A Randomised, Phase II, Comparative Study With a Parallel Control for Evaluating the Efficacy and Safety of Combined Treatment of Lutropin Alpha and Recombinant Human Luteinizing Hormone in the Middle of the Controlled Ovarian Stimulation Follicular Phase in Women With Reduced Ovarian Reserve

NCT01110707 | Completed Phase 2 Results

• 1 other identifier: IMP 25186
• Study Type: interventional
• Target: 131
• Locations: 1 country
• Sites: 1

Brief Summary

This was a prospective, randomized, Phase II, comparative study with a parallel control for evaluating the efficacy and safety of combined treatment of recombinant human follicle stimulating hormone (r-hFSH) and recombinant human luteinizing hormone (r-hLH). The combined treatment was administered at the middle of the follicular phase in subjects undergoing in-vitro fertilisation (IVF) through intracytoplasmic sperm injection (ICSI) and transfer of embryos (ET).

Conditions

Infertility; Ovulation Induction

Keywords

Reproductive technology, Assisted; Recombinant human follicle stimulating hormone (r-hFSH); Recombinant leutinizing hormone (r-hLH); Ovulation induction; Infertility

Outcome Measures

Primary Outcomes (1)

• Mean Number of Metaphase II (M-II) Oocytes Retrieved

  Mean number of M-II oocytes were calculated for subjects undergoing ovum pick up for Intra-cytoplasmic Sperm Injection (ICSI). ICSI is an in-vitro fertilization procedure in which a single sperm is injected directly into an egg under a microscope. Metaphase II stage of the oocyte was classified as the time at which the first polar body was observed microscopically. Metaphase II oocytes are a sub-group of the total number of oocytes.

  36 hours post r-hCG administration

Secondary Outcomes (8)

• Number of Fertilized Oocytes (2 Pronuclei [2PN])

  36 hours post r-hCG administration

• Quality of Embryos

  Day 2-3 post r-hCG administration

• Embryo Implantation Rate

  35-42 days post r-hCG administration

• Clinical Pregnancy Rate

  35-42 days post r-hCG administration

• Mean Number of Follicles Greater Than or Equal to (>=) 14 Millimeter (mm)

  r-hCG day (end of stimulation cycle [approximately 28 days])

Study Arms (2)

r-hFSH + r-hLH

EXPERIMENTAL

Drug: Recombinant human follicle stimulating hormone (r-hFSH); Drug: Recombinant human luteinizing hormone (r-hLH)

r-hFSH alone

ACTIVE COMPARATOR

Drug: Recombinant human luteinizing hormone (r-hLH)

Interventions

Recombinant human follicle stimulating hormone (r-hFSH) DRUG

Subjects will receive subcutaneous injection of recombinant human follicular stimulating hormone (r-hFSH) 300-450 International Units (IU) administered after pituitary desensitization according to the ovarian response with gonadotrophin-releasing hormone agonist (GnRH-a; at a dose of 0.1 milligram per day \[mg/day\]).

Also known as: GONAL-f, Follitrophin alpha

r-hFSH + r-hLH

Recombinant human luteinizing hormone (r-hLH) DRUG

Subjects will receive subcutaneous injection of recombinant human luteinizing hormone (r-hLH) 150 IU/day until the end of ovarian stimulation.

