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Ovulation InductionPhase 2NCT00553514

AS900672-Enriched in Ovulation Induction

A Phase 2 study testing AS900672-Enriched 10 microgram (mcg), AS900672-Enriched 20 mcg and AS900672-Enriched 30 mcg in people with Ovulation Induction, run by Merck KGaA, Darmstadt, Germany at 1 site in Switzerland.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

This is a Phase 2, interventional, multi-center, randomized, assessor-blind, active-comparator, dose-finding study to evaluate a new investigational long-acting follicle stimulating hormone (FSH) in oligo-anovulatory women undergoing ovulation induction (OI). Read more about this study

Who is it for?
Ages 18 to 36 years, women only
Conditions the study is for
Ovulation Induction
What is being tested?
AS900672-Enriched 10 microgram (mcg), AS900672-Enriched 20 mcg and AS900672-Enriched 30 mcg
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
71 participants
Where
1 siteSwitzerland
Study dates
Dec 2007to Mar 2009
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 18 to 36 years
  • Women only
  • No healthy volunteers
  • Adult

Who may be able to join

  • Oligo-anovulation defined by a menstrual period of 35 days to 6 months
  • Spontaneous menses or a positive response to progestin within the prior 6 months or response to clomiphene citrate evidenced by ovulation within the prior 6 months
  • Age between 18 and 36 years, inclusive, at time of informed consent signature
  • Body mass index (BMI) 18 to 30 kilogram per square meter (kg/m^2), inclusive
  • No clinically significant abnormalities in serum thyroid stimulating hormone (TSH), dehydroepiandrosterone (DHEA-S), prolactin, and FSH levels in the early follicular phase. Subjects low TSH level who receive replacement therapy could be enrolled at the discretion of the investigator if local laboratory results (thyroxine [T4]) demonstrated satisfactory thyroid function. Subjects receiving stable dose of dopamine agonists could be enrolled at the discretion of the investigator if local laboratory results demonstrated adequate control of prolactin levels
  • No clinically significant abnormalities in fasting glucose and fasting insulin levels
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  • Normal uterine cavity and presence of at least one ovary with ipsilateral patent fallopian tube, as determined by means of hysterosalpingography, laparoscopy, hysteroscopy or combination of these procedures within the prior 3 years
  • Papanicolaou (PAP) smear test without clinically significant abnormalities within 6 months prior to the first screening procedure. If PAP smear is not done, it must be performed as part of screening procedures
  • Negative pregnancy test prior to randomization
  • Male partner with semen analysis demonstrating adequacy for insemination via intercourse and/or intrauterine insemination (IUI) within 6 months prior to the first screening procedure. If semen analysis is not done, it must be performed as part of screening procedures
  • Willing and able to comply with all protocol procedures, including pregnancy and neonatal follow-up
  • Voluntary provision of written informed consent, prior to any trial-related procedure that is not part of normal medical care, with the understanding that the subject could withdraw consent at any time without prejudice to her future medical care, including willingness to provide follow-up information on babies born as part of this trial

Who cannot join

  • History of >=2 consecutive gonadotrophin stimulation cycles that did not lead to ovulation
  • History of clomiphene citrate stimulation cycles of which none lead to ovulation
  • Prior excessive response to gonadotrophin stimulation, defined as the development of at least 4 mature follicles (greater than [>]17 mm) or cancellation of the OI cycle due to excessive follicular response after treatment with FSH at a dose of less than 75 IU/day
  • Previous severe ovarian hyperstimulation syndrome (OHSS)
  • Administration of any gonadotrophin, clomiphene citrate, gonadotrophin releasing hormone (GnRH) analogue, tamoxifen or aromatase inhibitors within the prior 30 days
  • Laparoscopic ovarian drilling and/or ovarian cauterization within the prior 6 months
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  • Any contraindication to pregnancy and/or to carrying pregnancy to term
  • A clinical pregnancy that ended in a miscarriage within the prior 3 months
  • History of >=3 consecutive miscarriages, due to any cause
  • Abnormal gynecological bleeding of undetermined origin
  • Clinically significant abnormal findings of the uterine cavity evident on a transvaginal pelvic ultrasound performed during screening
  • Presence of endometriosis, Grade III - IV or requiring treatment
  • Ovarian cyst with a mean diameter of >25 mm on the day of randomization
  • History or suspicion of ovarian, uterine or mammary cancer
  • Adrenal congenital hyperplasia, partial or complete enzymatic block
  • Use of metformin or other insulin sensitizing agents related to infertility within the prior 2 months
  • Known allergy or hypersensitivity to human gonadotrophin preparations or to compounds that are structurally similar to any of the other medications administered during the trial
  • Any contra-indication to gonadotrophin therapy
  • Known or suspected infection with human immunodeficiency virus (HIV), Hepatitis B or C in the trial subject or her male partner
  • Any active substance abuse or history of drug, medication or alcohol abuse within 5 years
  • Smoker consuming more than 5 cigarettes per day
  • Serum testosterone (central laboratory) that is suggestive of ovarian tumor
  • Previously randomized in this trial or participation in another investigational drug clinical trial within the prior 3 months
  • Any medical condition, which in the judgment of the investigator may interfere with the absorption, distribution, metabolism or excretion of r-hFSH
  • Clinically significant concurrent disease (including diabetes mellitus and autoimmune diseases) that would compromise subject safety or interfere with the study assessments or clinically significant abnormal laboratory finding

