GnRH Agonist at Embryo Transfer: IVF Outcomes

Infertility Clinical Trial

— GRAET  

Official title:

Does a GnRH Agonist Given at Embryo Transfer Improve Clinical Pregnancy and Live Birth Rates of Women Undergoing In-Vitro Fertilization?

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03544073
• Other study ID #: 2018-03-14
• Status: Withdrawn
• Phase: Phase 3
• Start date: April 15, 2019
• Est. completion date: June 30, 2021

Study information

• Verified date: April 2019
• Source: Maimonides Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: June 30, 2021
• Est. primary completion date: June 30, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Infertility
• Infertility, Female
• Infertility, Male

Intervention

Drug:
• Saline Solution for Injection
Placebo arm will receive a saline injection
• Leuprolide Acetate
Treatment arm will receive a Leuprolide injection

Locations

Country	Name	City	State
United States	Genesis Fertility Center	Brooklyn	New York

Sponsors (1)

Lead Sponsor	Collaborator
Maimonides Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Live birth rate	Percentage of live births for all patients included.	2 years
Secondary	Miscarriage rate	Percentage of pregnancies that ended in miscarriage	2 years
Secondary	Clinical pregnancy rate	Percentage of patients who had a clinical pregnancy, i.e. positive urine pregnancy test	2 years