InfertilityNCT02449642
LH Hormone Pulsation in the Luteal Phase in GnRH Antagonist IVF Cycles Triggered by GnRH Agonist for Final Oocyte Maturation
An observational study of Infertility, run by Rambam Health Care Campus at 1 site in Israel.
Trial summary
Monitoring the LH pulsatility during the Luteal phase in GnRH antagonist IVF cycles triggered by GnRH agonist for final oocyte maturation. Read more about this study
- Who is it for?
- Ages 18 to 42 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Infertility
- How many people
- 10 participants
- Where
- 1 siteIsrael
- Study dates
- Jul 2015to Aug 2015
- Phase
- Observational
- 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 42 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: women aged 18-42 years old BMI < 32 kg/M2
Who may be able to join
- age: 18-42 years old BMI < 32 kg/m2
Who cannot join
- Hypogonadotropic hypogonadism
Trial locations and contacts
1 site in 1 country.
About this study
Monitoring the LH pulsatility during the Luteal phase in GnRH antagonist IVF cycles triggered by GnRH agonist for final oocyte maturation.
Read the detailed description
About two decades ago the GnRH antagonist has been used in IVF cycles to prevent premature LH surge. In recent review GNRH antagonist has been found comparable to GnRH agonist in term of live birth rate but with reduced risk of OHSS. another advantage of using GnRH antagonist is the ability to use GnRH agonist for final oocyte maturation which has been shown to nearly eliminate the risk of OHSS. The exact mechanism of this risk reduction is still unknown.
Our aim is to do a frequent blood tests every 20 minutes for 6 hours duration in the day of ovum pick up or the day of embryo transfer to measure the level of LH, estradiol and progesterone in women triggered with GnRH agonist for final oocyte maturation.
- Conditions
- Infertility
- Keywords
- luteinizing hormone pulsatility, estradiol level, progesterone level
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| group 1 | group 1 include 10 women in which blood tests will be taken on the day of oocyte pick up | |
| group 2 | group 2 include 10 women in which blood tests will be taken on the day of embryo transfer |
What is being measured
The primary outcome is the main question the study is designed to answer.
luteinizing hormone pulsatility frequency
Measured: 6 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2015 (estimated)
- Study startJul 2015
- Primary completionAug 2015
- Study completionAug 2015
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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rambam Health Care Campus
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, SAMER TANNUS MD, Rambam Health Care Campus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02449642
- Sponsor's protocol ID
- protocol1
- Status last verified
- Aug 2015
- First submitted
- 16 May 2015
- Last updated
- 18 Aug 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- LH Hormone Pulsation in the Luteal Phase in GnRH Antagonist IVF Cycles Triggered by GnRH Agonist for Final Oocyte Maturation
- ClinicalTrials.gov ID
- NCT02449642
- Acronym / sponsor ID
- protocol1
- Conditions
- Infertility
- Keywords
- luteinizing hormone pulsatility, estradiol level, progesterone level
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Rambam Health Care CampusUniversity, hospital or other
- Study start
- Jul 2015
- Primary completion
- Aug 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 20 May 2015 (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.
Monitoring the LH pulsatility during the Luteal phase in GnRH antagonist IVF cycles triggered by GnRH agonist for final oocyte maturation.
Detailed description
About two decades ago the GnRH antagonist has been used in IVF cycles to prevent premature LH surge. In recent review GNRH antagonist has been found comparable to GnRH agonist in term of live birth rate but with reduced risk of OHSS. another advantage of using GnRH antagonist is the ability to use GnRH agonist for final oocyte maturation which has been shown to nearly eliminate the risk of OHSS. The exact mechanism of this risk reduction is still unknown.
Our aim is to do a frequent blood tests every 20 minutes for 6 hours duration in the day of ovum pick up or the day of embryo transfer to measure the level of LH, estradiol and progesterone in women triggered with GnRH agonist for final oocyte maturation.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group 1 | – | –group 1 include 10 women in which blood tests will be taken on the day of oocyte pick up |
| group 2 | – | –group 2 include 10 women in which blood tests will be taken on the day of embryo transfer |
Who may qualify
- Ages
- 18 to 42 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- women aged 18-42 years old BMI < 32 kg/M2
Key inclusion criteria (1 listed)
- age: 18-42 years old BMI < 32 kg/m2
Key exclusion criteria (1 listed)
- Hypogonadotropic hypogonadism
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
luteinizing hormone pulsatility frequency
Time frame: 6 hours
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 18 Aug 2015.
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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?
An observational study of Infertility, run by Rambam Health Care Campus 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 18 Aug 2015. 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.
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?
luteinizing hormone pulsatility frequency (time frame: 6 hours). 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 18 Aug 2015.