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InfertilityPhase 2NCT01735422

A Study to Evaluate Safety and Efficacy of Recombinant Human Luteinizing Hormone (r-hLH) Compared With Urinary Human Chorionic Gonadotrophin (u-hCG) to Trigger Ovulation in Infertile Women

A Phase 2 study testing r-hFSH, r-hLH and u-hCG in people with Infertility, run by Merck KGaA, Darmstadt, Germany at 1 site in Canada.

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 is a single center, open-label, randomized, parallel group, dose finding study to evaluate safety and efficacy of recombinant human luteinizing hormone (r-hLH, LHadi®), compared with urinary human chorionic gonadotrophin (u-hCG, Profasi®), both given subcutaneously, in inducing ovulation in infertile women… Read more about this study

Who is it for?
Ages 20 to 40 years, women only
Conditions the study is for
Infertility
What is being tested?
r-hFSH, r-hLH and u-hCG
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
67 participants
Where
1 siteCanada
Study dates
Dec 1999to Jul 2001
Phase
Phase 2
Are there results?
None posted in the registry

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 20 to 40 years
  • Women only
  • No healthy volunteers
  • Adult

Who may be able to join

  • Infertile woman wishing to conceive and justifying ovarian stimulation treatment with gonadotrophins for in vivo conception
  • Aged 20-40 years (inclusive)
  • Male partner with acceptable semen analysis for intra-uterine insemination, according to center's standard practice
  • Have the following hormone serum levels measured locally during early (Day 2-4) follicular phase (if menstruating) or at anytime (if not menstruating):
  • Follicle stimulating hormone (FSH) less than 12 international unit per liter (IU/L)
  • Prolactin (PRL) less than 800 milli international unit per liter (mIU/l)
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  • Lutenizing hormone (LH), P4, Testosterone (T) and Dehydroepiandrosterone sulphate (DHEA-S) for documentation purposes
  • At least one patent tube, as assessed with hysterosalpingography (HSG), ultrasound (U/S) or laparoscopy performed within 3 years prior to beginning r-hFSH treatment
  • Uterine cavity without abnormalities which, in the Investigator's opinion, could impair embryo implantation or pregnancy evolution as assessed with HSG, hysteroscopy (HSC) or U/S performed within 3 years prior to beginning r-hFSH treatment
  • Body mass index (BMI) greater than or equal to 18 and less than or equal to 35 kilogram per square meter (kg/m^2)
  • Negative serum or urinary pregnancy test prior to beginning r-hFSH treatment
  • Be willing and able to comply with the protocol for the duration of the study
  • Have given written informed consent, prior to any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to their future medical care

Who cannot join

  • Any contraindication to being pregnant and/or carrying a pregnancy to term
  • Clinically significant systemic disease (screening for Human Immunodeficiency Virus (HIV) and Hepatitis B and C surface antigens had to be performed to confirm eligibility, unless data obtained within one year prior to beginning r-hFSH treatment was available)
  • Any medical condition which in the judgment of the Investigator's and sponsor may have interfered with the absorption, distribution, metabolism or excretion of the study drug
  • Persistent ovarian cyst with a mean diameter larger than 20 mm or ovarian endometrioma, as assessed with U/S performed prior to beginning r-hFSH treatment
  • Severe endometriosis (American Fertility Society Classification Stage III or IV)
  • World health organization (WHO) Group I anovulation
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  • Pelvic inflammatory disease within 1 year prior to beginning r-hFSH treatment
  • Treatment with clomiphene citrate or gonadotrophins within 1 month prior to beginning r-hFSH treatment
  • Abnormal undiagnosed gynecological bleeding
  • Known allergy or hypersensitivity to human gonadotrophins preparations
  • Known or current substance abuse
  • Previous participation in this study or simultaneous participation in another clinical trial

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • Royal University Hospital

    Saskatoon, Saskatchewan

Other trials in Canada

About this study

Official title: A Phase II, Single Center, Open, Randomized, Parallel Group, Dose Finding Study to Assess the Safety and Efficacy of Recombinant Human Luteinizing Hormone (r-hLH), Compared With Urinary Human Chorionic Gonadotrophin (u-hCG), in Inducing Ovulation in Infertile Women Undergoing Stimulation of Follicular Development With Recombinant Human Follicle Stimulating Hormone (Gonal F®).

This is a single center, open-label, randomized, parallel group, dose finding study to evaluate safety and efficacy of recombinant human luteinizing hormone (r-hLH, LHadi®), compared with urinary human chorionic gonadotrophin (u-hCG, Profasi®), both given subcutaneously, in inducing ovulation in infertile women undergoing stimulation of follicular growth with recombinant human follicle stimulating hormone (r-hFSH, Gonal-F®).

