Effects of Recombinant LH in Patients With Repeated Implantation Failure

NCT03204253 | Completed

• 1 other identifier: Biofertility
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief Summary

Pregnancy rates fall dramatically in women after 35 years undergoing to IVF or ICSI. While ovarian aging obviously plays the major role in this phenomenon, over suppression of endogenous LH concentrations with GnRH agonists or antagonists-an integral part of standard IVF/ ICSI protocols-may also play a pivotal role. Assisted reproduction technology protocols using GnRH agonists have been considered as the standard protocol during the last two decades, but the use of GnRH antagonists offers the opportunity to control the endogenous LH surge in a rapid and more convenient way. LH plays a key role in the intermediate-late phases of folliculogenesis. The presence of receptors for LH in cumulus granulosa cells and its correlation with oocyte maturation has been demonstrated. Although ovarian stimulation is efficiently achieved in most cases by the administration of exogenous FSH alone, specific subgroups of women may benefit from LH activity supplementation during ovarian stimulation. Some authors have found improved outcome with LH activity supplementation in advanced reproductive age women. LH has a number of roles in follicular development, induction of ovulation, completion of meiosis I, early luteinization and the production of progesterone. The efficacy of recombinant human follicle-stimulating hormone (r-hFSH) for ovarian stimulation is well established however, the role of supplementary recombinant human luteinizing hormone (r-hLH) is less clear. Aim of the present study is to evaluate If adding rLH in the late phase of stimulation can benefit in some patient awith repeated implantation failure.

Conditions

Female Infertility; Female Subfertility

Outcome Measures

Primary Outcomes (1)

• Number of ovocites retrived

  Possible beneficial effects of rLH in the late phase of stimulation in patient with repeated implantation failure

  1 cicle of stimulation of 14 days

Study Arms (2)

rFSH + r-LH in combination

EXPERIMENTAL

treatment group

Drug: rFSH + r-LH in combination

rFSH alone

ACTIVE COMPARATOR

control group

Drug: rFSH alone

Interventions

rFSH + r-LH in combination DRUG

29 women stimulated with rFSH supplemented by rLH in the late follicular phase started at the same time of starting the antagonist administration.

rFSH + r-LH in combination

rFSH alone DRUG

32 women who were stimulated with recombinant FSH alone

rFSH alone

Eligibility Criteria

• Age: 18 Years - 42 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Only patients with repeated implantation failure in at least two previous IVF cycles were included.

You may not qualify if:

• Patients were excluded from the study if they had any clinically significant systemic disease, polycystic ovarian syndrome (PCOS), a previous history of severe ovarian hyperstimulation syndrome (OHSS), abnormal gynaecological bleeding of unknown origin, a previous history of intolerance to any of the agents used in the study.

Sponsors & Collaborators

• University of Roma La Sapienza: lead

MeSH Terms

Conditions

Infertility, Female

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Infertility

Study Officials

• Davide Francomano

  University of Roma La Sapienza

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PHD

Study Record Dates

• First Submitted: December 9, 2016
• First Posted: June 29, 2017
• Study Start: January 1, 2016
• Primary Completion: September 1, 2016
• Study Completion: September 1, 2016
• Last Updated: June 29, 2017

Record last verified: 2017-06

Data Sharing

• IPD Sharing: Will not share