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InfertilityPhase 2NCT01110707

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

A Phase 2 study testing Recombinant human follicle stimulating hormone (r-hFSH) and Recombinant human luteinizing hormone (r-hLH) in people with Infertility and Ovulation Induction, run by Merck KGaA, Darmstadt, Germany at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 35 to 40 years, women only
Conditions the study is for
Infertility, Ovulation Induction
What is being tested?
Recombinant human follicle stimulating hormone (r-hFSH) and Recombinant human luteinizing hormone (r-hLH)
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
131 participants
Where
1 siteSpain
Study dates
10 Jan 2005to 15 Nov 2006
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 35 to 40 years
  • Women only
  • No healthy volunteers
  • Adult

Who may be able to join

  • All subjects must meet the following inclusion criteria within the 6 months prior to starting the pituitary suppression unless otherwise specified:
  • 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
Show all 15Show fewer
  • 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)

Who cannot join

  • 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
Show all 12Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

Spain1 site

  • Hospital de Cruces, Plaza de Cruces, 12, 48903

    Vizcaya

Other trials in Spain

About this study

Official title: Lutropin Alpha in the Middle of the Controlled Ovarian Stimulation Follicular Phase in Women With Reduced Ovarian Reserve: Comparative Study, in Phase II, With Parallel Control

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).

Being tested
Recombinant human follicle stimulating hormone (r-hFSH), Recombinant human luteinizing hormone (r-hLH)
Keywords
Reproductive technology, Assisted, Recombinant human follicle stimulating hormone (r-hFSH), Recombinant leutinizing hormone (r-hLH), Ovulation induction, Infertility
Medical subject headings
Infertility, Helping Behavior

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Recombinant human follicle stimulating hormone (r-hFSH)Drug

    Also called GONAL-f, Follitrophin alpha

    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]).

  • Recombinant human luteinizing hormone (r-hLH)Drug

    Also called Luveris, Lutrophin alpha

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

Study groups in NCT01110707
Study groupRoleWhat they receive
r-hFSH + r-hLHExperimentalNot described
Receives: Drug: Recombinant human follicle stimulating hormone (r-hFSH); Drug: Recombinant human luteinizing hormone (r-hLH)
r-hFSH aloneActive comparatorNot described
Receives: Drug: Recombinant human luteinizing hormone (r-hLH)

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 36 hours post r-hCG administration

Secondary outcomes (8)

  1. Number of Fertilized Oocytes (2 Pronuclei [2PN])

    Oocytes were fertilized using Intra-cytoplasmic Sperm Injection (ICSI) technique which is an in-vitro fertilization procedure in which a single sperm is injected directly into an egg under a microscope. The appearance of 2PN is the first sign of successful fertilization as observed during in vitro fertilization, and is usually observed after ICSI. The zygote is then termed 2PN.

    Measured: 36 hours post r-hCG administration

  2. Quality of Embryos

    Embryos were classified into 5 different grades (1 to 5) based on their capacity of implantation. Grade 1 embryos were those with best capacity of implantation and Grade 5 embryos were those with worst capacity of implantation. Mean number of embryos for each of the 5 grades were reported.

    Measured: Day 2-3 post r-hCG administration

  3. Embryo Implantation Rate

    Embryo implantation rate was measured as the number of gestational sacs observed divided by the number of embryos transferred multiplied by 100.

    Measured: 35-42 days post r-hCG administration

  4. Clinical Pregnancy Rate

    Clinical pregnancy rate defined as the percentage of subjects with a ultrasound confirmation of a gestational sac, with or without fetal heart activity.

    Measured: 35-42 days post r-hCG administration

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

    Mean number of follicles as per the following categories were presented: >=14 mm and less than (<) 16 mm; >=16 mm and <18 mm and >=18 mm.

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

  6. Endometrial Thickness

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

  7. Number of Cycles Cancelled Due to Unsatisfactory Response

    If the subject was not administered with r-hCG and withdrew prematurely from the trail, it is considered as cycle cancellation

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

  8. Mean Number of Oocytes Retrieved

    Oocyte retrieval is a technique used in in-vitro fertilization (IVF) in order to remove oocyte from the ovary of the female subject, enabling fertilization outside the body.

    Measured: 36 hours post r-hCG administration

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Apr 2010 (estimated)
  2. Study start10 Jan 2005
  3. Primary completion15 Nov 2006
  4. Study completion15 Nov 2006

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
131 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01110707
Sponsor's protocol ID
IMP 25186
Status last verified
Aug 2017
First submitted
22 Apr 2010
Last updated
27 Mar 2018

Publications

  • 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.

    PubMed 20031032

  • 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.

    PubMed 21575849

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Recombinant human follicle stimulating hormone (r-hFSH) and Recombinant human luteinizing hormone (r-hLH) in people with Infertility and Ovulation Induction, run by Merck KGaA, Darmstadt, Germany at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 15 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 27 Mar 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mean Number of Metaphase II (M-II) Oocytes Retrieved (time frame: 36 hours post r-hCG administration). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01110707, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2018.

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