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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.
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 our power analysis with a power of 0.8 and alpha-error of 0.05, we will need to enroll 352 patients, so we 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 our 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).
Saline Solution for Injection, Leuprolide Acetate
Not yet recruiting
Maimonides Medical Center
Published on BioPortfolio: 2018-06-07T23:55:10-0400
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Hypertonic sodium chloride solution. A solution having an osmotic pressure greater than that of physiologic salt solution (0.9 g NaCl in 100 ml purified water).
Intradermal injection of a heated (pasteurized) saline suspension of sarcoid tissue obtained from a sarcoid spleen or lymph node. In patients with active sarcoidosis a dusky red nodule develops slowly over the next few weeks at the injection site. Histologic examination, an essential part of the complete test, reveals sarcoid tissue.
A synthetic progestin that is derived from 17-hydroxyprogesterone. It is a long-acting contraceptive that is effective both orally or by intramuscular injection and has also been used to treat breast and endometrial neoplasms.
Inability to reproduce after a specified period of unprotected intercourse. Reproductive sterility is permanent infertility.
Any liquid used to replace blood plasma, usually a saline solution, often with serum albumins, dextrans or other preparations. These substances do not enhance the oxygen- carrying capacity of blood, but merely replace the volume. They are also used to treat dehydration.
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