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

NCT00505752 | Completed Phase 2 Results

• 1 other identifier: 27591
• Study Type: interventional
• Target: 520
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Infertility

Keywords

Assisted reproductive technology, follicle stimulating hormone

Outcome Measures

Primary Outcomes (1)

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

  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.

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

Secondary Outcomes (1)

• Percentage of Participants With Clinical Pregnancy

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

Study Arms (4)

AS900672-Enriched 50 mcg

EXPERIMENTAL

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

AS900672-Enriched 100 mcg

EXPERIMENTAL

Drug: AS900672-Enriched 100 mcg; Drug: Follitropin alfa 150 international unit (IU); Drug: Recombinant human chorionic gonadotropin (r-hCG)

AS900672-Enriched 150 mcg

EXPERIMENTAL

Drug: AS900672-Enriched 150 mcg; Drug: Follitropin alfa 150 international unit (IU); Drug: Recombinant human chorionic gonadotropin (r-hCG)

Follitropin alfa 150 IU

ACTIVE COMPARATOR

Drug: Follitropin alfa 150 international unit (IU); Drug: Recombinant human chorionic gonadotropin (r-hCG)

Interventions

AS900672-Enriched 50 microgram (mcg) DRUG

Single injection of AS900672-Enriched (hyperglycosylated recombinant human follicle stimulating hormone \[r-hFSH\]), 50 mcg will be administered subcutaneously on Stimulation Day 1 (S1). Duration of treatment cycle will be up to adequate follicular response or maximum of 21 days.

Also known as: Hyperglycosylated r-hFSH

AS900672-Enriched 50 mcg

AS900672-Enriched 100 mcg DRUG

Single injection of AS900672-Enriched (hyperglycosylated r-hFSH), 100 mcg will be administered subcutaneously on S1. Duration of treatment cycle will up to adequate follicular response or maximum of 21 days.

Also known as: Hyperglycosylated r-hFSH

AS900672-Enriched 100 mcg

AS900672-Enriched 150 mcg DRUG

Single injection of AS900672-Enriched (hyperglycosylated r-hFSH), 150 mcg will be administered subcutaneously on S1. Duration of treatment cycle will up to adequate follicular response or maximum of 21 days.

Also known as: Hyperglycosylated r-hFSH

AS900672-Enriched 150 mcg

Follitropin alfa 150 international unit (IU) DRUG

Follitropin alfa (Gonal-f®) 150 IU will be administered subcutaneously once daily from S1 up to Stimulation Day 21 (S21) based upon ovarian response, until recombinant human chorionic gonadotropin (r-hCG) administration day. Subjects who will be receiving AS900672-Enriched 50, 100 and 150 mcg will also receive daily dose of follitropin alfa 150 IU subcutaneously from Stimulation Day 6 (S6) up to S21. Duration of treatment cycle will be up to adequate follicular response or maximum of 21 days.

Also known as: Gonal-f®, Follicle stimulating hormone (FSH)

AS900672-Enriched 100 mcg; AS900672-Enriched 150 mcg; AS900672-Enriched 50 mcg; Follitropin alfa 150 IU

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, 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 will approximately 150 picogram per milliliter \[pg/mL\] per mature follicle).

Also known as: Ovidrel®, Choriogonadotropin alfa

AS900672-Enriched 100 mcg; AS900672-Enriched 150 mcg; AS900672-Enriched 50 mcg; Follitropin alfa 150 IU

Eligibility Criteria

• Age: 18 Years - 36 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Merck KGaA, Darmstadt, Germany: lead

Study Sites (1)

Local US Medical Information Office

Rockland, Massachusetts, 02370, United States

Location

MeSH Terms

Conditions

Infertility

Interventions

follitropin alfa; Follicle Stimulating Hormone; Chorionic Gonadotropin; Ovidrel

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Gonadotropins, Pituitary; Gonadotropins; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Pituitary Hormones, Anterior; Pituitary Hormones; Peptides; Amino Acids, Peptides, and Proteins; Placental Hormones; Pregnancy Proteins; Proteins

Results Point of Contact

• Title: Merck KGaA Communication Center
• Organization: Merck Serono, a division of Merck KGaA

service@merckgroup.com

+49-6151-72-5200

Study Officials

• Zourab Bebia, MD

  EMD Serono

  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: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 20, 2007
• First Posted: July 23, 2007
• Study Start: January 1, 2007
• Primary Completion: September 1, 2008
• Study Completion: September 1, 2008
• Last Updated: February 13, 2014
• Results First Posted: July 24, 2013

Record last verified: 2014-01

Locations

US (1)