Trial locations and contacts

1 site in 1 country.

Switzerland1 site

  • Merck Serono S.A.

    Geneva, 1202

Other trials in Switzerland

About this study

Official title: A Phase II, Multicentre, Randomised, Assessor-blinded, Active-comparator, Parallel-group Dose Finding Trial to Evaluate AS900672-enriched Versus Follitropin Alfa (GONAL-f®) in Oligo-anovulatory Infertile Women Undergoing Ovulation Induction (OI)

This is a Phase 2, interventional, multi-center, randomized, assessor-blind, active-comparator, dose-finding study to evaluate a new investigational long-acting follicle stimulating hormone (FSH) in oligo-anovulatory women undergoing ovulation induction (OI). This study will compare 4 doses of the investigational drug versus a currently marketed drug follitropin alfa (Gonal-f ®) prefilled pen with regards to ovulation rate.

Read the detailed description

The study was terminated after Merck Serono had taken the decision not to pursue the development of AS900672-enriched in ovulation induction (OI). This decision was not related to any safety or efficacy concerns over the use of AS900672-Enriched in OI.

Being tested
AS900672-Enriched 10 microgram (mcg), AS900672-Enriched 20 mcg, AS900672-Enriched 30 mcg, AS900672-Enriched 40 mcg, Follitropin alfa 75 international unit (IU)
Keywords
Infertility, Oligo-anovulation, GONAL-f®, AS900672-Enriched, hyperglycosylated recombinant human follicle stimulating hormone (r-hFSH)
Medical subject headings
Infertility

What participants receive

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

  • AS900672-Enriched 10 microgram (mcg)Drug

    Also called Hyperglycosylated r-hFSH

    Single injection of AS900672-Enriched (hyperglycosylated recombinant human follicle stimulating hormone [r-hFSH]), 10 mcg will be administered subcutaneously on Stimulation Day 1 (S1). Duration of treatment cycle will be up to adequate follicular response received or maximum of 14 days.

  • AS900672-Enriched 20 mcgDrug

    Also called Hyperglycosylated r-hFSH

    Single injection of AS900672-Enriched (hyperglycosylated r-hFSH), 20 mcg will be administered subcutaneously on S1. Duration of treatment cycle will be up to adequate follicular response received or maximum of 14 days.

  • AS900672-Enriched 30 mcgDrug

    Also called Hyperglycosylated r-hFSH

    Single injection of AS900672-Enriched (hyperglycosylated r-hFSH), 30 mcg will be administered subcutaneously on S1. Duration of treatment cycle will be up to adequate follicular response received or maximum of 14 days.

  • AS900672-Enriched 40 mcgDrug

    Also called Hyperglycosylated r-hFSH

    Single injection of AS900672-Enriched (hyperglycosylated r-hFSH), 40 mcg will be administered subcutaneously on S1. Duration of treatment cycle will be up to adequate follicular response received or maximum of 14 days.

  • Follitropin alfa 75 international unit (IU)Drug

    Also called Gonal-f®, Follicle stimulating hormone (FSH)

    Follitropin alfa (Gonal-f®) 75 IU will be administered subcutaneously once daily from S1 up to Stimulation Day 14 (S14) based upon ovarian response, until recombinant human chorionic gonadotropin (r-hCG) administration day. Subjects who will be receiving AS900672-Enriched 10, 20, 30 and 40 mcg will also receive daily dose of follitropin alfa 75 IU subcutaneously from Stimulation Day 7 (S7) up to S14. Duration of treatment cycle will be up to adequate follicular response received or maximum of 14 days.

