Luteal Phase Supplementation With Recombinant LH After GnRh Agonist Oocytes Triggering in Women at Risk of OHSS

November 22, 2020 updated by: Assunta Iuliano, MD, San Carlo Public Hospital, Potenza, Italy
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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

16

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • Basilica
      • Potenza, Basilica, Italy, 85100
        • San carlo Public Hospital
    • Basilicata
      • Potenza, Basilicata, Italy, 85100
        • San carlo Public Hospital

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 43 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Probability Sample

Study Population

Infertile patients undergoing controlled ovarian hyperstimulation

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

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

  • Observational Models: Other
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
Drug: recombinant LH
recombinant LH twice/day for 10 days from pick up
Other Names:
  • Luveris rLH by Merck Serono

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
From 14 days after the pick up to six weeks of gestation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Ealy and Late Ovarian Hyperstimulation Syndrome
Time Frame: From 9 days after pick up to 12 weeks of gestation
We evaluated early and late ovarian hyperstimulation syndrome according the practice committee of ASRM 2008 and Current Clinical Guideline for OHSS of 2010
From 9 days after pick up to 12 weeks of gestation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

San Carlo Public Hospital, Potenza, Italy

Investigators

  • Principal Investigator: Assunta Iuliano, MD, PhD, San Carlo Public Hospital, Potenza, Italy

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

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)

June 30, 2013

Primary Completion (Actual)

June 30, 2014

Study Completion (Actual)

June 30, 2014

Study Registration Dates

First Submitted

July 23, 2014

First Submitted That Met QC Criteria

July 24, 2014

First Posted (Estimate)

July 25, 2014

Study Record Updates

Last Update Posted (Actual)

November 24, 2020

Last Update Submitted That Met QC Criteria

November 22, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Luveris75UI

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.

Clinical Trials on Ovarian Hyperstimulation Syndrome

Clinical Trials on recombinant LH

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Argentina

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe