Final Oocyte Maturation Via Administration of GnRH Agonists Followed By Luteal Support With hCG
Primary Purpose
Infertility
Status
Completed
Phase
Phase 4
Locations
Israel
Study Type
Interventional
Intervention
TRIPTORELIN ACETATE, hCG
Sponsored by
About this trial
This is an interventional treatment trial for Infertility focused on measuring Gnrh agonist
Eligibility Criteria
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.
Sites / Locations
- Hemek medical centre
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Gnrh agonist , hcg
Arm Description
Gnrh agonist for final oocyte maturation, hcg for luteal support
Outcomes
Primary Outcome Measures
fertilization rate
Secondary Outcome Measures
satisfaction, no. of oocyte, pregnancy rate, no. of embryos, quality of embryos
Full Information
NCT ID
NCT01638026
First Posted
July 8, 2012
Last Updated
August 27, 2017
Sponsor
HaEmek Medical Center, Israel
1. Study Identification
Unique Protocol Identification Number
NCT01638026
Brief Title
Final Oocyte Maturation Via Administration of GnRH Agonists Followed By Luteal Support With hCG
Official Title
Final Oocyte Maturation Via Administration of GnRH Agonists Followed By Luteal Support With hCG
Study Type
Interventional
2. Study Status
Record Verification Date
August 2017
Overall Recruitment Status
Completed
Study Start Date
September 2012 (undefined)
Primary Completion Date
July 2017 (Actual)
Study Completion Date
August 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
HaEmek Medical Center, Israel
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Study Objectives:
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.
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.
Detailed Description
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:
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.
To show an advantage in women's satisfaction in the proposed protocol versus the standard antagonist protocol
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:
treated with the GNRH antagonist protocol
at low risk for OHSS
signed informed consent
Exclusion criteria:
IVF patients who:
are treated with the GNRH agonist protocol
infertile due to hypogonadotrophic hypogonadism
are at high risk of OHSS.
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):
Before starting the hormonal treatment for ovulation induction.
During the hormonal treatment, 48-72 hours before ovum pickup.
At the day of the ovum pick up, about 36 hours after induction of final oocyte maturation using hCG or Gnrh agonist.
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:
The change in the coagulation profile (the thromboelastogram) along the ovulation induction treatment.
The difference in the coagulation profile between the two different protocols, the GNRHa Vs the hCG.
Secondary:
The change in the coagulation profile in relation with:
estradiol levels
the number of oocytes
the number of embryos.
the achievement of pregnancy
the occurrence of OHSS.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility
Keywords
Gnrh agonist
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
93 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Gnrh agonist , hcg
Arm Type
Experimental
Arm Description
Gnrh agonist for final oocyte maturation, hcg for luteal support
Intervention Type
Drug
Intervention Name(s)
TRIPTORELIN ACETATE, hCG
Intervention Description
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.
Primary Outcome Measure Information:
Title
fertilization rate
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
satisfaction, no. of oocyte, pregnancy rate, no. of embryos, quality of embryos
Time Frame
4 weeks
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Hemek medical centre
City
Afula
ZIP/Postal Code
18101
Country
Israel
12. IPD Sharing Statement
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Final Oocyte Maturation Via Administration of GnRH Agonists Followed By Luteal Support With hCG
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