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Trial · Interventional

CompletedPhase 2Results postedRegistry data

Investigation of a Long-Acting Follicle Stimulating Hormone in Infertile Women Undergoing Assisted Reproductive Technology (ART)

Overview

Status
Completed
Phase
Phase 2
Enrollment
520 participants (actual)
Sponsor
Merck KGaA, Darmstadt, Germany · Industry
Design
Randomized · Single masking
Countries
1 country

United States

Start
Jan 2007
Primary completion
Sept 2008
Completion
Sept 2008
First posted
23 Jul 2007 (estimated)
Last update posted
13 Feb 2014 (estimated)
Conditions
Infertility

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
200720082009
  1. Ph 2

    Investigation of a Long-Acting Follicle Stimulating Hormone in Infertile Women Undergoing Assisted Reproductive Technology (ART)

    NCT00505752

    Jan 2007 to Sept 2008

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

This is a Phase 2, interventional, prospective, multi-center, randomized, assessor-blind, active-comparator, dose-finding study to evaluate a new investigational long-acting follicle stimulating hormone (FSH) in infertile women who are undergoing an assisted reproductive technology (ART) procedure (In vitro fertilization/Intra cytoplasmic sperm injection \[IVF/ICSI\]). This study will compare 3 doses of the investigational drug versus a currently marketed drug follitropin alfa (Gonal-f® revised formulation female \[RFF\] Pen) in regards to the number of fertilized oocytes.

Interventions

  • AS900672-Enriched 50 microgram (mcg)Drug
  • AS900672-Enriched 100 mcgDrug
  • AS900672-Enriched 150 mcgDrug
  • Follitropin alfa 150 international unit (IU)Drug
  • Recombinant human chorionic gonadotropin (r-hCG)Drug

Arms4

  • Experimental

    AS900672-Enriched 50 mcg

  • Experimental

    AS900672-Enriched 100 mcg

  • Experimental

    AS900672-Enriched 150 mcg

  • Active comparator

    Follitropin alfa 150 IU

Primary outcomes1

Outcomes the sponsor listed as primary.

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

    Time frame · Ovum pick-up (OPU) day (34-38 hours post r-hCG administration day [end of stimulation cycle {approximately 21 days}])

    Registry description

    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.

Secondary outcomes(1)
  1. Percentage of Participants With Clinical Pregnancy

    Time frame · Day 35-42 post r-hCG administration day (end of stimulation cycle [approximately 21 days])

    Registry description

    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.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeMean· Ovum pick-up (OPU) day (34-38 hours post r-hCG administration day [end of stimulation cycle {approximately 21 days}])

Number of Fertilized Oocytes (2 Pronuclei [PN])

GroupValue (2PN oocytes)Spread
AS900672-Enriched 50 Mcg7.04.7
AS900672-Enriched 100 Microgram (Mcg)8.74.9
AS900672-Enriched 150 Microgram (Mcg)9.26.0
Follitropin Alfa 150 IU6.74.2
Secondary and other outcome results(1)
Secondary outcomeNumber· Day 35-42 post r-hCG administration day (end of stimulation cycle [approximately 21 days])

Percentage of Participants With Clinical Pregnancy

GroupValue (Percentage of participants)
AS900672-Enriched 50 Mcg39.1
AS900672-Enriched 100 Microgram (Mcg)40.8
AS900672-Enriched 150 Microgram (Mcg)35.2
Follitropin Alfa 150 IU43.8

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
AS900672-Enriched 50 McgSingle injection of AS900672-Enriched (hyperglycosylated recombinant human follicle stimulating hormone \[r-hFSH\]), 50 microgram (mcg) administered subcutaneously on Stimulation day 1 (S1) followed by a daily dose of follitropin alfa 150 international unit (IU) subcutaneously starting from Stimulation Day 6 (S6) up to Stimulation Day 21 (S21) based upon ovarian response, until recombinant human chorionic gonadotropin (r-hCG, Ovidrel®) administration day. When follicular response was adequate (that is, at least 1 follicle with a diameter of greater than or equal to \[\>=\] 18 millimeter \[mm\], two or more additional follicles with a diameter of \>= 16 mm, and Estradiol \[E2\] levels were approximately 150 picogram per milliliter \[pg/mL\] per mature follicle), ovulation was triggered by single 250 mcg subcutaneous r-hCG injection. Duration of treatment cycle was up to adequate follicular response or maximum of 21 days.–5 / 13290 / 132
AS900672-Enriched 100 Microgram (Mcg)Single injection of AS900672-Enriched (hyperglycosylated r-hFSH), 100 mcg administered subcutaneously on S1 followed by a daily dose of follitropin alfa 150 IU subcutaneously starting from S6 up to S21 based upon ovarian response, until r-hCG administration day. When follicular response was adequate (that is, at least 1 follicle with a diameter of \>= 18 mm, two or more additional follicles with a diameter of \>= 16 mm, and E2 levels were approximately 150 pg/mL per mature follicle), ovulation was triggered by single 250 mcg subcutaneous r-hCG injection. Duration of treatment cycle was up to adequate follicular response or maximum of 21 days.–5 / 12885 / 128
AS900672-Enriched 150 Microgram (Mcg)Single injection of AS900672-Enriched (hyperglycosylated r-hFSH), 150 mcg administered subcutaneously on S1 followed by a daily dose of follitropin alfa 150 IU subcutaneously starting from S6 up to S21 based upon ovarian response, until r-hCG administration day. When follicular response was adequate (that is, at least 1 follicle with a diameter of \>= 18 mm, two or more additional follicles with a diameter of \>= 16 mm, and E2 levels were approximately 150 pg/mL per mature follicle), ovulation was triggered by single 250 mcg subcutaneous r-hCG injection. Duration of treatment cycle was up to adequate follicular response or maximum of 21 days.–4 / 12884 / 128
Follitropin Alfa 150 IUFollitropin alfa (Gonal-f®) 150 IU administered subcutaneously once daily from S1 up to S21 based upon ovarian response, until r-hCG administration day. When follicular response was adequate (that is, at least 1 follicle with a diameter of \>= 18 mm, two or more additional follicles with a diameter of \>= 16 mm, and E2 levels were approximately 150 pg/mL per mature follicle), ovulation was triggered by single 250 mcg subcutaneous r-hCG injection. Duration of treatment cycle was up to adequate follicular response or maximum of 21 days.–6 / 13282 / 132

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
Female
Age
from 18 Years up to 36 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria : * Infertility and desire to conceive, justifying ART treatment * Age between 18 and 36 years, inclusive, at time of informed consent * Body mass index (BMI) 18 to 30 kilogram per square meter (kg/m\^2), inclusive * Regular spontaneous menstrual cycles of 21 to 35 days * Presence of both ovaries * Transvaginal ultrasound within 6 weeks and hysterosalpingogram, hysterosonogram or hysteroscopy within 2 years prior to beginning OCP treatment, showing no clinically significant uterine abnormality, which, in the Investigator's opinion, could impair embryo implantation or pregnancy continuation * Normal early follicular phase (Day 2-4) serum FSH level, according to the local laboratory * Normal serum thyroid stimulating hormone (TSH) level, according to the local laboratory * Papanicolaou (PAP) smear test without clinically significant abnormalities within the last 6 months prior to beginning oral contraceptive therapy, * Negative pregnancy test prior to beginning GnRH-agonist therapy * Male partner with semen analysis which is at least adequate for ICSI within last 6 months prior to beginning GnRH agonist therapy, according to local laboratory * Willing and able to comply with the protocol * Voluntary provision of written informed consent, prior to any study-related procedure that was 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, and * Willingness to provide follow-up information on babies born as part of this study * For subjects recruited at PK sub-study centers, voluntary provision of written informed consent to participate in the PK sub-study Exclusion Criteria: * Subject who require a starting dose of FSH greater than (\>) 150 international unit per day (IU/day), in the opinion of the Investigator * Screening ultrasound demonstrating more than 12 follicles less than (\<) 11 mm mean diameter in either ovary * Two or more previous ART cycles (consecutive or not) with poor response to gonadotrophin, defined as less than or equal to (=\<)3 oocytes retrieved * Three or more previous consecutive ART cycles without a biochemical or clinical pregnancy * Previous failure of fertilization with ICSI * A previous ART attempt in which there were no adequate or motile sperm before or after the processing of ejaculated sperm * Previous severe OHSS * History or presence of tumors of the hypothalamus or pituitary gland * History or presence of ovarian, uterine or mammary cancer * History or presence of ovarian enlargement or cyst of unknown etiology, or presence of ovarian cyst \>25 mm on the day of randomization * Presence of endometriosis Grade III - IV * Presence of uni- or bilateral hydrosalpinx * Abnormal gynecological bleeding of undetermined origin * Contraindication to being pregnant and/or carrying a pregnancy to term * History of \>= 3 clinical or preclinical (absence of gestational sac) miscarriages due to any cause * Extra-uterine pregnancy within the 3 months prior to randomization * Clinically significant concurrent disease that would have compromised subject safety or interfered with the study assessments * Known infection with human immunodeficiency virus (HIV), hepatitis B or C virus in the female or male partner * Known allergy or hypersensitivity to human gonadotrophin preparations or to compounds that are structurally similar to any of the other medications administered during the study * Any medical condition, which in the judgment of the Investigator may have interfere with the absorption, distribution, metabolism or excretion of r-hFSH * Any active substance abuse or history of drug, medication or alcohol abuse within 5 years before screening * ART cycle and/or ovarian stimulation within 30 days prior to informed consent * Entered previously into this study or simultaneous participation in another clinical trial * Subject is a smoker consuming more than 5 cigarettes per day * In the opinion of the Investigator, either assisted hatching or pre-implantation genetic diagnosis is indicated for the subject * Planning to undergo experimental procedures such as blastomere biopsy, or * Any known autoimmune disease

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