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

Ovarian Hyperstimulation Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02200952
• Other study ID #: Luveris75UI
• Status: Completed
• Start date: June 30, 2013
• Est. completion date: June 30, 2014

Study information

• Verified date: November 2020
• Source: San Carlo Public Hospital, Potenza, Italy
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: June 30, 2014
• Est. primary completion date: June 30, 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 43 Years

Eligibility

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

Related Conditions & MeSH terms

• Ovarian Hyperstimulation Syndrome

Intervention

Drug:
• recombinant LH
recombinant LH twice/day for 10 days from pick up

Locations

Country	Name	City	State
Italy	San Carlo Public Hospital	Potenza	Basilicata
Italy	San carlo Public Hospital	Potenza	Basilica

Sponsors (1)

Lead Sponsor	Collaborator
San Carlo Public Hospital, Potenza, Italy

Country where clinical trial is conducted

Italy, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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