InfertilityPhase 4NCT01638026
Final Oocyte Maturation Via Administration of GnRH Agonists Followed By Luteal Support With hCG
A Phase 4 study testing TRIPTORELIN ACETATE, hCG in people with Infertility, run by HaEmek Medical Center, Israel at 1 site in Israel.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Infertility
- What is being tested?
- TRIPTORELIN ACETATE, hCG
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 93 participants
- Where
- 1 siteIsrael
- Study dates
- Sep 2012to Aug 2017
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- patients who are eligible for in vitro fertilization using an antagonist protocol
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Infertility
- Being tested
- TRIPTORELIN ACETATE, hCG
- Keywords
- Gnrh agonist
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TRIPTORELIN ACETATE, hCGDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Gnrh agonist , hcg | Experimental | Gnrh agonist for final oocyte maturation, hcg for luteal support Receives: Drug: TRIPTORELIN ACETATE, hCG |
What is being measured
The primary outcome is the main question the study is designed to answer.
fertilization rate
Measured: 4 weeks
Secondary outcomes (1)
satisfaction, no. of oocyte, pregnancy rate, no. of embryos, quality of embryos
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2012 (estimated)
- Study startSep 2012
- Primary completionJul 2017
- Study completionAug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfertilityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 93 participants (actual)
Sponsor and investigators
- Lead sponsor
- HaEmek Medical Center, Israel
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ronit Beck Fruchter, HaEmek Medical Center, Israel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01638026
- Sponsor's protocol ID
- emc-0060-12-CTIL
- Status last verified
- Aug 2017
- First submitted
- 8 Jul 2012
- Last updated
- 29 Aug 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Final Oocyte Maturation Via Administration of GnRH Agonists Followed By Luteal Support With hCG
- ClinicalTrials.gov ID
- NCT01638026
- Acronym / sponsor ID
- emc-0060-12-CTIL
- Conditions
- Infertility
- Keywords
- Gnrh agonist
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 93 participants (actual)
- Lead sponsor
- HaEmek Medical Center, IsraelUniversity, hospital or other
- Study start
- Sep 2012
- Primary completion
- Jul 2017 (actual)
- Study completion
- Aug 2017 (actual)
- First posted
- 11 Jul 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Gnrh agonist , hcg | Experimental | Drug: TRIPTORELIN ACETATE, hCGGnrh agonist for final oocyte maturation, hcg for luteal support |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- patients who are eligible for in vitro fertilization using an antagonist protocol
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TRIPTORELIN ACETATE, hCGIn 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. | Drug | Gnrh agonist , hcg |
Primary outcome
fertilization rate
Time frame: 4 weeks
1 secondary outcome
satisfaction, no. of oocyte, pregnancy rate, no. of embryos, quality of embryos
Time frame: 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing TRIPTORELIN ACETATE, hCG in people with Infertility, run by HaEmek Medical Center, Israel at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
fertilization rate (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Aug 2017.