Luteal Phase Supplementation With Recombinant LH After GnRh Agonist Oocytes Triggering in Women at Risk of OHSS
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 16
- Locations
- 2
- Primary Endpoint
- Pregnancy Rate and Implantation Rate
Study Overview
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 Design
- Study Type
- Observational
- Observational Model
- Other
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to 43 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
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
Intervention: recombinant LH (Drug)
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- Ealy and Late Ovarian Hyperstimulation Syndrome(From 9 days after pick up to 12 weeks of gestation)
Investigators
Assunta Iuliano, MD
MD, PhD
San Carlo Public Hospital, Potenza, Italy