  • Recombinant human chorionic gonadotropin (r-hCG)Drug

    Recombinant human chorionic gonadotropin (r-hCG) will be administered as a single dose of 250 mcg subcutaneously, when follicular response is adequate (that is, less than or equal to [=<] 3 follicles with a mean diameter of greater than or equal to [>=] 14 millimeter [mm], and one or two of these follicles with a diameter of >= 17 mm).

Study groups in NCT00553514
Study groupRoleWhat they receive
AS900672-Enriched 10 mcgExperimentalNot described
Receives: Drug: AS900672-Enriched 10 microgram (mcg); Drug: Follitropin alfa 75 international unit (IU); Drug: Recombinant human chorionic gonadotropin (r-hCG)
AS900672-Enriched 20 mcgExperimentalNot described
Receives: Drug: AS900672-Enriched 20 mcg; Drug: Follitropin alfa 75 international unit (IU); Drug: Recombinant human chorionic gonadotropin (r-hCG)
AS900672-Enriched 30 mcgExperimentalNot described
Receives: Drug: AS900672-Enriched 30 mcg; Drug: Follitropin alfa 75 international unit (IU); Drug: Recombinant human chorionic gonadotropin (r-hCG)
AS900672-Enriched 40 mcgExperimentalNot described
Receives: Drug: AS900672-Enriched 40 mcg; Drug: Follitropin alfa 75 international unit (IU); Drug: Recombinant human chorionic gonadotropin (r-hCG)
Follitropin alfa 75 IUActive comparatorNot described
Receives: Drug: Follitropin alfa 75 international unit (IU); Drug: Recombinant human chorionic gonadotropin (r-hCG)

What is being measured

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

  1. Percentage of Participants With Ovulation

    Ovulation was defined as a mid-luteal phase progesterone (P4) level >= 30 nanomole per liter (nmol/L) (10 nanogram per milliliter [ng/mL]). In the absence of a positive progesterone response, clinical pregnancy was also considered as evidence of ovulation.

    Measured: Mid-luteal phase progesterone assessed 5-10 days or clinical pregnancy 35-42 days after recombinant human chorionic gonadotropin (r-hCG) administration day (end of stimulation cycle [approximately 14 days])

Secondary outcomes (5)

  1. Percentage of Participants With Clinical Pregnancy

    Clinical pregnancy was defined as the presence of one or more fetal sacs with fetal heart activity on the Day 35-42 post r-hCG ultrasound examination.

    Measured: Day 35-42 post r-hCG administration day (end of stimulation cycle [approximately 14 days])

  2. Duration of Ovarian Stimulation

    Ovarian stimulation included from first dose of study drug on S1 until day on which r-hCG was administered (r-hCG day).

    Measured: Stimulation Day 1 (S1) up to r-hCG administration day (end of stimulation cycle [approximately 14 days])

  3. Duration of Supplemental Follitropin Alfa Treatment

    Measured: Stimulation Day 7 (S7) up to r-hCG administration day (end of stimulation cycle [approximately 14 days])

  4. Cumulative Dose of Supplemental Follitropin Alfa Administered

    Measured: Stimulation Day 7 (S7) up to r-hCG administration day (end of stimulation cycle [approximately 14 days])

  5. Number of Follicles With Mean Diameter Less Than (<) 11 Millimeter (mm) and Greater Than or Equal to (>=) 11 mm

    Measured: Stimulation Day 5 (S5), S7 and r-hCG administration day (end of stimulation cycle [approximately 14 days])

Timeline

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

  1. First posted5 Nov 2007 (estimated)
  2. Study startDec 2007
  3. Primary completionMar 2009
  4. Study completionMar 2009

Why it stopped: The study was terminated after Merck Serono had taken the decision not to pursue the development of AS900672-enriched in ovulation induction

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
Single blind
Who is masked
Outcomes assessor
Enrolment
71 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00553514
Sponsor's protocol ID
27818
Status last verified
Jan 2014
First submitted
1 Nov 2007
Last updated
13 Feb 2014

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing AS900672-Enriched 10 microgram (mcg), AS900672-Enriched 20 mcg and AS900672-Enriched 30 mcg in people with Ovulation Induction, run by Merck KGaA, Darmstadt, Germany at 1 site in Switzerland.

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 12 inclusion and 25 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: stopped early, as of the sponsor's last update on 13 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 Switzerland. 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 25 Jul 2013). 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?

Percentage of Participants With Ovulation (time frame: Mid-luteal phase progesterone assessed 5-10 days or clinical pregnancy 35-42 days after recombinant human chorionic gonadotropin (r-hCG) administration day (end of stimulation cycle [approximately 14 days])). 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 NCT00553514.

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 13 Feb 2014.

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