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

Completed

• Conditions: Ovarian Hyperstimulation Syndrome
• Interventions: Drug: recombinant LH

• Registration Number: NCT02200952
• Lead Sponsor: San Carlo Public Hospital, Potenza, Italy

Brief 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

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 Timeline

• Study Start: 2013-06-30
• Primary Completion: 2014-06-30
• Study Completion: 2014-06-30
• Study First Submitted: 2014-07-23
• Study First Submitted QC: 2014-07-24
• Study First Posted: 2014-07-25
• Status Verified: 2020-11
• Last Update Submitted: 2020-11-22
• Last Update Posted: 2020-11-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 16

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients at risk of OHSS	recombinant LH	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

Primary Outcome Measures

Name	Time	Method
Pregnancy Rate and Implantation Rate	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.

Secondary Outcome Measures

Name	Time	Method
Ealy and Late Ovarian Hyperstimulation Syndrome	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

Trial Locations

Locations (2)

San Carlo Public Hospital; 🇮🇹 Potenza, Basilicata, Italy

San carlo Public Hospital; 🇮🇹 Potenza, Basilica, Italy