utropin alfa (Luveris) in mid follicular phase for controlled ovarian stimulation (COS) in ovarian ageing: a randomised, comparative with parallel control group, phase II clinical trial. - Lutropin alfa in mid follicular phase

Phase 1

• Conditions: Controlled ovarian stimulation in women with ovarian ageingPT: Assisted Fertilisation; MedDRA version: 7.0Level: PTClassification code 10003539

• Registration Number: EUCTR2004-001503-36-ES
• Lead Sponsor: SERONO ESPAÑA, S.A.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2004-10-14
• Study Completion: 2006-11-15
• Last Update Posted: 19 April 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: 0

Inclusion Criteria

1)Pre-menopausal woman, aged between 35 and 40 years of age inclusive, wishing to conceive.
2)Baseline (early follicular, day 2-5) FSH serum level £ 10 IU/l assessed within the past 6 months as well as LH and E2 levels within local normal range.
3)Having regular spontaneous menstrual cycle lasting 25-35 days.
4)Infertility justifying IVF/ET or ICSI treatment.
5)Controlled ovarian stimulation with r-hFSH under long GnRH agonist protocol.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1)Known to be HIV, HBV/HCV positive.
2)Any clinically significant systemic disease; tumours of the hypothalamus and pituitary gland; ovarian, uterine or mammary cancer; hormonal abnormality and/or medical, biochemical, hematological condition which in the judgement of the investigator may interfere with gonadotropin treatment.
3)More than 2 previous ART cycles
4)Cancellation of two previous cycles.
5)Cryopreserved embryos from previous ART cycles

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To assess the efficacy of mid-follicular addition of r-hLH versus no addition of r-hLH, in patients aged between 35 and 40 undergoing controlled ovarian stimulation with r-hFSH priot to IVF / ICSI and ET, in terms of oocyte quality as well as follicular development, oocyte fertilization, embryo quality and pregnancy rates.;Secondary Objective: To assess the safety of using r-hLH in combination with r-hFSH in this indication, including incidence of ovarian hyperstimulation syndrome (OHSS) and adverse events as well as local tolerance;Primary end point(s): The proportion of metaphase II oocytes retrieved