Study to Evaluate if the Addition of r-hLH (Luveris®) to FSH From Day 8 of Ovarian Stimulation is Able to Decrease Total FSH Dose and to Improve Cycle Outcome in Infertile Women Undergoing ART, Who Required High FSH Dose in a Previous Cycle

NCT01071200 | Terminated Phase 3 Results

• 2 other identifiers: IMP252892004-002218-13
• Study Type: interventional
• Target: 133
• Locations: 1 country
• Sites: 1

Brief Summary

The present study was designed to investigate, in hyporesponder subjects, that required in a previous assisted reproductive technologies (ART) cycle follicle stimulating hormone (FSH) \>3500 International Unit (IU), the possibility to decrease through recombinant human luteinizing hormone (r-hLH) supplementation, the FSH amount per oocytes retrieved and in the mean time to improve the overall cycle outcome.

Conditions

Reproductive Techniques, Assisted

Keywords

Reproductive Techniques, Assisted; Recombinant human follicle stimulating hormone (r-hFSH); Recombinant leutinizing hormone (r-hLH)

Outcome Measures

Primary Outcomes (1)

• Total Dose of Follicular Stimulating Hormone (FSH) for Retrieved Oocytes

  Baseline (Stimulation day 8 [S8]) until hCG day

Secondary Outcomes (13)

• Mean Total Follicle Stimulating Hormone (FSH) and Recombinant Human Luteinizing Hormone (r-hLH) Dose

  Baseline (S8) until hCG day

• Mean Number of Ovarian Stimulation Days

  Baseline (S8) until hCG day

• Change From Baseline in Oestradiol (E2) Levels at Human Choriogonadotropin (hCG) Day

  Baseline (S8) and hCG day

• Mean Total Number of Retrieved Oocytes

  34-36 hours post-hCG (OPU)

• Mean Number of Mature Oocytes (Metaphase II)

  34-36 hours post-hCG (OPU)

Study Arms (2)

A

EXPERIMENTAL

Subjects treated with r-hFSH and r-hLH (2:1 ratio of r-hFSH:r-hLH)

Drug: Recombinant human Follicle Stimulating Hormone (r-hFSH) and Recombinant human Luteinizing Hormone (r-hLH)

B

ACTIVE COMPARATOR

Subjects treated with r-hFSH alone

Drug: r-hFSH

Interventions

Recombinant human Follicle Stimulating Hormone (r-hFSH) and Recombinant human Luteinizing Hormone (r-hLH) DRUG

One r-hFSH and one r-hLH injection subcutaneously (s.c.) once daily during the treatment phase from Day 8 of stimulation until injection of human chorionic gonadotropin (hCG) or cancellation of the treatment cycle.

Also known as: r-hLH, r-hFSH

A

r-hFSH DRUG

One r-hFSH injection s.c. once daily during the treatment phase from Day 8 of stimulation until injection of hCG or cancellation of the treatment cycle.

B

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Pre-menopausal infertile woman, aged 18 to 40 years inclusive, who wishes to conceive
• Regular, spontaneous menstrual cycle of 25-35 days
• Body mass index (BMI) ≤ 28
• FSH ≤ 10 IU/L (follicular phase, days 2-5)
• Prolactin (PRL) within the normal ranges
• Evidence of both ovaries by ultrasound scan
• Women undergoing IVF-Embryo Transfer (ET) or ICSI, down regulated with Gonadotropin releasing hormone analogues (GnRHa) (daily dose) under controlled ovarian hyperstimulation (COH) with FSH
• Washout \> 90 days from last dose of clomiphene or gonadotrophin, before ongoing COH cycle
• Only one previous IVF-ET or ICSI cycle (in the last 9 months preceding the ongoing COH cycle) resulted in a hypo-response properly documented (from 6 to 12 oocytes with a total FSH dose ≥ 4000 IU)
• Negative pregnancy hCG test (urine or blood sample) before the ongoing COH cycles
• Willing and able to comply with the protocol for the duration of the study
• Written informed consent before applying any procedure related to the study protocol, which is not part of routine medical care, with the understanding that consent may be withdrawn by the subject at any time, without prejudice on their future medical care

You may not qualify if:

• Oligo/Anovulatory cycles (World Health Organization \[WHO\] I and II)
• Male partner azoospermia (assessed within the last 12 months)
• Follicular phase (day 2-5) FSH \> 10 IU/L even if only once observed in the medical history
• Abnormal cervical cytology (assessed within the last 12 months)
• History of unexplained gynecologic hemorrhage
• Any contraindication to pregnancy
• Known allergy to gonadotrophin
• Any clinically important systemic disease (e.g. insulin-dependent diabetes mellitus, epilepsy, serious migraine, intermittent purpura, hepatic, renal or cardiovascular disease, serious corticoid-dependent asthma) which constitutes a contraindication to gonadotropin use
• Known Human Immunodeficiency Virus (HIV) positivity
• Any substance abuse or history of drugs or alcohol abuse within the past 5 years
• Refusal or inability to comply with the protocol

Sponsors & Collaborators

• Merck KGaA, Darmstadt, Germany: lead
• Merck Serono S.P.A., Italy: collaborator

Study Sites (1)

Merck Serono S.p.A.

Roma, Italy

Location

MeSH Terms

Conditions

Helping Behavior

Condition Hierarchy (Ancestors)

Social Behavior; Behavior

Results Point of Contact

• Title: Merck KGaA Communication Center
• Organization: Merck Serono, a division of Merck KGaA

service@merckgroup.com

+49-6151-72-5200

Study Officials

• Salvatore Longobardi

  Merck Serono S.P.A., Italy

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 18, 2010
• First Posted: February 19, 2010
• Study Start: March 1, 2005
• Primary Completion: April 1, 2009
• Study Completion: April 1, 2009
• Last Updated: December 27, 2013
• Results First Posted: August 14, 2012

Record last verified: 2013-12

Locations

IT (1)