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Completed

NCT Number: NCT02200952

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

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

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Key information

Conditions

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

Age range

18 year–43 year

Sex eligibility

Female

Study type

Observational

Primary location

San carlo Public Hospital

Potenza, Basilicate, 85100, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Recombinant LH

Drug

recombinant LH twice/day for 10 days from pick up

Other names: Luveris rLH by Merck Serono

Primary outcomes

  1. 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

  1. Ealy and Late Ovarian Hyperstimulation Syndrome

    Time frame: 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

Sponsors and collaborators

Lead sponsor

San Carlo Public Hospital, Potenza, Italy

Other

Registry information

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Jul 25, 2014
Registry last updated
Nov 24, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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