Also known as: Luveris, Lutrophin alpha

r-hFSH + r-hLH; r-hFSH alone

Eligibility Criteria

• Age: 35 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Postmenopausal woman aged between 35 and 40 years that wishes to become pregnant
• Subjects with basal serum level (beginning of the follicular phase, Day 2-5) of Follicle-Stimulating Hormone (FSH) less than 10 IU/L determined within the 6 months prior as well as Luteinizing hormone (LH) and Estradiol (E2) levels within the normal interval according to standard data for the area where the study was carried out
• Subjects with a regular menstrual cycles between 25-35 days
• Subjects with infertility that justifies treatment with IVF/ET or ICSI
• Subjects undergoing controlled ovarian stimulation (COS) with r-hFSH using a long protocol with GnRH-a
• Sperm availability from the subject's current partner unless it is planned to use sperm from a donor
• Subjects with both ovaries
• Subjects with uterine cavity capable of withstanding the implantation of the embryo and pregnancy
• Subjects whose vaginal smear (PAP) was normal within the 3 years prior to starting the stimulation
• Subjects with body mass index (BMI) between 18 and 30 at the time of participation in the study
• Subjects in whom at least 30 days have elapsed since the last dose of clomiphene citrate or gonadotropins before beginning treatment with GnRH-a
• Subjects with a negative pregnancy test result using the beta human chorionic gonadotropin (beta-hCG) test (in urine or blood) before beginning treatment with GnRH-a
• Subjects willing to and capable of following the protocol during the entire study
• Subjects who have provided informed written consent before carrying out any procedure related with the study (that is not part of the normal medical treatment followed by the subject)

You may not qualify if:

• Subject who were human immunodeficiency virus, hepatitis B and C virus positive
• Subjects suffering from any clinically important systematic disease, hypothalmic or pituitary tumour, ovarian, uterine or breast cancer, endocrinopathy and/or medical alterations, biochemical or hematological that as per the investigators judgement, may interfere with the gonadotropin treatment
• Subjects who have been subjected to more than 2 assisted reproductive cycles in the past
• Subjects who have cancelled 2 cycles in the past
• Subjects who have cryopreserved embryos from previous assisted reproductive cycles
• Subjects with non explained vaginal haemorrhages
• Subjects with polycystic ovary, enlarged ovary or ovarian cysts of unknown aetiology
• Subjects with any contraindication for getting pregnant or taking the pregnancy to full term
• Subjects with known allergy to the gonadotropin preparations or any of its excipients
• Subjects with current drug use or prior personal history of alcohol, drug or psychiatric drug dependency in the past five years
• Subjects with prior participation in this study or simultaneous participation in a different clinical study with a medication under investigation
• Subjects who were not willing to or incapable of following the study protocol

Sponsors & Collaborators

• Merck KGaA, Darmstadt, Germany: lead

Study Sites (1)

Hospital de Cruces, Plaza de Cruces, 12, 48903

Vizcaya, Spain

Location

Related Publications (2)

• Matorras R, Prieto B, Exposito A, Mendoza R, Crisol L, Herranz P, Burgues S. Mid-follicular LH supplementation in women aged 35-39 years undergoing ICSI cycles: a randomized controlled study. Reprod Biomed Online. 2009 Dec;19(6):879-87. doi: 10.1016/j.rbmo.2009.09.016.

  PMID: 20031032 RESULT

• Matorras R, Prieto B, Exposito A, Mendoza R, Crisol L, Herranz P, Burgues S. Mid-follicular LH supplementation in women aged 35-39 years undergoing ICSI cycles: a randomized controlled study. Reprod Biomed Online. 2011 Feb;22 Suppl 1:S43-51. doi: 10.1016/S1472-6483(11)60008-4.

  PMID: 21575849 RESULT

MeSH Terms

Conditions

Infertility; Helping Behavior

Interventions

Glycoprotein Hormones, alpha Subunit; follitropin alfa; Luteinizing Hormone, beta Subunit

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases; Social Behavior; Behavior

Intervention Hierarchy (Ancestors)

Chorionic Gonadotropin; Gonadotropins; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Follicle Stimulating Hormone; Gonadotropins, Pituitary; Luteinizing Hormone; Pituitary Hormones, Anterior; Pituitary Hormones; Thyrotropin; Placental Hormones; Peptides; Amino Acids, Peptides, and Proteins

Results Point of Contact

• Title: Merck KGaA Communication Center
• Organization: Merck Healthcare, a business of Merck KGaA, Darmstadt, Germany

service@merckgroup.com

+49-6151-72-5200

Study Officials

• Medical Responsible

  Merck KGaA, Darmstadt, Germany

  STUDY DIRECTOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 22, 2010
• First Posted: April 27, 2010
• Study Start: January 10, 2005
• Primary Completion: November 15, 2006
• Study Completion: November 15, 2006
• Last Updated: March 27, 2018
• Results First Posted: March 27, 2018

Record last verified: 2017-08

Locations

ES (1)