Clinical trial NCT02200952: Luteal Phase Supplementation With Recombinant LH After GnRh Agonist Oocytes Triggering in Women at Risk of OHSS
Official title: Luteal Phase Supplementation With Recombinant LH After GnRh Agonist Oocytes Triggering in Women at Risk of OHSS
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ovarian Hyperstimulation Syndrome
Keywords: OHSS
Oocytes triggering
GnRh agonist triggering
Luteal phase supplementation
recombinant LH
Lead sponsor: San Carlo Public Hospital, Potenza, Italy
Sponsor class: OTHER
First posted: 2014-07-25
Enrollment: 16
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 43
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Infertile patients undergoing controlled ovarian hyperstimulation

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.

Eligibility criteria: 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

Primary outcomes:
measure: Pregnancy Rate and Implantation Rate
timeFrame: From 14 days after the pick up to six weeks of gestation
Secondary outcomes:
measure: Ealy and Late Ovarian Hyperstimulation Syndrome
timeFrame: From 9 days after pick up to 12 weeks of gestation
Other outcomes:
Locations:
city: Potenza
country: Italy
facility: San Carlo Public Hospital
state: Basilicata
city: Potenza
country: Italy
facility: San carlo Public Hospital
state: Basilica
Study officials:
affiliation: San Carlo Public Hospital, Potenza, Italy
name: Assunta Iuliano, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.