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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Ovarian Hyperstimulation Syndrome

Intervention / Treatment
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* Drug: recombinant LH


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 43 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients at risk of OHSS<br>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<br>* recombinant LH twice/day for 10 days from pick up<br>* Other names: Luveris rLH by Merck Serono;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Oocytes triggering, GnRh agonist triggering, Luteal phase supplementation, recombinant LH, OHSS