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Natural Cycle/Progesterone Fortified Protocol for Endometrial Preparation for Frozen/Thawed Embryo Transfer

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ClinicalTrials.gov Identifier: NCT02749344
Recruitment Status : Recruiting
First Posted : April 22, 2016
Last Update Posted : August 17, 2018
Sponsor:
Information provided by (Responsible Party):
Amir Weiss, HaEmek Medical Center, Israel

Brief Summary:
This is a pilot study of a novel protocol for preparation of the endometrium for frozen/thawed embryo transfer whereby estrogen is not administered during the proliferative phase and progesterone is administered through vaginal suppositories in accordance with endometrial thickness only, disregarding the day of ovulation. Progesterone supplementation commences once the endometrium is at least 7 mm, a follicle is demonstrated on TVS, and ovulation has not yet taken place. The day of ET is scheduled according to the unit's working days and progesterone suppositories are commenced 48 hours before the scheduled embryo transfer.

Condition or disease Intervention/treatment Phase
Infertility Other: FET after endometrial preparation Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Natural Cycle/Progesterone Fortified Protocol for Endometrial Preparation for Frozen/Thawed Embryo Transfer
Actual Study Start Date : May 2016
Estimated Primary Completion Date : April 2019
Estimated Study Completion Date : April 1, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: FET after endometrial preparation
Natural cycle/progesterone fortified endometrial preparation before embryo transfer
Other: FET after endometrial preparation
Patients included in the protocol will begin progesterone supplementation 48 hours before scheduled embryo transfer once it has been established that the endometrium is at least 7 mm and there is a leading follicle.




Primary Outcome Measures :
  1. Biochemical Pregnancy [ Time Frame: 14 days after embryo transfer ]
    Positive betaHCG blood test


Secondary Outcome Measures :
  1. Clinical Pregnancy [ Time Frame: 3-4 weeks after embryo transfer ]
    Ultrasound detection of intrauterine gestational sac

  2. Ongoing Pregnancy [ Time Frame: 5 weeks after embryo transfer ]
    Ultrasound detection of fetal pole and heart rate of at least 7 weeks



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Ages Eligible for Study:   18 Years to 39 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Women younger than 39 at the time of cryopreservation
  2. Regular menstrual cycles of at least 26 days and at most 32 days.
  3. Women with no more than 3 failed prior embryo transfers
  4. Patients with embryos cryopreserved 48 hours after ovum pick up

Exclusion Criteria:

  1. Women with known uterine malformations or significant myomas
  2. Women with elevated Progesterone of at least 1.5 ng/mL for the duration of more than 72 hours before embryo transfer can be performed
  3. Women suspected of having endometrial pathology based on previous treatment cycles i.e. "thin endometrium", polyps, adhesions
  4. Women whose embryos did not survive the thawing process, i.e. no embryos available for transfer after thawing
  5. Women without follicular development

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): NCT02749344


Contacts
Contact: Amir Weiss, MD 97246495565 weiss_am@clalit.org.il

Locations
Israel
Emek Medical Center Recruiting
Afula, Israel
Contact: Amir Weiss, MD    972-4-6495565    weiss_am@clalit.org.il   
Principal Investigator: Amir Weiss, MD         
Sponsors and Collaborators
HaEmek Medical Center, Israel

Responsible Party: Amir Weiss, Dr., HaEmek Medical Center, Israel
ClinicalTrials.gov Identifier: NCT02749344     History of Changes
Other Study ID Numbers: 0074-15-EMC
First Posted: April 22, 2016    Key Record Dates
Last Update Posted: August 17, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Amir Weiss, HaEmek Medical Center, Israel:
Frozen Embryo Transfer, Progesterone, Endometrium

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