- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03837223
RESCUE PROTOCOL AND FRESH EMBRYO TRANSFER
February 8, 2019 updated by: Istituto Clinico Humanitas
RESCUE PROTOCOL AND FRESH EMBRYO TRANSFER AFTER TRIGGER WITH ANALOGS OF GNRH: THE HUMANITAS PROTOCOL
Ovarian Hyperstimulation Syndrome (OHSS) is one of the most dangerous complications of Assisted Reproductive Technologies (ART) cycles.
The use in clinical practice of the GnRH antagonist has made it possible to perform the trigger with GnRH analogues reducing the risk of OHSS.
The trigger with analogue increases the Abortion Rate (AR) and reduces the Ongoing Pregnancy Rate (OPR), because the luteal phase in these cycles is particularly deficient.
To reduce this occurrence several studies have focused on the importance of support of the luteal phase.
The aims of study is to evaluate OPR and AR in patients at intermediate risk of OHSS (<18 recovered oocytes) which performed GnRH trigger and rescue protocol.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
271
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 38 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Sampling Method
Non-Probability Sample
Study Population
In HR patients (AMH> 3.5 ng / ml, AFC> 15 follicles and if more than 18 follicles with diam.
12mm to induction) the trigger was obtained with triptorelin 0.2 mg / sc.
In patients considered to be at intermediate risk of OHSS a rescue protocol has been implemented (HCG 1500 IU / sc the day of the pick up + estradiol 4 mg + vaginal progesterone 400 mg daily) and fresh embryo transfer.
Description
Inclusion Criteria:
AMH ( antimullerian hormone) > 3.5 ng / ml, AFC (antral follicles count) > 15 follicles and if more than 18 follicles with diam. 12mm to induction
Exclusion Criteria:
high risk of OHSS ( ovarian hyperstimulation syndrome)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
patients underwent "rescue protocols" and fresh embryotransfer
they were patients with good prognosis with a mean age of 34.13 ± 4.42 years, with a good ovarian reserve
|
In High Responder patients (HR) (more than 18 follicles with diameter ≥ 12mm at ovulation induction), the trigger was obtained with triptorelin 0.2 mg sc.
In this cohort if less of 18 oocytes were retrieved, patients were considered at intermediate risk of OHSS and fresh transfer was performed.
An adequate support of the luteal phase was initiated: HCG 1500 IU / sc the day of the pick up + estradiol 4 mg + vaginal progesterone 400 mg daily (Rescue protocol).
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
ongoing pregnancy rate (OPR)
Time Frame: 2013-2018
|
presence of gestational sac and fetal hearts beats showed on unltrasonography 7/8 weeks after embryo transfer
|
2013-2018
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Kupka MS, Ferraretti AP, de Mouzon J, Erb K, D'Hooghe T, Castilla JA, Calhaz-Jorge C, De Geyter C, Goossens V; European IVF-Monitoring Consortium, for the European Society of Human Reproduction and Embryology. Assisted reproductive technology in Europe, 2010: results generated from European registers by ESHREdagger. Hum Reprod. 2014 Oct 10;29(10):2099-113. doi: 10.1093/humrep/deu175. Epub 2014 Jul 27.
- Humaidan P, Kol S, Papanikolaou EG; Copenhagen GnRH Agonist Triggering Workshop Group. GnRH agonist for triggering of final oocyte maturation: time for a change of practice? Hum Reprod Update. 2011 Jul-Aug;17(4):510-24. doi: 10.1093/humupd/dmr008. Epub 2011 Mar 30.
- Fatemi HM, Garcia-Velasco J. Avoiding ovarian hyperstimulation syndrome with the use of gonadotropin-releasing hormone agonist trigger. Fertil Steril. 2015 Apr;103(4):870-3. doi: 10.1016/j.fertnstert.2015.02.004. Epub 2015 Feb 24.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 1, 2013
Primary Completion (Actual)
December 31, 2016
Study Completion (Actual)
December 31, 2016
Study Registration Dates
First Submitted
February 8, 2019
First Submitted That Met QC Criteria
February 8, 2019
First Posted (Actual)
February 12, 2019
Study Record Updates
Last Update Posted (Actual)
February 12, 2019
Last Update Submitted That Met QC Criteria
February 8, 2019
Last Verified
February 1, 2019
More Information
Terms related to this study
Other Study ID Numbers
- TRIGGER
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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