Premature Progesterone RiseNCT03001492
Does Premature Luteinization Matter?
An observational study of Premature Progesterone Rise, run by Assiut University at 1 site in Egypt.
Trial summary
Elevation of serum progesterone on the day of ovulation triggering in IVF/ICSI cycles is suggested to be associated with compromized outcomes. Others found that this rise didnot affect the IVF/ICSI outcomes. It is still controversal if premature luteinization would affect the IVF/ICSI outcomes. Read more about this study
- Who is it for?
- Ages 18 to 42 years, women only
- Conditions the study is for
- Premature Progesterone Rise
- How many people
- 200 participants
- Where
- 1 siteEgypt
- Study dates
- Dec 2016to Jun 2018
- 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
- No healthy volunteers
- Adult
Study population: All the women undergo controlled ovarian hyperstimulation for IVF/ICSI. only fresh cycles will be involved
Who may be able to join
- Planned fresh Embryo transfer
Who cannot join
- Cancelation of the embryo transfer for any reason
Trial locations and contacts
1 site in 1 country.
Osama Abdalmageed contact
Egypt1 site, 1 recruiting
- Recruiting
Osama Abdalmageed
Asyut, Non-US/Non-Canadian, 71111
Osama Abdalmageed, drosamast1981@gmail.com
About this study
Official title: Does Measurement of Serum Progesterone on the Day of Trigger Matter?
Elevation of serum progesterone on the day of ovulation triggering in IVF/ICSI cycles is suggested to be associated with compromized outcomes. Others found that this rise didnot affect the IVF/ICSI outcomes. It is still controversal if premature luteinization would affect the IVF/ICSI outcomes.
- Conditions
- Premature Progesterone Rise
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical pregnacy rate
Measured: 14 days after the day of embryo transfer (ET)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2016 (estimated)
- Study startDec 2016
- Primary completionJun 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Premature Progesterone RiseStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Osama Saber Thabet Abdalmageed, Assiut University
- Investigators
- Osama Abdalmageed, Principal investigator, Women health center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03001492
- Sponsor's protocol ID
- Progesterone
- Status last verified
- Dec 2016
- First submitted
- 17 Dec 2016
- Last updated
- 26 Dec 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Sonmezer M, Pelin Cil A, Atabekoglu C, Ozkavukcu S, Ozmen B. Does premature luteinization or early surge of LH impair cycle outcome? Report of two successful outcomes. J Assist Reprod Genet. 2009 Mar;26(2-3):159-63. doi: 10.1007/s10815-009-9299-5. Epub 2009 Feb 18.
PubMed 19224360
Study at a glance
From the registry record, last updated by the sponsor on 26 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Measurement of Serum Progesterone on the Day of Trigger Matter?
- ClinicalTrials.gov ID
- NCT03001492
- Acronym / sponsor ID
- Progesterone
- Conditions
- Premature Progesterone Rise
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Dec 2016
- Primary completion
- Jun 2018 (estimated)
- First posted
- 23 Dec 2016 (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.
Elevation of serum progesterone on the day of ovulation triggering in IVF/ICSI cycles is suggested to be associated with compromized outcomes. Others found that this rise didnot affect the IVF/ICSI outcomes. It is still controversal if premature luteinization would affect the IVF/ICSI outcomes.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 42 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- All the women undergo controlled ovarian hyperstimulation for IVF/ICSI. only fresh cycles will be involved
Key inclusion criteria (1 listed)
- Planned fresh Embryo transfer
Key exclusion criteria (1 listed)
- Cancelation of the embryo transfer for any reason
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
Clinical pregnacy rate
Time frame: 14 days after the day of embryo transfer (ET)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Dec 2016.
- Background: PubMed 19224360Sonmezer M, Pelin Cil A, Atabekoglu C, Ozkavukcu S, Ozmen B. Does premature luteinization or early surge of LH impair cycle outcome? Report of two successful outcomes. J Assist Reprod Genet. 2009 Mar;26(2-3):159-63. doi: 10.1007/s10815-009-9299-5. Epub 2009 Feb 18.
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.
Osama Abdalmageed contact
Osama Abdalmageed principal investigator
Women health center
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 Premature Progesterone Rise, run by Assiut University at 1 site in Egypt.
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: status not confirmed, as of the sponsor's last update on 26 Dec 2016. 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 Egypt. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Osama Abdalmageed (drosamast1981@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical pregnacy rate (time frame: 14 days after the day of embryo transfer (ET)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03001492, which also lists 1 linked publication.
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 26 Dec 2016.