changes
Other Study ID Numbers: 000
First Posted: April 20, 2018    Key Record Dates
Last Update Posted: April 20, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Infertility
Genital Diseases, Male
Genital Diseases, Female
Progesterone
Progestins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs