GnRH Agonist at Embryo Transfer: IVF Outcomes

NCT ID: NCT03544073

Last Updated: 2019-04-16

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE3
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-04-15
• Study Completion Date: 2021-06-30

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.

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).

Conditions

Infertility; Infertility, Female; Infertility, Male

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: PLACEBO_COMPARATOR

Saline Solution for Injection

Intervention Type: DRUG

Placebo arm will receive a saline injection

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.

Group Type: EXPERIMENTAL

Leuprolide Acetate

Intervention Type: DRUG

Treatment arm will receive a Leuprolide injection

Interventions

Saline Solution for Injection

Placebo arm will receive a saline injection

Intervention Type: DRUG

Leuprolide Acetate

Treatment arm will receive a Leuprolide injection

Intervention Type: DRUG

Other Intervention Names

NS; NSS; Lupron

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Maimonides Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Antonios Likourezos, M.P.H., M.A.

Role: STUDY_DIRECTOR

Maimonides Medical Center

Locations

Genesis Fertility Center

Brooklyn, New York, United States

Countries

United States

Other Identifiers

2018-03-14

Identifier Type: -

Identifier Source: org_study_id