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GnRH Agonist at Embryo Transfer: IVF Outcomes (GRAET)

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ClinicalTrials.gov Identifier: NCT03544073
Recruitment Status : Withdrawn (The investigators were not able to get grant funding for this study.)
First Posted : June 1, 2018
Last Update Posted : April 16, 2019
Sponsor:
Information provided by (Responsible Party):
Maimonides Medical Center

Study Description
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Brief Summary:
In ART (assisted reproductive technology) cycles, embryos are transferred to a woman's uterus after in-vitro fertilization (IVF) in a laboratory. Usually, hormones (progesterone) are given to the patient after transferring the embryo, as a supplement, in order to mimic the natural hormones that would normally be secreted in an unassisted pregnancy. This study will identify whether additional gonadotropin-releasing hormone (GnRH-agonist) administration, a natural hormone secreted from the hypothalamus, will improve the clinical pregnancy and live birth rates when using IVF.

Condition or disease Intervention/treatment Phase
Infertility Infertility, Female Infertility, Male Drug: Saline Solution for Injection Drug: Leuprolide Acetate Phase 3

Detailed Description:

This is a randomized, double-blinded, placebo-controlled study. On the day of embryo transfer (5-6 days after a fresh egg retrieval and on the 6th day of progesterone administration in a frozen embryo transfer cycle), patients will receive either a single injection of 20 Units (1mg) of Lupron or an identical placebo injection. Patients undergoing day 3 embryo transfers will not be eligible and will not be randomized.

Randomization will be in 22 blocks of 20 patients. Based on the power analysis with a power of 0.8 and alpha-error of 0.05, the investigators will need to enroll 352 patients, so the investigators will recruit 440 to account for attrition.

Randomization scheme will be computed via a computerized program accessible at randomization.com or via SPSS. There will be one randomization: both fresh and frozen embryo cycles will be randomized in the same group. Sequential cards with randomization allocation will be placed in doubly sealed, opaque envelopes, with a single sheet confirming eligibility status. Confirmation of the presence of the signed Informed Consent will be in the first envelope. The second envelope will be opened after there is confirmation that the patient is eligible and consented. This envelope will have a card stating the group the patient has been assigned to, with blank spaces designated to record patient information. This card will be completed by the study staff and saved for reference purposes. The card will state the group that the patient was randomized to, the date of embryo transfer, the patient's medical record number, name, and cycle type. There will also be a log book to record the information and medication lot numbers.

Injections will be prepared at the time of randomization by the research coordinator and will be administered by the clinical RN, who will not know its contents. The clinical staff assessing and planning care of the patient (attending physicians and nurses) will not know the contents of the syringe (either Lupron 20 IU or the same amount of normal saline).

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Masking Description: Patient and provider will both be blinded to the medication that the patient receives.
Primary Purpose: Treatment
Official Title: Does a GnRH Agonist Given at Embryo Transfer Improve Clinical Pregnancy and Live Birth Rates of Women Undergoing In-Vitro Fertilization?
Estimated Study Start Date : April 15, 2019
Estimated Primary Completion Date : June 30, 2020
Estimated Study Completion Date : June 30, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pregnancy

Arms and Interventions
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Arm Intervention/treatment
Placebo Comparator: Saline Solution for Injection
This arm will receive a one-time subcutaneous injection of 0.4mL normal saline solution at the time of embryo transfer. This arm will continue to receive all the same treatments that everyone routinely receives for the IVF cycle, e.g. estrogen and progesterone supplements.
 Drug: Saline Solution for Injection
Placebo arm will receive a saline injection
Other Names:
  • NS
  • NSS
Experimental: Leuprolide Acetate
This arm will receive a one-time subcutaneous injection of 0.4U (0.2mg=0.4mL) Leuprolide acetate at the time of embryo transfer. This arm will continue to receive all the same routine treatments for the IVF cycle, e.g. estrogen and progesterone supplements.
 Drug: Leuprolide Acetate
Treatment arm will receive a Leuprolide injection
Other Name: Lupron


Outcome Measures
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Primary Outcome Measures :
  1. Live birth rate [ Time Frame: 2 years ]
    Percentage of live births for all patients included.


Secondary Outcome Measures :
  1. Miscarriage rate [ Time Frame: 2 years ]
    Percentage of pregnancies that ended in miscarriage

  2. Clinical pregnancy rate [ Time Frame: 2 years ]
    Percentage of patients who had a clinical pregnancy, i.e. positive urine pregnancy test


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Women undergoing in-vitro fertilization who are receiving an embryo transfer of a day 5 blastocyst

Exclusion Criteria:

  • Those who have a contraindication to receiving the medication
Contacts and Locations
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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): NCT03544073


Locations
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United States, New York
Genesis Fertility Center
Brooklyn, New York, United States, 11204
Sponsors and Collaborators
Maimonides Medical Center
Investigators
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Study Director: Antonios Likourezos, M.P.H., M.A. Maimonides Medical Center
More Information
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Responsible Party: Maimonides Medical Center
ClinicalTrials.gov Identifier: NCT03544073    
Other Study ID Numbers: 2018-03-14
First Posted: June 1, 2018    Key Record Dates
Last Update Posted: April 16, 2019
Last Verified: April 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Maimonides Medical Center:
in-vitro fertilization
Additional relevant MeSH terms:
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Infertility
Infertility, Female
Infertility, Male
Leuprolide
Fertility Agents, Female
 Fertility Agents
Reproductive Control Agents
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents