Hemek medical centre
Afula, 18101, Israel
NCT Number: NCT01638026
Study Objectives:
1. To prove that the use of GnHR agonist for final oocyte maturation results in a higher percentage of mature oocytes than the use of hCG. 2. To show an advantage in women's satisfaction in the proposed protocol versus the standard antagonist protocol In the study group women will receive GnRH agonist for oocyte maturation, followed by ovum pick-up which will be performed 35 hours later. Embryo transfer will be performed 48-72 hours after ovum pick-up. Luteal support will include HCG 1500 IU. Blood samples for BHCG, progesterone and estradiol will be obtained 14 days after embryo transfer.
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Notify Me18 year–45 year
Female
Interventional
Phase 4
Afula, 18101, Israel
Final Oocyte Maturation via Administration of GnRH Agonists Followed By Luteal Support with hCG
The use of Gonadotropin-Releasing Hormone (GnRH) antagonists in in vitro fertilization (IVF) stimulation protocols holds many advantages over the long protocol with GnRH agonists. One of the advantages includes the ability to use GnRH agnosits for final oocyte maturation, thus minimizing the risk of ovarian hyperstimulation syndrome.
Study Objectives:
Inclusion criteria
- patients who are eligible for in vitro fertilization using an antagonist protocol Exclusion criteria - patients diagnosed with hypogonadotrophic hypogonadism, sensitivity to any of the drugs used in the study A patient enrolled in the study who, as a result of ovarian stimulation, responds in a way that puts her in risk of developing ovarian hyperstimulation, will be ultimately excluded from the study. For the purpose of this study, this response includes estradiol levels higher than 2500 pg/ml, fifteen or more follicles over 12 mm in diameter, or any other case in which the treating physician has reason to suspect an eventual hyperstimulation reaction.
Study Protocol:
Informed consent will be obtained at the beginning of the treatment and up until the day of final oocyte maturation.
Oocyte stimulation in both groups will be achieved with recombinant FSH. Dose will be determined according to our department's protocol and response to previous treatments. GnRH antagonists will be added when leading follicle reaches 13-14 mm in diameter. Final oocyte maturation will be initiated when at least 2 follicles reach a diameter of 17 mm.
In the study group women will receive GnRH agonist (decapeptyl 0.2 mg) for oocyte maturation, followed by ovum pick-up which will be performed 35 hours later. Embryo transfer will be performed 48-72 hours after ovum pick-up. Luteal support will include HCG 1500 IU. Blood samples for BHCG, progesterone and estradiol will be obtained 14 days after embryo transfer. Prior to getting results from these tests, women will be asked to fill out a questionnaire regarding their satisfaction from the protocol protocol amendment: to add a prospective control group
We would like to add thromboelastography test. Our aim is to check whether triggering ovulation with GNRHa alters the clotting dynamics and reduce the risk for thromboembolic events.
Inclusion criteria
IVF patients who are:
Exclusion criteria
IVF patients who:
Study protocol:
Suitable patients would be offered to participate in the study and to sign informed consent. We will ask the participant to take 3 blood tests (5-8 ml blood each):
The study was approved by the local Ethics Committee. The thromboelastography test is available in the local hematologic laboratory. The cost of a single test is 50 NIS. We plan to recruit 50 patients.
Outcome:
Primary:
Secondary:
The change in the coagulation profile in relation with:
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
In the study group women will receive GnRH agonist (decapeptyl 0.2 mg) for oocyte maturation, followed by ovum pick-up which will be performed 35 hours later. Embryo transfer will be performed 48-72 hours after ovum pick-up. Luteal support will include HCG 1500 IU.
Time frame: 4 weeks
Time frame: 4 weeks
HaEmek Medical Center, Israel
Other
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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