A Phase 3b Study to Evaluate Subject Satisfaction With Follitropin Alfa Injection in Oligoanovulatory Infertile Women Undergoing Ovulation Induction

Merck KGaA (EMD Serono)

Status and phase

Completed

Phase 3

Conditions

Infertility

Treatments

Device: Recombinant Human Choriogonadotropin (r-hCG)

Device: Follitropin alfa injected by Pen device

Study type

Interventional

Funder types

Industry

Identifiers

NCT00230815

24785

Details and patient eligibility

About

This is a prospective, open-label, multicenter, trial evaluating subject satisfaction and efficacy with follitropin alfa injection applied by Pen device compared with the subject's previous experience with injectable gonadotropins in oligoanovulatory infertile women undergoing ovulation induction

Enrollment

62 patients

Sex

Female

Ages

18 to 40 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Infertile woman wishing to conceive who has had at least 1 previous cycle of treatment with injectable gonadotropins within the past 6 months, excluding treatment with any gonadotropin multi-dose formulation in vials or administered by Pen device, whose physician has recommended that she undergo ovulation induction. This inclusion criterion is modified to include subjects who had previous treatment with any gonadotropin multi-dose formulation in vials, excluding those gonadotropins administered by a Pen device
Premenopausal and aged 18-40 years, inclusive
Ovulatory dysfunction as defined by any of the following (a) usual cycle length less than (<) 21 or greater than (>) 35 days with at least 6 menses per year (b) usual cycle length > 35 days with less than 6 menses per year. Subjects in this group must have a positive response to a progesterone challenge within the past 6 months or during the screening period
Spontaneous menses or a positive response to progestin withdrawal within 6 months of the start of gonadotropin therapy or positive response to clomiphene citrate withdrawal at least 30 days prior to start of gonadotropin therapy is acceptable to demonstrate induced menses
Normal Papanicolaou (PAP) smear within 6 months prior to initial visit
Male partner with an acceptable semen analysis within 6 months prior to study entry, according to the standard practice at the clinic, for ovulation induction. Use of donor sperm is acceptable
Body mass index (BMI) less than 35.0 kilogram per square meter (kg/m^2). BMI = Body Weight / Height x Height (BMI is equal to body weight [kilogram {kg}] divided by Height * Height [square meter {m^2}])
Patency and apparent normality of at least 1 fallopian tube with an ipsilateral functional ovary, as documented by an hysterosonogram or hysterosalpingography (HSG) within 3 years prior to study entry
Local laboratory screening results demonstrating the following, within the past year: (a) prolactin within normal limits (b) Follicle stimulating hormone (FSH) within the normal limit for the early follicular phase at the local laboratory (c) thyroid stimulating hormone (TSH) within normal limits. Subjects with low TSH levels who were receiving replacement therapy could be enrolled at the discretion of the Investigator
Been willing and able to comply with the protocol for the duration of the study
Voluntarily provided written informed consent and a subject authorization under Health Insurance Portability and Accountability Act (HIPAA), prior to any study-related procedure not part of normal medical care, with the understanding that consent could be withdrawn by the subject at any time without prejudice to their future medical care. The male partner must also have provided a written subject authorization under HIPAA

Exclusion criteria

Clinically significant systemic disease or clinically significant abnormal hematology, chemistry, or urinalysis results at screening
Previous treatment with any gonadotropin multi-dose formulation in vials or administered by Pen device in the past 6 months
Any significant allergic disease, which in the opinion of the Investigator could interfere with study treatment
Known infection with Human Immunodeficiency Virus (HIV), Hepatitis B or C virus
Prior severe Ovarian Hyperstimulation Syndrome (OHSS)
Significant allergic response to gonadotropin preparations
Ongoing pregnancy, any pregnancy within 3 months prior to study entry, or any contraindication to pregnancy or carrying pregnancy to term
Clinically significant abnormal findings evident on a transvaginal pelvic ultrasound performed within 2 cycles (maximum 90 days) of study entry
Poor response in a prior gonadotropin stimulation cycle, defined as an estradiol level < 100 pg/mL per mature follicle (>=16 mm mean diameter)
Prior excessive response to gonadotropin stimulation as defined by development of >3 mature follicles at a treatment dose of 75 IU FSH
Treatment with gonadotropins, clomiphene citrate, insulin-sensitizing agents (e.g., metformin, Avandia®) or Gonadotropin Releasing Hormone (GnRH) analogs within 1 month prior to study entry
Hypothyroidism (untreated). Subjects with low Thyroid Stimulating Hormone (TSH) levels who were receiving replacement therapy (e.g., Synthroid) could be enrolled at the discretion of the Investigator if local laboratory results demonstrated satisfactory thyroid function
Hyperprolactinemia (untreated)
Abnormal, undiagnosed, gynecological bleeding
Known current American Society Reproductive Medicine (ASRM) Stage 3 or 4 endometriosis
A residual ovarian cyst with a mean diameter >25 mm or an estradiol (E2) >100 pg/mL at the baseline examination
Three or more consecutive pregnancy losses, due to any cause
Known current substance abuse (including smokers consuming more than 5 cigarettes/day)
Previous participation (within 3 months prior to study entry) in another investigational drug or drug delivery system trial