Conditions
Infertility
Being tested
r-hFSH, r-hLH, u-hCG
Keywords
Infertility, Ovulation induction, Recombinant human Luteinizing Hormone (r-hLH), Urinary human Chorionic Gonadotrophin (u-hCG), Recombinant human Follicle Stimulating Hormone (Gonal-f®)
Medical subject headings
Infertility

What participants receive

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

  • r-hFSHDrug

    Also called Gonal-f®

    Daily r-hFSH treatment will be administered subcutaneously at a starting dose according to the site's standard practice from Day 3-5 of menstrual cycle up to follicular development or 28 days. Dose can be altered according to ovarian response (reduced to 75 IU/day; increased to 225 IU/day).

  • r-hLHDrug

    Also called LHadi®

    Ovulation triggering will be performed using a single injection of r-hLH injection subcutaneously at a dose of 825 or 2750 or 5500 or 11,000 or 22,000 IU as soon as follicles satisfy the criteria for follicular development, that is at least 1 follicle with diameter >= 18 mm, not more than 5 follicles with diameter >= 15 mm and with E2 levels less than 9000 picomoles per liter (pmol/L).

  • u-hCGDrug

    Ovulation triggering will be performed using a single injection of 5000 IU of u-hCG as soon as follicles satisfy the criteria for follicular development, that is at least 1 follicle with diameter >= 18 mm, not more than 5 follicles with diameter >= 15 mm and with E2 levels less than 9000 picomoles per liter (pmol/L).

Study groups in NCT01735422
Study groupRoleWhat they receive
r-hLH (825 International Units [IU])ExperimentalNot described
Receives: Drug: r-hFSH; Drug: r-hLH
r-hLH (2750 IU)ExperimentalNot described
Receives: Drug: r-hFSH; Drug: r-hLH
r-hLH (5500 IU)ExperimentalNot described
Receives: Drug: r-hFSH; Drug: r-hLH
r-hLH (11000 IU)ExperimentalNot described
Receives: Drug: r-hFSH; Drug: r-hLH
r-hLH (22000 IU)ExperimentalNot described
Receives: Drug: r-hFSH; Drug: r-hLH
u-hCG (5000 IU)Active comparatorNot described
Receives: Drug: r-hFSH; Drug: u-hCG

What is being measured

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

  1. Ovulation rate

    Measured: Day 4 post r-hLH/u-hCG day (end of stimulation cycle [approximately 28 days])

  2. Ratio of ruptured follicles per follicle with diameter greater than or equal to (>=) 15 millimeter (mm)

    Measured: Day 4 post r-hLH/u-hCG day (end of stimulation cycle [approximately 28 days])

  3. Number of follicles with diameter greater than or equal to (>=) 11 millimeter (mm)

    Measured: Day 4 post r-hLH/u-hCG day (end of stimulation cycle [approximately 28 days])

  4. Ratio of ruptured follicles per follicle with diameter greater than or equal to (>=) 11 millimeter (mm)

    Measured: Day 4 post r-hLH/u-hCG day (end of stimulation cycle [approximately 28 days])

Secondary outcomes (9)

  1. Percentage of participants with mono-follicular ovulation

    Measured: Day 4 post r-hLH/u-hCG day (end of stimulation cycle [approximately 28 days])

  2. Number of participants with biochemical pregnancy

    Measured: Day 25-30 post r-hLH/u-hCG day (end of stimulation cycle [approximately 28 days])

  3. Serum estradiol (E2) levels

    Measured: Day 1, 2 and 6-9 post r-hLH/u-hCG day (end of stimulation cycle [approximately 28 days])

  4. Serum androstenedione levels

    Measured: Day 1, 2 and 6-9 post r-hLH/u-hCG day (end of stimulation cycle [approximately 28 days])

  5. Serum total renin levels

    Measured: Day 1, 2 and 6-9 post r-hLH/u-hCG day (end of stimulation cycle [approximately 28 days])

  6. Serum vascular endothelial growth factor (VEGF) levels

    Measured: Day 1, 2 and 6-9 post r-hLH/u-hCG day (end of stimulation cycle [approximately 28 days])

  7. Endometrial thickness

    Measured: Day 0, 1, 2, 3, 4 and 6-9 post r-hLH/u-hCG day (end of stimulation cycle [approximately 28 days])

  8. Number of participants with clinical pregnancy

    Measured: Day 25-30 post r-hLH/u-hCG day (end of stimulation cycle [approximately 28 days])

  9. Serum progesterone (P4) levels

    Measured: Day 1, 2 and 6-9 post r-hLH/u-hCG day (end of stimulation cycle [approximately 28 days])

Timeline

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

  1. First posted28 Nov 2012 (estimated)
  2. Study startDec 1999
  3. Primary completionJul 2001
  4. Study completionJul 2001

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
67 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01735422
Sponsor's protocol ID
21321
Status last verified
Feb 2014
First submitted
23 Nov 2012
Last updated
4 Feb 2014
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing r-hFSH, r-hLH and u-hCG in people with Infertility, run by Merck KGaA, Darmstadt, Germany at 1 site in Canada.

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 13 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 4 Feb 2014. 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 Canada. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Ovulation rate (time frame: Day 4 post r-hLH/u-hCG day (end of stimulation cycle [approximately 28 days])). The study lists 4 primary outcomes in all. 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 NCT01735422.

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 4 Feb 2014.

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