Ovarian Hyperstimulation SyndromeNCT02200952
Luteal Phase Supplementation With Recombinant LH After GnRh Agonist Oocytes Triggering in Women at Risk of OHSS
An observational study of Ovarian Hyperstimulation Syndrome, run by San Carlo Public Hospital, Potenza, Italy at 1 site in Italy.
Trial summary
The purpose of this study is to prove that luteal phase supplementation with recombinant LH can solve the luteal phase deficiency after Gnrh agonist oocytes triggering in women at risk of OHSS Read more about this study
- Who is it for?
- Ages 18 to 43 years, women only
- Conditions the study is for
- Ovarian Hyperstimulation Syndrome
- What is being tested?
- recombinant LH
- How many people
- 16 participants
- Where
- 1 siteItaly
- Study dates
- 30 Jun 2013to 30 Jun 2014
- How long will I take part?
- 9 Months
- 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 43 years
- Women only
- No healthy volunteers
- Adult
Study population: Infertile patients undergoing controlled ovarian hyperstimulation
Who may be able to join
- patients with an oestradiol > 4000 pg/ml on the oocytes triggering day
- patient with more than 24 follicles of diameter greater than 12 mm on the oocytes triggering day
Who cannot join
- patients with no risk of OHSS on the oocytes triggering day
- patients with an oestradiol < 4000 pg/ml on the oocytes triggering day
- patient with less than 24 follicles of diameter greater than 12 mm on the oocytes triggering day
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to prove that luteal phase supplementation with recombinant LH can solve the luteal phase deficiency after Gnrh agonist oocytes triggering in women at risk of OHSS
Read the detailed description
The investigators enrolled patients, undergoing controlled ovarian stimulation for an IVF/ICSI cycles, who on the day of oocytes triggering were at risk of OHSS.
These patients had an estradiol > 4000 pg/ml and more than 24 follicles with a diameter greater than 12 mm.
The investigators used 0,2 mg of triptorelin for the oocytes triggering and supplemented the luteal phase with recombinant LH at a dose of 75 UI twice/day for 10 days and vaginal gel progesterone and oral oestradiol for 14 days The investigators measured bhCG at 14 days from the pick up. In case of positive bhCG we have defined the IVF/ICSI outcome: Pregnancy Rate and Implantation Rate.
- Conditions
- Ovarian Hyperstimulation Syndrome
- Being tested
- recombinant LH
- Keywords
- OHSS, Oocytes triggering, GnRh agonist triggering, Luteal phase supplementation, recombinant LH
- Medical subject headings
- Ovarian Hyperstimulation Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
recombinant LHDrug
Also called Luveris rLH by Merck Serono
recombinant LH twice/day for 10 days from pick up
| Study group | Role | What they receive |
|---|---|---|
| Patients at risk of OHSS | Patients at risk of OHSS on the oocytes triggering day with an oestradiol > 4000pg/ml or a number of follicles greater than 24 of a diameter greater than 12 mm Receives: Drug: recombinant LH |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pregnancy Rate and Implantation Rate
We measured bhCG after 14 days from the pick up. In presence of a positive value of bhCG we evaluated IVF/ICSI outcome through the pregnancy rate and implantation rate.
Measured: From 14 days after the pick up to six weeks of gestation
Secondary outcomes (1)
Ealy and Late Ovarian Hyperstimulation Syndrome
We evaluated early and late ovarian hyperstimulation syndrome according the practice committee of ASRM 2008 and Current Clinical Guideline for OHSS of 2010
Measured: From 9 days after pick up to 12 weeks of gestation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2014 (estimated)
- Study start30 Jun 2013
- Primary completion30 Jun 2014
- Study completion30 Jun 2014
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 Ovarian Hyperstimulation SyndromeStudies 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
- Other
- Time perspective
- Prospective
- Enrolment
- 16 participants (actual)
- Target duration
- 9 Months
Sponsor and investigators
- Lead sponsor
- San Carlo Public Hospital, Potenza, Italy
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Assunta Iuliano, MD, San Carlo Public Hospital, Potenza, Italy
- Investigators
- Assunta Iuliano, MD, PhD, Principal investigator, San Carlo Public Hospital, Potenza, Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02200952
- Sponsor's protocol ID
- Luveris75UI
- Status last verified
- Nov 2020
- First submitted
- 23 Jul 2014
- Last updated
- 24 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
Papanikolaou EG, Verpoest W, Fatemi H, Tarlatzis B, Devroey P, Tournaye H. A novel method of luteal supplementation with recombinant luteinizing hormone when a gonadotropin-releasing hormone agonist is used instead of human chorionic gonadotropin for ovulation triggering: a randomized prospective proof of concept study. Fertil Steril. 2011 Mar 1;95(3):1174-7. doi: 10.1016/j.fertnstert.2010.09.023. Epub 2010 Oct 27.
