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

NCT02200952 | Completed

• 1 other identifier: Luveris75UI
• Study Type: observational
• Target: 16
• Locations: 1 country
• Sites: 1

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

Conditions

Ovarian Hyperstimulation Syndrome

Keywords

OHSS; Oocytes triggering; GnRh agonist triggering; Luteal phase supplementation; recombinant LH

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Ealy and Late Ovarian Hyperstimulation Syndrome

  From 9 days after pick up to 12 weeks of gestation

Study Arms (1)

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

Drug: recombinant LH

Interventions

recombinant LH DRUG

recombinant LH twice/day for 10 days from pick up

Also known as: Luveris rLH by Merck Serono

Patients at risk of OHSS

Eligibility Criteria

• Age: 18 Years - 43 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Infertile patients undergoing controlled ovarian hyperstimulation

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• San Carlo Public Hospital, Potenza, Italy: lead

Study Sites (1)

San carlo Public Hospital

Potenza, Basilicate, 85100, Italy

Location

Related 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.

  PMID: 20979997 BACKGROUND

MeSH Terms

Conditions

Ovarian Hyperstimulation Syndrome

Condition Hierarchy (Ancestors)

Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Gonadal Disorders; Endocrine System Diseases

Study Officials

• Assunta Iuliano, MD, PhD

  San Carlo Public Hospital, Potenza, Italy

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Target Duration: 9 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: July 23, 2014
• First Posted: July 25, 2014
• Study Start: June 30, 2013
• Primary Completion: June 30, 2014
• Study Completion: June 30, 2014
• Last Updated: November 24, 2020

Record last verified: 2020-11

Locations

IT (1)