PubMed 20979997
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Luteal Phase Supplementation With Recombinant LH After GnRh Agonist Oocytes Triggering in Women at Risk of OHSS
- ClinicalTrials.gov ID
- NCT02200952
- Acronym / sponsor ID
- Luveris75UI
- Conditions
- Ovarian Hyperstimulation Syndrome
- Keywords
- OHSS, Oocytes triggering, GnRh agonist triggering, Luteal phase supplementation, recombinant LH
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- San Carlo Public Hospital, Potenza, ItalyUniversity, hospital or other
- Study start
- 30 Jun 2013 (actual)
- Primary completion
- 30 Jun 2014 (actual)
- Study completion
- 30 Jun 2014 (actual)
- First posted
- 25 Jul 2014 (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.
The purpose of this study is to prove that luteal phase supplementation with recombinant LH can solve the luteal phase deficiency after Gnrh agonist oocytes triggering in women at risk of OHSS
Detailed description
The investigators enrolled patients, undergoing controlled ovarian stimulation for an IVF/ICSI cycles, who on the day of oocytes triggering were at risk of OHSS.
These patients had an estradiol > 4000 pg/ml and more than 24 follicles with a diameter greater than 12 mm.
The investigators used 0,2 mg of triptorelin for the oocytes triggering and supplemented the luteal phase with recombinant LH at a dose of 75 UI twice/day for 10 days and vaginal gel progesterone and oral oestradiol for 14 days The investigators measured bhCG at 14 days from the pick up. In case of positive bhCG we have defined the IVF/ICSI outcome: Pregnancy Rate and Implantation Rate.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 9 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients at risk of OHSS | – | Drug: recombinant LHPatients at risk of OHSS on the oocytes triggering day with an oestradiol > 4000pg/ml or a number of follicles greater than 24 of a diameter greater than 12 mm |
Who may qualify
- Ages
- 18 to 43 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Infertile patients undergoing controlled ovarian hyperstimulation
Key inclusion criteria (2 listed)
- patients with an oestradiol > 4000 pg/ml on the oocytes triggering day
- patient with more than 24 follicles of diameter greater than 12 mm on the oocytes triggering day
Key exclusion criteria (3 listed)
- patients with no risk of OHSS on the oocytes triggering day
- patients with an oestradiol < 4000 pg/ml on the oocytes triggering day
- patient with less than 24 follicles of diameter greater than 12 mm on the oocytes triggering day
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 |
|---|---|---|
| recombinant LHAlso: Luveris rLH by Merck Seronorecombinant LH twice/day for 10 days from pick up | Drug | Patients at risk of OHSS |
Primary outcome
Pregnancy Rate and Implantation Rate
Time frame: From 14 days after the pick up to six weeks of gestation
We measured bhCG after 14 days from the pick up. In presence of a positive value of bhCG we evaluated IVF/ICSI outcome through the pregnancy rate and implantation rate.
1 secondary outcome
Ealy and Late Ovarian Hyperstimulation Syndrome
Time frame: From 9 days after pick up to 12 weeks of gestation
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 24 Nov 2020.
- Background: PubMed 20979997Papanikolaou EG, Verpoest W, Fatemi H, Tarlatzis B, Devroey P, Tournaye H. A novel method of luteal supplementation with recombinant luteinizing hormone when a gonadotropin-releasing hormone agonist is used instead of human chorionic gonadotropin for ovulation triggering: a randomized prospective proof of concept study. Fertil Steril. 2011 Mar 1;95(3):1174-7. doi: 10.1016/j.fertnstert.2010.09.023. Epub 2010 Oct 27.
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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.
Assunta Iuliano, MD, PhD principal investigator
San Carlo Public Hospital, Potenza, Italy
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 Ovarian Hyperstimulation Syndrome, run by San Carlo Public Hospital, Potenza, Italy at 1 site in Italy.
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 2 inclusion and 3 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 24 Nov 2020. 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 Italy. 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?
Pregnancy Rate and Implantation Rate (time frame: From 14 days after the pick up to six weeks of gestation). 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 NCT02200952, 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 24 Nov 2020.